Pioneer Catheter (Crosspoint TransAccess Catheter); Model TA-XP-001; Product is manufactured and distributed by Medtroni
FDA device recall Z-0208-2007 · posted 2006-11-22 · Terminated
Recall details
- Recalling firm
- Medtronic Vascular
- Reason for recall
- Sterility may be compromised as evidenced by a loss of package integrity.
- Action taken
- On 11/1/06, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.
- Root cause
- Other
- Status
- Terminated
- Product code
- ITX
- Quantity affected
- 502
- Distribution
- Worldwide, including USA, Switzerland, France, Belgium, Germany.
- Date initiated
- 2006-11-01
- Date posted
- 2006-11-22
- Date terminated
- 2007-12-05
- Location
- Santa Rosa, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001 (K031920) | Trans Vascular Incorporated | 2003-07-23 |