FastCath Transseptal Catheter Introducers with Hemostasis Valve, DAIG division of St. Jude Medical, Minnetonka, MN, cons
FDA device recall Z-0535-2007 · posted 2007-03-01 · Terminated
Recall details
- Recalling firm
- St. Jude Medical / Daig Division
- Reason for recall
- Limited number of FastCath Transseptal Catheter Introducers (REF #406850) are susceptible to the irrigation extension tube on the side port becoming disconnected when a pull force is applied.
- Action taken
- The affected customers were notified on 10/5/06 by letter.
- Root cause
- Other
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 40 Units
- Distribution
- Nationwide.
- Date initiated
- 2006-10-05
- Date posted
- 2007-03-01
- Date terminated
- 2007-05-25
- Location
- Minnetonka, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FAST-CATH TRANSSEPTAL CATHETER INTRODUCER (K964518) | Daig Corp. | 1997-05-14 |