Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon/8.5 mm balloon Catalog # 4544
FDA device recall Z-0551-03 · posted 2003-02-08 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Breach in sterile barrrier may compromise sterility
- Action taken
- Boston Scientific/Microvasive, Natick, MA initiated a voluntary recall by letter dated 1/27/03, and mailed 1/29/03. Accounts were requested to remove affected lots and return product to Boston Scientific. A verification form was provided to monitor effectiveness of the recall notification. Non-reponders will be recontacted.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 22 units
- Distribution
- Nationwide
- Date initiated
- 2003-01-29
- Date posted
- 2003-02-08
- Date terminated
- 2004-03-10
- Location
- Natick, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXTRACTORRX (K970052) | Boston Scientific Corp | 1997-03-25 |