Recall Z-1797-2024 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Medtronic Perfusion Systems
Medtronic Left Heart Vent Catheters: a) DLP Intracardiac Sump 20 Fr, Model Number 12012, b) DLP Left Heart Vent Catheter 10 Fr., Model Number 12008, c) DLP Left Heart Vent Catheter 13 Fr., Model Number 12001, d) DLP Left Heart Vent Catheter 13 Fr., Model Number 12113, e) DLP Left Heart Vent Catheter 16 Fr., Model Number 12016, f) DLP Left Heart Vent Catheter 20 Fr. Model Number 12002, g) D
| Date | May 10, 2024 (initiated Mar 19, 2024) |
| Status | Open, Classified |
| Reason | Potential for unsealed sterile packing. |
| Root cause | Process control |
| Action | Medtronic issued an Urgent Medical Device Recall notice to its consignees on 03/19/2024 via letter (UPS). The notice explained the issue, potential risk, and requested the consignee identify and return the product. Consignee was directed to forward the notice to all affected parties. For questions, the consignee was directed to contact their Medtronic field representative. |
| Quantity | 13954 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K850385 | INTRACARDIAC SUMP 12010 Dlp, Inc., Apr 29, 1985 |