Abiomed, Inc.: Device Recall

Recall #Z-0829-2025 · 12/12/2024

Class I: Dangerous

Recall Details

Recall Number
Z-0829-2025
Classification
Class I
Product Type
Device
Recalling Firm
Abiomed, Inc.
Status
Ongoing
Date Initiated
12/12/2024
Location
Danvers, MA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,560 units

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.

Product Description

Impella RP with SmartAssist; Product Number: 0046-0035;

Distribution Pattern

Domestic: Nationwide Distribution International: Canada

Other Recalls by Abiomed, Inc.

View all recalls by Abiomed, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.