Devices

Early Alert on Abiomed Introducer Kits Due to Serious Injuries

FDA has issued an early alert regarding a potentially high-risk problem involving certain Abiomed catheter introducer kits used with the company’s Impella heart pump system, citing concerns about blood clot formation that could lead to serious vascular complications.

The agency said it is aware that Abiomed has advised customers to remove all affected 14 French Low Profile Introducer Kits from use and distribution while the issue is evaluated.

The affected products include two versions of the 14Fr Low Profile Introducer Kit for the Impella CP system and the 10th-generation Impella CP Set with SmartAssist, which is compatible only with those introducer kits.

According to the FDA, Abiomed identified a higher-than-expected rate of complaints involving blood clot formation during prolonged use of the introducer sheath. Clinicians may observe difficulty aspirating the sheath sidearm or valve, or may detect thrombus in the syringe, sidearm, or around the valve following removal of the Impella CP pump, the alert says.

The agency warned that clot formation within the sheath lumen or the space between the catheter and sheath could disrupt blood flow near the vascular access site. If a clot becomes dislodged during support, device manipulation, or removal, it could obstruct peripheral blood vessels and cause ischemia, potentially requiring urgent medical intervention to restore circulation.

As of 5/15, Abiomed had received reports of three serious injuries associated with the issue. No deaths have been reported.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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