Abiomed has initiated a voluntary recall for certain Automated Impella Controllers (AICs) used in conjunction with its Impella catheters following reports of one death as of 12 August in relation to a capacitor failure with the controllers鈥� interface.
Abiomed sent customers a letter on 20 August advising the affected units be removed from use and quarantined, according to the US Food and Drug Administration鈥檚 (FDA)
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The company said that a certain number of its AICs, used to control its Impella catheters and monitor them for alarms, have a pump driver circuit assembly that 鈥渄oes not meet current specifications鈥�.
Abiomed鈥檚 Impella catheters provide temporary ventricular support to help a patient鈥檚 heart pump blood in a critical care setting.
According to Abiomed, the affected circuitry in question contains 25V-rated tantalum capacitors instead of 35V-rated tantalum capacitors, potentially resulting in decreased pump performance or pump stop triggering either an 鈥業mpella Failure鈥� or 鈥業mpella Stopped. Controller failure鈥� notification.
The company added that the highlighted errors may lead to an 鈥渁brupt pump stoppage鈥� or decreased performance of the AIC, potentially resulting in transient haemodynamic instability, loss of circulatory support, or death.
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By GlobalDataThe FDA鈥檚 Early Alert was issued as part of the US agency鈥檚 pilot, which centred on improving the timeliness of communications to the public around corrective actions being taken by companies with devices believed to be high-risk recalls.
The latest Early Alert from the FDA comes as the second in as many months. In June, the FDA flagged a separate potentially high-risk issue with Abiomed鈥檚 AICs, wherein they 鈥渕ay not detect鈥� an Impella pump when connected. As of 13 June, Abiomed has reported three deaths in relation to the issue and advised customers to restart the case on the console or should it persist.
Since being acquired by J&J for $16.6bn in 2022, Abiomed has been plagued by issues affecting its Impella product line. In late 2022, the company recalled its left-sided Impella pumps due to the risk of heart perforation during procedures. The issue was linked to 49 deaths and 129 injury reports. In June 2023, Abiomed鈥檚 Impella RP Flex pumps were recalled due to a higher-than-expected rate of blood clots.
The FDA hit Abiomed with a warning letter over its failure to report quality control issues with its Impella product line, scolding the company for a lack of premarket approval for monitoring software used with its Impella devices and delays to corrective actions despite an 鈥渦nacceptably elevated rate鈥� of complaints.
