Atlantis PV Peripheral Imaging Catheter, model number H749364560, catalog number 36456, manufactured by Boston Scientifi
FDA device recall Z-0837-2009 · posted 2009-01-28 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Product is mislabeled as having a shelf life of 3 years, where the actual shelf life is 1 year.
- Action taken
- Recall initiated on October 6, 2008, and notification letters sent on October 8, 2008. Letters were sent via FedEx. Responses are being tracked along with delivery verification. For additional information contact Boston Scientific Corporation at 1-508-652-5594.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- ITX
- Quantity affected
- 1033 units
- Distribution
- Worldwide Distribution --- USA including Puerto Rico and country of Panama
- Date initiated
- 2008-10-09
- Date posted
- 2009-01-28
- Date terminated
- 2009-07-27
- Location
- Fremont, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ATLANTIS PVIMAGING CATHETER, MODEL H749364560 (K080272) | Boston Scientific Corp | 2008-03-11 |