Abiomed recalled 9,177 distributed Automated Impella Controllers worldwide over purge pressure concerns linked to purge retainer failures. The recall covers multiple product codes, including AIC w/Impella Connect for ECP (1000432) and various packaged controllers. Hospitals and clinicians should stop using the device and follow the manufacturer's recall instructions immediately.
Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Abiomed, Inc. or your healthcare provider for instructions. Notification method: Letter
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The Impella Controller is used to guide and monitor the Impella heart pump system. It plays a critical role in certain cardiac support procedures.
A purge retainer failure can create purge pressure issues, potentially affecting device performance during use.
This recall is not identified as part of a broader industry pattern in the provided documentation.
Healthcare providers must halt use of these devices immediately. Patients may require reassessment and alternative support as determined by clinicians.
Refer to the recall notice and the FDA enforcement page for list of affected product codes and serial ranges
Remediation timelines are not specified. Expect communications from Abiomed and healthcare providers within weeks to months
Keep copies of all recall notices, letters, serial numbers, and correspondences with Abiomed or clinicians
Product: Automated Impella Controller (AIC) and variants. Product Codes include 1000432 (AIC w/Impella Connect for ECP) and 1000201 (Dbl optical, AIC Impella Connect). Packaged controllers include 0042-0000-US and other country codes (CA, EU, IN, JP, UK, AU). Optical AIC and Impella Connect packaging variants listed with codes 0042-0040-XX and 0042-0010-XX. Total distributed units: 9,177 worldwide (822 pending correction). Serial numbers include IC11619, IC11616, IC11611, IC11600, IC11239, IC11238, IC10837, IC10497, IC10493, IC10338, IC10362; corrected as of 09/16/2025: IC11404, IC11401, IC114
No injuries or incidents have been reported.
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