Reported Jan 22, 2025 · Ongoing
Impella RP with SmartAssist; Product Number: 0046-0035;
Abiomed, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abiomed, Inc. · 24 Cherry Hill Dr · Danvers, MA · 01923-2575
Is this the product you have?
- Impella RP with SmartAssist
- Product Number0046-0035
- Lot codes and dates
- Product Number0046-0035
- UDI-DI00813502011869
- Serial Numbers
1,560 of 1,560 codes
492884492882492883522056522054522055522106522107522110522111522105522109520014520017520018520019520020520021520022520023520747520748520743520744520746520739520740520664520742520660520661520663520666520668518497520659520665518500518501518496518494518499518502518503518963518960518961518962518959518958518955518956507392518954507386507389507390507391507385507384
- Amount recalled
- 1,560 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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