FDA Medical devices recall ·
Extractor Pro RX Retrieval Balloon Catheter recall
- Recall number
- Z-2618-2025
- Date
- (initiated August 28, 2025)
- Company / brand
- Boston Scientific Corporation
100 Boston Scientific Way, Marlborough, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 156 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
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.
States: California Colorado Georgia Idaho Illinois Indiana Massachusetts Maine Michigan Mississippi North Carolina Ohio Oklahoma Pennsylvania South Dakota Tennessee Texas Virginia Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2618-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.