Impella controllers recalled over purge pressure issues from retainer failures
Abiomed is recalling Automated Impella Controllers over the potential for purge pressure issues caused by purge retainer failures, covering 9,177 distributed units.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the Critical tier.
Plain-English summary
The Automated Impella Controller (AIC) is being recalled across several configurations, including AIC with Impella Connect for ECP (product code 1000432) and the double optical AIC Impella Connect (product code 1000201).
The recall concerns the potential for Automated Impella Controller purge pressure issues due to purge retainer failures.
The enforcement record lists 9,177 total distributed units, of which 754 were pending correction. Distribution was worldwide, including nationwide in the United States and to Australia, Austria, Belgium, Brazil, Canada, Colombia, Croatia and Czechia. The FDA has classified the recall as Class I.
Hospitals operating affected controllers should follow Abiomed's instructions.
The recalled product
- Product
- Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 1000432. 2. Dbl optical, AIC Impella Connect, Phg US, Product Code: 1000201. 3. Impella Controller, Packaged, AU, Product Code…
- Manufacturer
- Abiomed, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1. Product Code: 1000432
- GTIN: 00813502013030
- Serial Numbers pending correction as of 09/16/2025: IC11239
- IC11238
- IC10837
- IC10497
- IC10493
- IC10338
- IC10362. Serial Numbers corrected as of 09/16/2025: IC11404
- IC11401
- IC11400
- IC11399
- IC10827
- IC11237
- IC11236
- IC11232
- IC11231
- IC11230
- IC11227
- IC11210
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Abiomed, Inc.
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