ProductGuru Recalls

Official recall record

Impella RP Flex with SmartAssist; Product Number: 1000323;

US FDA — Medical Devices · 2024-12-12 · United StatesClass I
Issuing authority
US FDA — Medical Devices
Alert date
2024-12-12
Country of alert
United States
Alert level
Class I
Alert type
recall
Barcode (EAN/GTIN)
00813502012811
Brand on record
Abiomed, Inc.

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: US FDA — Medical Devices · United States · all filters

Same barcode in other registries

The same EAN appears in 2 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

Other recalls from this brand

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.