Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# DESCRIPTION 435428-01 M001273030
FDA device recall Z-1340-2009 · posted 2009-05-21 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, sutures were separated from the catheter and remained in the patient.
- Action taken
- Consignees were sent a Boston Scientific " Urgent Medical Device Field Correction Notification" letter dated March 18, 2009. The letter was addressed to "The Hospital Field Action Contact". The letter described the problem, product affected and the revised catheter removal instructions. They also requested the return of the Acknowledgement Form.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- FFA
- Quantity affected
- 586,276 US; 276,013 OUS total for all products
- Distribution
- Worldwide Distribution -- USA including DC, Puerto Rico and Guam and countries of United Arab Emirates Austria, Bosnia and Herzegovina, Bahrain, Switzerland, Germany, Egypt, Spain, Finland, France, Gr
- Date initiated
- 2009-03-18
- Date posted
- 2009-05-21
- Date terminated
- 2012-02-23
- 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 |
|---|---|---|
| CATHETERS, BILIARY CATHETERS, UROLOGICAL (K944290) | Boston Scientific Corp | 1994-12-08 |