Boston Scientific Corporation: Medical Device Recall in 2025 - (Recall #: Z-2618-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);

Product Classification:

Class II

Date Initiated: August 28, 2025

Date Posted: October 1, 2025

Recall Number: Z-2618-2025

Event ID: 97529

Reason for Recall:

The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.

Status: Ongoing

Product Quantity: 156 units

Code Information:

Instructions for Use: 51878205; Pre-Printed Ouch: 51368417; 1. UPN (REF): M00547030 (9-12mm Below); UDI-DI: 08714729790280; Lot Numbers: 36398057; 2. UPN (REF): (1) M00547000(9-12mm Above); UDI-DI: 08714729790266; Lot Numbers: 36426495;

Distribution Pattern:

US Nationwide distribution in the states of CA, CO, GA, ID, IL, IN, MA, ME, MI, MS, NC, OH, OK, PA, SD, TN, TX, VA, WA.

Voluntary or Mandated:

Voluntary: Firm initiated