Boston Scientific Corporation: Catheter Systems Recalled for Potential Holes in Sterile Packaging

Agency Publication Date: September 13, 2024

Summary

Boston Scientific Corporation is recalling approximately 140 units of Flexima and vanSonnenberg catheter systems and kits due to the potential for holes in the clear sterile barrier of the device pouch. These kits are used for various medical drainage procedures, including biliary, nephrostomy, and abdominal fluid collections. If the sterile barrier is compromised, the device may become contaminated, potentially leading to patient infection. These medical devices were distributed in the United States and several other countries between early 2024 and mid-2024.

Risk

Holes in the device's protective pouch can allow bacteria and other contaminants to reach the catheter before use. Using a non-sterile device during a surgical procedure can cause serious internal infections or other health complications for the patient.

What You Should Do

Identify if you have any of the following affected catheter systems: Flexima APDL, Flexima Biliary, Flexima Nephrostomy, vanSonnenberg Sump Locking Pigtail, or VTC Nephrostomy kits.
Check your product packaging for the following specific Lot and Material (REF) numbers: Flexima APDL (REF M001271960, Lot 33540319; REF M001271970, Lot 33471466), Flexima Biliary (REF M001271650, Lot 33512376), Flexima Nephrostomy (REF M001271860, Lot 33550953), vanSonnenberg Sump (REF M001273090, Lot 33512377), or VTC Nephrostomy (REF M001245300, Lot 33751204).
Confirm the GTIN/UDI barcode numbers on the package: 0871472932347, 0871472932348, 0871472932327, 0871472932337, 0871472913774, or 0871472904856.
Immediately stop using any products identified as part of these affected lots and quarantine them to prevent accidental use.
Contact your healthcare provider or Boston Scientific Corporation for specific instructions on how to return the affected units and to inquire about replacements or potential refunds.
For additional questions or to report issues, contact 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

Contact healthcare provider or manufacturer

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

Affected Products

Product: Flexima APDL Drainage Catheter System and Kit

Model / REF:

REF M001271960

REF M001271970

UPC Codes:

0871472932347

0871472932348

Lot Numbers:

33540319 (Exp. 03/01/2027)

33471466 (Exp. 02/21/2027)

Product: Flexima Regular Kit Biliary Catheter System Kit

Model / REF:

REF M001271650

UPC Codes:

0871472932327

Lot Numbers:

33512376 (Exp. 02/26/2027)

Product: Flexima Regular Kit Nephrostomy Catheter System Kit

Model / REF:

REF M001271860

UPC Codes:

0871472932337

Lot Numbers:

33550953 (Exp. 03/04/2027)

Product: vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit

Model / REF:

REF M001273090

UPC Codes:

0871472913774

Lot Numbers:

33512377 (Exp. 02/26/2027)

Product: VTC Regular Kit Nephrostomy Catheter System Kit

Model / REF:

REF M001245300

UPC Codes:

0871472904856

Lot Numbers:

33751204 (Exp. 04/03/2027)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95186

Status: Active

Manufacturer: Boston Scientific Corporation

Sold By: Hospitals; Medical supply distributors

Manufactured In: United States

Units Affected: 5 products (89 units; 32 units; 10 units; 4 units; 5 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 any of the following affected catheter systems: Flexima APDL, Flexima Biliary, Flexima Nephrostomy, vanSonnenberg Sump Locking Pigtail, or VTC Nephrostomy kits.

Check your product packaging for the following specific Lot and Material (REF) numbers: Flexima APDL (REF M001271960, Lot 33540319; REF M001271970, Lot 33471466), Flexima Biliary (REF M001271650, Lot 33512376), Flexima Nephrostomy (REF M001271860, Lot 33550953), vanSonnenberg Sump (REF M001273090, Lot 33512377), or VTC Nephrostomy (REF M001245300, Lot 33751204).

Confirm the GTIN/UDI barcode numbers on the package: 0871472932347, 0871472932348, 0871472932327, 0871472932337, 0871472913774, or 0871472904856.

Immediately stop using any products identified as part of these affected lots and quarantine them to prevent accidental use.

Contact your healthcare provider or Boston Scientific Corporation for specific instructions on how to return the affected units and to inquire about replacements or potential refunds.

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

Affected Products

Product: Flexima APDL Drainage Catheter System and Kit

Model / REF:

REF M001271960

REF M001271970

UPC Codes:

0871472932347

0871472932348

Lot Numbers:

33540319 (Exp. 03/01/2027)

33471466 (Exp. 02/21/2027)

Product: Flexima Regular Kit Biliary Catheter System Kit

Model / REF:

REF M001271650

UPC Codes:

0871472932327

Lot Numbers:

33512376 (Exp. 02/26/2027)

Product: Flexima Regular Kit Nephrostomy Catheter System Kit

Model / REF:

REF M001271860

UPC Codes:

0871472932337

Lot Numbers:

33550953 (Exp. 03/04/2027)

Product: vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit

Model / REF:

REF M001273090

UPC Codes:

0871472913774

Lot Numbers:

33512377 (Exp. 02/26/2027)

Product: VTC Regular Kit Nephrostomy Catheter System Kit

Model / REF:

REF M001245300

UPC Codes:

0871472904856

Lot Numbers:

33751204 (Exp. 04/03/2027)