Boston Scientific Corporation: Medical Device Recall in 2024 - (Recall #: Z-3147-2024)

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 APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail

Product Classification:

Class II

Date Initiated: July 18, 2024

Date Posted: September 25, 2024

Recall Number: Z-3147-2024

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: 89 units

Code Information:

a) GTIN/UDI 0871472932347, Lot # 33540319, Exp. 03/01/2027; b) GTIN/UDI 0871472932348, Lot # 33471466, Exp. 02/21/2027

Distribution Pattern:

US, Colombia, Philippines, Russia

Voluntary or Mandated:

Voluntary: Firm initiated