Impella controller purge blocked alarm may be delayed on older pumps
Abiomed is recalling Automated Impella Controllers because the Purge System Blocked alarm display could be delayed when using first generation Impella 5.5 pumps.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The rubric states an FDA Class I recall is never scored below 4, and this record carries a Class I classification with no reported deaths in the source.
Plain-English summary
The Automated Impella Controller (AIC) is being recalled, covering the packaged controller for Canada (product code 0042-0000-CA), the EU (0042-0000-EU) and the UK (0042-0000-UK). About 62 units were distributed internationally to Australia, Canada, France, Germany and Kuwait.
There is potential that the "Purge System Blocked" alarm display on the Automated Impella Controller could be delayed when using first generation Impella 5.5 pumps. The FDA has classified this recall as Class I, its most serious category.
All products with software version 8.2.2 through 8.5 are affected, across the GTINs and serial numbers listed in the FDA enforcement record.
Facilities can identify affected controllers by the product code and software version above, and may contact the recalling firm for further information.
The recalled product
- Product
- Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Produc
- Manufacturer
- Abiomed, Inc.
- Affected units
- 62
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)
- GTIN: 00813502011272
- Serial Numbers: IC2035
- IC9416. 2. Product Code: 0042-0000-EU
- GTIN: 00813502011289
- Serial Numbers: IC1677
- IC3049
- IC3099
- IC3102
- IC4358
- IC4329
- IC5774
- IC5757
- IC6580
- IC6581. 3. Product Code: 0042-0000-UK
- GTIN: 00813502011296
- Serial Numbers: IC2023
- IC1910
- IC2704
- IC3325
- IC3312. 4. Product Code: 0042-0000-US
Distribution
Distribution scope not specified by the agency.
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