Telesheath Left Atrial Introducer System Right Superior. Telesheath Catheter Two-Piece Introducer Kit with Hemostasis Va
FDA device recall Z-1426-04 · posted 2004-09-01 · Terminated
Recall details
- Recalling firm
- St. Jude Medical/Daig Division
- Reason for recall
- St. Jude Medical received two complaints from customers involving the Telesheath Left Atrial Introducer System side arm detaching from the hub of the inner sheath. Subsequent testing of Telesheath inventory at St. Jude Medical indicated that the side arm from the inner sheath can detach during routine handling and manipulation, and occurs on a random basis.
- Action taken
- 100% of customers were notified by a personal visit by a St. Jude Medical representative, starting 8/4/2004. Letters were given by the representative to the consignee concerning the recall.
- Root cause
- Other
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 55 kits
- Distribution
- US, Canada, Belgium, Hong Kong, and Japan.
- Date initiated
- 2004-08-04
- Date posted
- 2004-09-01
- Date terminated
- 2005-11-21
- 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 INTRA-CARDIAC INTRODUCER (K982187) | Daig Corp. | 1998-09-16 |
| FAST-CATH (TM) INTRA-CARDIAC INTRODUCER (K973840) | Daig Corp. | 1998-05-21 |
| FAST-CATH TRANSSEPTAL CATHETER INTRODUCER (K964518) | Daig Corp. | 1997-05-14 |