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Impella RP Flex with SmartAssist (Abiomed) – Optical Sensor Damage (2024)

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.

Moderate

FDADec 12, 2024Nationwide• Abiomed, Inc.

EOPA Arterial Cannula (Medtronic) – Incorrect Labeling (2024)

Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.

Low

FDA

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Impella RP Flex with SmartAssist (Abiomed) – Optical Sensor Damage (2024)

EOPA Arterial Cannula (Medtronic) – Incorrect Labeling (2024)

Select Series Arterial Cannula (Medtronic) – Incorrect Labeling (2024)

VISIONIST CRT-P (Boston Scientific) – Safety Mode Potential (2024)

SenTiva Microburst VNS Generator (LivaNova) – Stimulation Interruption Risk (2024)

ALTRUA 2 DR Pacemaker (Boston Scientific) – Safety Mode Potential (2024)

VALITUDE CRT-P (Boston Scientific) – Safety Mode Potential (2024)

DLP Pediatric Arterial Cannulae (Medtronic) – Incorrect Labeling (2024)

ACCOLADE DR Pacemaker (Boston Scientific) – Safety Mode Potential (2024)

Impella RP with SmartAssist (Abiomed) – Optical Sensor Damage (2024)

HealthFirst Mail-In Monitoring System (HF Acquisition) – Envelope Printing Error (2024)

LVIS Intraluminal Support Device (MicroVention) – Stent Deployment Issue (2024)

Medtronic NanoCross Elite PTA Catheter (Unknown) – Balloon Deflation Issue (2024)

EMPOWR 3D Knee Tibial Insert (Unknown) – Surgical Kit Mismatch (2024)

Neo-Tee T-Piece Resuscitator (Mercury Medical) – Flow Controller Defect (2024)

Idylla Instrument (Biocartis) – False-Positive MSI-H Results (2024)

JMC5A Oxygen Concentrator (Jiangsu Jumao) – Fire Hazard Risk (2024)

VasoView Hemopro 2 with Vasoshield (Maquet) – Multiple Component Risks (2024)

VasoView HemoPro 2 Vessel Harvesting System (Maquet) – Multiple Component Risks (2024)

Ivenix Infusion System (Fresenius Kabi) – Pneumatic Valve Failure (2024)