CleverCut and Olympus Single Use Sphincterotomes Recalled for Deforming Risk

Agency Publication Date: February 5, 2026

Summary

Olympus Corporation of the Americas is recalling 524,317 Single Use and Disposable Sphincterotomes, including the CleverCut V brand, because some devices did not undergo a required manufacturing process called thermoforming. Without this step, these surgical instruments used for papillotomy (a procedure to widen the opening of the bile or pancreatic duct) can deform during use and lose performance. Consumers and medical facilities should check their inventory for affected model numbers and catalog numbers. Because these are clinical surgical instruments, healthcare providers should contact the manufacturer or their distributor to arrange for the return or correction of the devices.

Risk

The instruments may fail to perform as intended or deform during a procedure if they were not properly heat-shaped during manufacturing. This could lead to surgical delays, ineffective treatment, or potential injury to the patient's internal ducts during the high-frequency current application.

What You Should Do

Identify if you have any of the affected Olympus or CleverCut Sphincterotomes by checking the Model/Catalog Number and Material REF on the device packaging.
Affected models include KD-V411M-0320, KD-VC431Q-0720, KD-431Q-0720, KD-V411M-0330, KD-V411M-0720, KD-V411M-0725, KD-V411M-0730, KD-V431M-0720, KD-V431M-0730, KD-VC431Q-0730, KD-VC411Q-0720, KD-VC411Q-0730, KD-VC411Q-0320, KD-VC411Q-0330, KD-VC412Q-0215, KD-VC433Q-0720, KD-VC433Q-0730, KD-411Q-0720, KD-411Q-0730, KD-401Q-0330, KD-401Q-0720, KD-401Q-0730, KD-V411M-1520, KD-V411M-1530, KD-V411M-3030, KD-401Q-0320, KD-401Q-0725, KD-V411M-3020, KD-V411M-3025, and KD-VC411Q-0725. See the Affected Products section below for the full list of affected codes.
Stop using the recalled device immediately to avoid potential procedure complications.
Contact Olympus Corporation of the Americas or your authorized distributor to arrange for the return, replacement, or correction of the affected units.
For further questions regarding this recall, call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: CleverCut Single Use 3-Lumen Sphincterotome V

Model / REF:

KD-V411M-0320

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170183973

04953170466274

04953170380556

Material REF: N1089430, N1089410, N5411130

Product: Single Use Sphincterotome V (Distal Wire guided)

Model / REF:

KD-VC431Q-0720

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170466427

Material REF: N5391530, N5391510, N5777830

Product: Disposable Triple Lumen Sphincterotome

Model / REF:

KD-431Q-0720

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170042362

04953170463778

04953170466564

Material REF: 5859230, N6221831, N6221840

Product: Single Use 3-Lumen Sphincterotome V

Model / REF:

KD-V411M-0330

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170380563

Material REF: N1089530, N1089510, N5411230

Product: Single Use 3-Lumen Sphincterotome V

Model / REF:

KD-V411M-0720

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170184017

04953170380570

Material REF: N1089610, N5411330

Product: Single Use 3-Lumen Sphincterotome V

Model / REF:

KD-V411M-0725

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170380587

Material REF: N1089710, N5411430

Product: Single Use 3-Lumen Sphincterotome V

Model / REF:

KD-V411M-0730

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170380594

Material REF: N1089810, N5411530

Product: Single Use 3-Lumen Sphincterotome V

Model / REF:

KD-V431M-0720

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170184178

Material REF: N1090410, N1090430, N5411930

Product: Single Use 3-Lumen Sphincterotome V

Model / REF:

KD-V431M-0730

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170380648

Material REF: N1090530, N1090510, N5412030

Product: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)

Model / REF:

KD-VC431Q-0730

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170466434

Material REF: N5391610, N5391630, N5777930

Product: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)

Model / REF:

KD-VC411Q-0720

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170371110

Material REF: N5391210, N5391230, N5777530

Product: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)

Model / REF:

KD-VC411Q-0730

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170399329

Material REF: N5391330, N5391310, N5777630

Product: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)

Model / REF:

KD-VC411Q-0320

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170466403

Material REF: N5391030, N5391010, N5777330

Product: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)

Model / REF:

KD-VC411Q-0330

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170371097

Material REF: N5391130, N5391110, N5777430

Product: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)

Model / REF:

KD-VC412Q-0215

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170371158

Material REF: N5391410, N5391430, N5777730

Product: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)

Model / REF:

KD-VC433Q-0720

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170371219

Material REF: N5391710, N5391730, N5778030

Product: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)

Model / REF:

KD-VC433Q-0730

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170371233

Material REF: N5391830, N5391810, N5778130

Product: Disposable Triple Lumen Sphincterotome

Model / REF:

KD-411Q-0720

Lot Numbers:

All Lots with a valid expiration date

Material REF: 5858030

Product: Disposable Triple Lumen Sphincterotome

Model / REF:

KD-411Q-0730

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170466557

Material REF: 5858230, N6221731, N6221740

Product: Disposable Triple Lumen Sphincterotome

Model / REF:

KD-401Q-0330

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170041617

Material REF: 5856730

Product: Disposable Triple Lumen Sphincterotome

Model / REF:

KD-401Q-0720

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170041648

Material REF: 5856830

Product: Disposable Triple Lumen Sphincterotome

Model / REF:

KD-401Q-0730

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170041709

Material REF: 5857030

Product: Single Use 3-Lumen Sphincterotome V

Model / REF:

KD-V411M-1520

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170380600

Material REF: N5411630, N1089910

Product: Single Use 3-Lumen Sphincterotome V

Model / REF:

KD-V411M-1530

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170380617

Material REF: N5411730, N1090010

Product: Single Use 3-Lumen Sphincterotome V

Model / REF:

KD-V411M-3030

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170184154

Material REF: N5411830, N1090310

Product: Disposable Triple Lumen Sphincterotome

Model / REF:

KD-401Q-0320

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170041587

Material REF: 5856630

Product: Disposable Triple Lumen Sphincterotome

Model / REF:

KD-401Q-0725

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170041587

Material REF: 5856930

Product: Single Use 3-Lumen Sphincterotome V

Model / REF:

KD-V411M-3020

Lot Numbers:

All Lots with a valid expiration date

Material REF: N1090110

Product: Single Use 3-Lumen Sphincterotome V

Model / REF:

KD-V411M-3025

Lot Numbers:

All Lots with a valid expiration date

Material REF: N1090210

Product: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)

Model / REF:

KD-VC411Q-0725

Lot Numbers:

All Lots with a valid expiration date

Material REF: N5424710

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 98252

Status: Active

Manufacturer: Olympus Corporation of the Americas

Sold By: Authorized Medical Distributors; Specialty Medical Retailers

Manufactured In: United States

Units Affected: 30 products (72023 units (3920 US, 68103 OUS); 12641 units (8789 US, 3852 OUS); 7689 units (7501 US, 188 OUS); 33433 units (36 US, 33397 OUS); 65117 units (9707 US, 55410 OUS); 136037 units (9959 US, 126078 OUS); 86303 units (1803 US, 84500 OUS); 30489 units (11779 US, 18710 OUS); 17655 units (2411 US, 15244 OUS); 4183 units (821 US, 3362 OUS); 10008 units (3038 US, 6970 OUS); 10257 units (274 US, 9983 OUS); 5946 units (2208 US, 3738 OUS); 5089 units (30 US, 5059 OUS); 1918 units (413 US, 1505 OUS); 1504 units (350 US, 1154 OUS); 93 units (5 US, 88 OUS); 125 units (7 US, 118 OUS); 887 units (650 US, 237 OUS); 886 units (OUS only); 1072 units (OUS only); 1490 units (OUS only); 3954 units (OUS only); 7046 units (OUS only); 2344 units (OUS only); 999 units (OUS only); 1980 units (OUS only); 650 units (OUS only); 1025 units (OUS only); 1474 units (all OUS))

Distributed To: Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have any of the affected Olympus or CleverCut Sphincterotomes by checking the Model/Catalog Number and Material REF on the device packaging.

Affected models include KD-V411M-0320, KD-VC431Q-0720, KD-431Q-0720, KD-V411M-0330, KD-V411M-0720, KD-V411M-0725, KD-V411M-0730, KD-V431M-0720, KD-V431M-0730, KD-VC431Q-0730, KD-VC411Q-0720, KD-VC411Q-0730, KD-VC411Q-0320, KD-VC411Q-0330, KD-VC412Q-0215, KD-VC433Q-0720, KD-VC433Q-0730, KD-411Q-0720, KD-411Q-0730, KD-401Q-0330, KD-401Q-0720, KD-401Q-0730, KD-V411M-1520, KD-V411M-1530, KD-V411M-3030, KD-401Q-0320, KD-401Q-0725, KD-V411M-3020, KD-V411M-3025, and KD-VC411Q-0725. See the Affected Products section below for the full list of affected codes.

Stop using the recalled device immediately to avoid potential procedure complications.

Contact Olympus Corporation of the Americas or your authorized distributor to arrange for the return, replacement, or correction of the affected units.

For further questions regarding this recall, call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: CleverCut Single Use 3-Lumen Sphincterotome V

Model / REF:

KD-V411M-0320

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170183973

04953170466274

04953170380556

Material REF: N1089430, N1089410, N5411130

Product: Single Use Sphincterotome V (Distal Wire guided)

Model / REF:

KD-VC431Q-0720

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170466427

Material REF: N5391530, N5391510, N5777830

Product: Disposable Triple Lumen Sphincterotome

Model / REF:

KD-431Q-0720

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170042362

04953170463778

04953170466564

Material REF: 5859230, N6221831, N6221840

Product: Single Use 3-Lumen Sphincterotome V

Model / REF:

KD-V411M-0330

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170380563

Material REF: N1089530, N1089510, N5411230

Product: Single Use 3-Lumen Sphincterotome V

Model / REF:

KD-V411M-0720

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170184017

04953170380570

Material REF: N1089610, N5411330

Product: Single Use 3-Lumen Sphincterotome V

Model / REF:

KD-V411M-0725

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170380587

Material REF: N1089710, N5411430

Product: Single Use 3-Lumen Sphincterotome V

Model / REF:

KD-V411M-0730

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170380594

Material REF: N1089810, N5411530

Product: Single Use 3-Lumen Sphincterotome V

Model / REF:

KD-V431M-0720

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170184178

Material REF: N1090410, N1090430, N5411930

Product: Single Use 3-Lumen Sphincterotome V

Model / REF:

KD-V431M-0730

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170380648

Material REF: N1090530, N1090510, N5412030

Product: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)

Model / REF:

KD-VC431Q-0730

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170466434

Material REF: N5391610, N5391630, N5777930

Product: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)

Model / REF:

KD-VC411Q-0720

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170371110

Material REF: N5391210, N5391230, N5777530

Product: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)

Model / REF:

KD-VC411Q-0730

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170399329

Material REF: N5391330, N5391310, N5777630

Product: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)

Model / REF:

KD-VC411Q-0320

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170466403

Material REF: N5391030, N5391010, N5777330

Product: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)

Model / REF:

KD-VC411Q-0330

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170371097

Material REF: N5391130, N5391110, N5777430

Product: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)

Model / REF:

KD-VC412Q-0215

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170371158

Material REF: N5391410, N5391430, N5777730

Product: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)

Model / REF:

KD-VC433Q-0720

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170371219

Material REF: N5391710, N5391730, N5778030

Product: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)

Model / REF:

KD-VC433Q-0730

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170371233

Material REF: N5391830, N5391810, N5778130

Product: Disposable Triple Lumen Sphincterotome

Model / REF:

KD-411Q-0720

Lot Numbers:

All Lots with a valid expiration date

Material REF: 5858030

Product: Disposable Triple Lumen Sphincterotome

Model / REF:

KD-411Q-0730

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170466557

Material REF: 5858230, N6221731, N6221740

Product: Disposable Triple Lumen Sphincterotome

Model / REF:

KD-401Q-0330

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170041617

Material REF: 5856730

Product: Disposable Triple Lumen Sphincterotome

Model / REF:

KD-401Q-0720

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170041648

Material REF: 5856830

Product: Disposable Triple Lumen Sphincterotome

Model / REF:

KD-401Q-0730

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170041709

Material REF: 5857030

Product: Single Use 3-Lumen Sphincterotome V

Model / REF:

KD-V411M-1520

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170380600

Material REF: N5411630, N1089910

Product: Single Use 3-Lumen Sphincterotome V

Model / REF:

KD-V411M-1530

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170380617

Material REF: N5411730, N1090010

Product: Single Use 3-Lumen Sphincterotome V

Model / REF:

KD-V411M-3030

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170184154

Material REF: N5411830, N1090310

Product: Disposable Triple Lumen Sphincterotome

Model / REF:

KD-401Q-0320

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170041587

Material REF: 5856630

Product: Disposable Triple Lumen Sphincterotome

Model / REF:

KD-401Q-0725

Lot Numbers:

All Lots with a valid expiration date

UDI:

04953170041587

Material REF: 5856930

Product: Single Use 3-Lumen Sphincterotome V

Model / REF:

KD-V411M-3020

Lot Numbers:

All Lots with a valid expiration date

Material REF: N1090110

Product: Single Use 3-Lumen Sphincterotome V

Model / REF:

KD-V411M-3025

Lot Numbers:

All Lots with a valid expiration date

Material REF: N1090210

Product: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)

Model / REF:

KD-VC411Q-0725

Lot Numbers:

All Lots with a valid expiration date

Material REF: N5424710

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 98252

Status: Active

Manufacturer: Olympus Corporation of the Americas

Sold By: Authorized Medical Distributors; Specialty Medical Retailers

Manufactured In: United States