Recall Z-0830-2025 ยท PYX Temporary Non-Roller Type Right Heart Support Blood Pump
Abiomed, Inc.
Impella RP Flex with SmartAssist; Product Number: 1000323;
| Date | Jan 15, 2025 (initiated Dec 12, 2024) |
| Status | Open, Classified |
| Reason | Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, t |
| Root cause | Under Investigation by firm |
| Action | On December 13, 2024, URGENT MEDICAL DEVICE CORRECTION (NOTIFICATION) letters were sent to customers. RECOMMENDATIONS: Product is not being removed and hospital inventory may continue to be used. It is recommended that users lower the pump flow level to P-2 and use imaging guidance when inserting, manipulating, or removing any guidewires, indwelling venous lines or devices to reduce the potential for interaction of the device tip with the pump inlet. If optical sensor damage occurs and Placement Signal Not Reliable (PSNR) alarm is displayed no additional actions are required. Hemodynamic supp |
| Quantity | 2,364 units |
| Distribution | Domestic: Nationwide Distribution International: Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.