Boston Scientific, Back-Up Meier Steerable Guidewires, Sterilized using ethylene oxide. The steerable guidewires are mad
FDA device recall Z-1760-2010 · posted 2010-06-04 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Boston Scientific Corporation is conducting a Medical Device Recall of certain lots/batches of its Back-up Meier Steerable Guidewires. Through their internal inspection process, they identified that the polytetrafluoroethylene (PTFE) coating on the gold plated distal coil of the Back-up Meier Steerable Guidewires of the identified lots/batches have the potential for PTFE delamination. Inconsist
- Action taken
- Consignees were sent a Boston Scientific "Urgent Medical Device Recall" letter dated April 19, 2010. The letter was addressed to Risk Manger/Field Action Contact. The letter described the problem and product affected and recommended that to immediately discontinue use of and segregate recalled product. They also requested the consignee to complete and return the Account Reply Verification Tracking Form. Customers with questions are directed to the firm's Field Action Coordinator at (763-) 494-1417.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DQX
- Quantity affected
- US 885 single units (177 boxes), OUS 630 single units (126 boxes)
- Distribution
- AL, AZ, AR, CA, CT, FL, GA, IL, IN, IA, KS, KY, ME, MD, MA, MS, MO, NJ, NM, NY, NC, OH, OR, PA, SC, SD, TN TX, VT, VA, WA. SWITZERLAND, GERMANY, FINLAND, FRANCE, ITALY, JORDAN, POLAND, SWEDEN, CANADA.
- Date initiated
- 2010-04-19
- Date posted
- 2010-06-04
- Date terminated
- 2011-12-10
- Location
- Maple Grove, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BACK-UP MEIER STEERABLE GUIDEWIRE (K020283) | Boston Scientific Corp | 2002-02-11 |
| BACK-UP MEIER GUIDEWIRE (K011906) | Boston Scientific Corp | 2001-08-13 |