Recall Z-0289-2025 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Medtronic Perfusion Systems
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
| Date | Nov 4, 2024 (initiated Oct 3, 2024) |
| Status | Open, Classified |
| Reason | There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal |
| Root cause | Process control |
| Action | Medtronic Cardiac Surgery issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 10/03/2024 via USPS first class mail. The notice explained the problem with the device, potential risk, and requested the affected product be quarantined pending return. The notice is to be shared with all individuals with each facility as appropriate, and the notice distributed to all facilities to which the affected devices was shipped. Contact the local Medtronic Field Representative for questions. |
| Quantity | 420 units |
| Distribution | US: NY, OH, IL, NJ, MI, TN, WI, Australia, and Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K790565 | AORTIC ROOT CANNULA Dlp, Inc., Jun 11, 1979 |