Recall Z-1801-2024 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Medtronic Perfusion Systems
Medtronic Cardioplegia Adapters: a) DLP 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009, b) DLP 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25010, c) DLP 30.5 cm (12 in) Multiple Perfusion Set, Model Number 14003, d) DLP 38.1 cm (15 in) Multiple Perfusion Set, Model Number 14000, e) DLP 50.8 cm (20 in) Extension Line Adapter, Model Number
| 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 | 6290 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182586 | DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Car Medtronic, Inc., Oct 19, 2018 |