CooperSurgical, Inc.: H/S Elliptosphere Catheters Recalled for Potential Failure and Leakage

Agency Publication Date: December 6, 2023

Summary

CooperSurgical is recalling 332 units of various H/S Elliptosphere Catheters and Catheter Sets used for administering contrast media during uterine and fallopian tube imaging procedures. The recall was initiated because an incorrect bonding material was used during assembly, which may cause the catheter to fail. This failure can result in component parts detaching, breaking, or leaking, which could lead to procedure delays and potential patient harm. Consumers should contact their healthcare provider or the manufacturer regarding these affected medical devices.

Risk

The use of incorrect adhesive may cause the catheter to break or leak during a medical procedure, potentially leading to a delay in treatment or the detachment of components within the patient.

What You Should Do

Identify if you have the affected products by checking for Model 61-3005 (H/S Elliptosphere Cath 5 Fr), Model 61-4005 (H/S Elliptosphere Cath 5 FR Set), or Model 61-4005S (H/S Catheter Set FR 5 with Integrated Stylet).
Check the specific serial numbers (SN) and UDI-DI codes on the product packaging: look for SN 312868 (UDI-DI 60888937016408), SN 313121 or 313568 (UDI-DI 60888937016446), and SN 309967 (UDI-DI 60888937016453).
Contact your healthcare provider or CooperSurgical, Inc. directly at 1-800-243-2974 for instructions on returning affected units and to discuss potential refunds or replacements.
If you are a medical professional, immediately stop using the affected lot numbers and quarantine any remaining stock.
For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer instructions for device recall

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr

Model / REF:

61-3005

UPC Codes:

60888937016408

Lot Numbers:

312868

Product: Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set

Model / REF:

61-4005

UPC Codes:

60888937016446

Lot Numbers:

313121

313568

Product: CooperSurgical H/S CATHETER SET FR 5 with Integrated Stylet

Model / REF:

61-4005S

UPC Codes:

60888937016453

Lot Numbers:

309967

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93239

Status: Active

Manufacturer: CooperSurgical, Inc.

Sold By: hospitals; medical clinics

Manufactured In: United States

Units Affected: 3 products (73 units; 169 units; 90 units)

Distributed To: Nationwide

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 the affected products by checking for Model 61-3005 (H/S Elliptosphere Cath 5 Fr), Model 61-4005 (H/S Elliptosphere Cath 5 FR Set), or Model 61-4005S (H/S Catheter Set FR 5 with Integrated Stylet).

Check the specific serial numbers (SN) and UDI-DI codes on the product packaging: look for SN 312868 (UDI-DI 60888937016408), SN 313121 or 313568 (UDI-DI 60888937016446), and SN 309967 (UDI-DI 60888937016453).

Contact your healthcare provider or CooperSurgical, Inc. directly at 1-800-243-2974 for instructions on returning affected units and to discuss potential refunds or replacements.

If you are a medical professional, immediately stop using the affected lot numbers and quarantine any remaining stock.

For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr

Model / REF:

61-3005

UPC Codes:

60888937016408

Lot Numbers:

312868

Product: Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set

Model / REF:

61-4005

UPC Codes:

60888937016446

Lot Numbers:

313121

313568

Product: CooperSurgical H/S CATHETER SET FR 5 with Integrated Stylet

Model / REF:

61-4005S

UPC Codes:

60888937016453

Lot Numbers:

309967