Recall Z-2482-2025 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Medtronic Perfusion Systems
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
| Date | Sep 3, 2025 (initiated Aug 6, 2025) |
| Status | Open, Classified |
| Reason | The catheters may not retain their shape. |
| Root cause | Process change control |
| Action | Medtronic Cardiac Surgery issued an Urgent Medical Device Recall notice to its consignees on 08/06/2025 via UPS 2nd day delivery. The notice explained the issue with the device, potential harms if used, and requested the following: Customer Actions: Medtronic requests that you take the following actions: " Review your inventory for listed product. " Immediately identify and quarantine all unused, listed product in your inventory. " " " Please share this notification with others in your organization as appropriate. If product listed above has been forwarded to another facility, please noti |
| Quantity | 25261 units |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K834039 | INFANT VENT CATHETER 12001 W/SIDE VENT Dlp, Inc., Jan 3, 1984 |