Recall Z-0830-2025— Abiomed, Inc.
Class I · Ongoing
Class I FDA medical device recall by Abiomed, Inc., initiated 2024-12-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Impella RP Flex with SmartAssist; Product Number: 1000323;. 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, temporary pump stop, or permanent pump stop..
- Recalling firm
- Abiomed, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-12-12
- Firm location
- Danvers, MA, United States
Product description
Impella RP Flex with SmartAssist; Product Number: 1000323;
Reason for recall
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, temporary pump stop, or permanent pump stop.
Data sourced from openFDA. This site is unofficial and independent of the FDA.