Medtronic DLP VAD Venous Cannula for Ventricular Assist, Models 95036 and CB95036.
FDA device recall Z-1489-04 · posted 2004-09-29 · Terminated
Recall details
- Recalling firm
- Medtronic Inc
- Reason for recall
- Spiral tip from DLP VAD cannula may be loose and potentially detach during use.
- Action taken
- A notification letter dated September 23, 2004 was sent by certified mail to US customers. The letter cautions the customer about the possibility of tip detachment and requests the impacted product to be returned to Medtronic for replacement. Customers are requested to complete a Field Corrective Action Certificate acknowledging the receipt of this information.
- Root cause
- Other
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 753 units, 203 distributed in US to 24 customers.
- Distribution
- Nationwide throughout the United States and worldwide.
- Date initiated
- 2004-09-15
- Date posted
- 2004-09-29
- Date terminated
- 2005-11-03
- Location
- Minneapolis, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE (K891687) | Medtronic Blood Systems, Inc. | 1989-05-31 |
| VENOUS RETURN CATHETER SS-1 (K845045) | Dlp, Inc. | 1985-04-03 |