U.S. FDA warning prompts Taiwan red alert over heart pump device

Taipei, Sept. 2 (CNA) Taiwan's Food and Drug Administration (TFDA) on Wednesday issued its highest-level consumer safety alert after U.S. regulators warned that a defect in a temporary heart pump system has been linked to three deaths and 37 serious injuries overseas.

The warning came after the U.S. Food and Drug Administration (FDA) issued an early notification on Aug. 26 that Abiomed Inc., a subsidiary of Johnson & Johnson, was recalling its Automated Impella Controllers (AICs) due to a cartridge recognition malfunction.

The defect could prevent the controller from confirming whether the cartridge was properly installed, potentially affecting the device's operation, the FDA said.

As of Aug. 17, Abiomed had reported 37 serious injuries and three deaths related to the issue, according to the FDA.

The Impella ventricular support system, described as the world's smallest heart pump, provides temporary circulatory support for patients with severe heart conditions, including cardiogenic shock, as well as those undergoing high-risk procedures such as percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG), TFDA Medical Devices and Cosmetics Division Director Chien Chia-hung (錢嘉宏) said.

Taiwan has one approved product license for the device, which is used by 19 medical institutions, Chien said. The affected products in Taiwan include 102 purge cassettes, 26 controllers and 97 introducers.

No patient injuries or adverse events related to the defect have been reported in Taiwan, Chien said, adding that the devices are used under close monitoring by medical professionals.

The TFDA has instructed the local license holder, Johnson & Johnson MedTech, to notify healthcare providers and implement the manufacturer's corrective measures, including replacing affected components, updating software and strengthening monitoring procedures.

The agency said it has monitored safety information on the product throughout the year and issued several notices on its website, although none previously involved a recall.

The TFDA's consumer safety alert system uses red, yellow and green levels. A red alert, the highest level, is issued when affected products are available in Taiwan and overseas incidents involve serious injuries or deaths, or when product defects could cause severe harm and require risk-control measures.