Boston Scientific Corporation: Medical Device Recall in 2024 - (Recall #: Z-3148-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail

Product Classification:

Class II

Date Initiated: July 18, 2024

Date Posted: September 25, 2024

Recall Number: Z-3148-2024

Event ID: 95186

Reason for Recall:

There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.

Status: Ongoing

Product Quantity: 32 units

Code Information:

GTIN/UDI 0871472932327, Lot # 33512376, exp. 02/26/2027

Distribution Pattern:

US, Colombia, Philippines, Russia

Voluntary or Mandated:

Voluntary: Firm initiated