
Increased risk of air embolism prompts Abbott's Class I recall of Amplatzer delivery sheath.


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Abbott is reporting an increased risk of air embolism when the Amplatzer steerable delivery sheath is used to deliver the Amulet left atrial appendage occluder, the FDA announced.

Class I Recall of Abbott Amplatzer Delivery Sheath

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Abbott Amplatzer Delivery Sheath Class I Recall Due to Air Embolism Risk


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Recall of GE Healthcare TruSignal SpO2 sensors due to potential risks.


The malfunctioning SpO2 sensors may reduce defibrillation energy, expose patients to unintended voltage, or give inaccurate readings.

Class I Recall of GE Healthcare TruSignal SpO2 Sensors

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GE Healthcare TruSignal SpO2 Sensors Class I Recall Details



Abbott recalls HeartMate Touch System due to critical pump issue.


The HeartMate Touch Communication System (version 1.0.32) is being recalled because the pump may unexpectedly stop or start.

Abbott Recalls HeartMate Touch System

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Abbott Recalls HeartMate Touch System Due to Critical Pump Issue



Abiomed recalls Impella left-sided blood pumps due to serious health risks.


Abiomed says the pump catheter may perforate the wall of the left ventricle. Instructions for use have been updated to address the issue.

Abiomed Impella Left-Sided Blood Pumps Recalled

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Abiomed Recalls Impella Left-Sided Blood Pumps Due to Serious Health Risks
