Recall Z-3128-2024 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Medtronic Perfusion Systems
Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
| Date | Sep 12, 2024 (initiated Jul 9, 2024) |
| Status | Open, Classified |
| Reason | During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae - right angle metal tip (Model 67312). |
| Root cause | Under Investigation by firm |
| Action | Medtronic issued an Urgent: Medical Device Recall notice to its consignees on 07/09/2024 via UPS. The notice explained the issue, potential risk, and requested return of the affected device. Those who further distributed the device were directed to share the notice with those to whom the affected product was distributed. |
| Quantity | 290 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Cambodia, Greece, Ireland, Italy, Saudi Arabia, Switzerland, United Kingdom, Viet Nam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120988 | DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT Medtronic, Inc., Jul 25, 2012 |