Recall Z-1802-2024 ยท DXS Gauge, Pressure, Coronary, Cardiopulmonary Bypass
Medtronic Perfusion Systems
Medtronic Disposable Pressure Display Sets: a) DLP 114.3 cm (45 in), Model Number 61000; b) DLP 114.3 cm (45 in), Model Number 62000
| 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 | 1624 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113235 | PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS Medtronic, Inc., Dec 2, 2011 |