Heart pump controllers recalled over potential operating system cybersecurity vulnerabilities
Abiomed is recalling 10,153 Automated Impella Controllers over potential cybersecurity vulnerabilities related to the controller's operating system.
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), used with the Impella left heart support blood pump, is being recalled. The action covers the packaged controller across regional product codes including 0042-0000-AU, 0042-0000-CA, 0042-0000-EU, 0042-0000-EU-L, 0042-0000-IN, 0042-0000-JP, 0042-0000-JP-L and 0042-0000-UK.
The recall concerns potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller.
The recall covers 10,153 units across all serial numbers, distributed nationwide in the United States and internationally to countries including the United Arab Emirates, Austria, Australia, Belgium and Brunei. The FDA has classified the recall as Class I.
Hospitals operating affected controllers should follow Abiomed's instructions for remediation.
The recalled product
- Product
- Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3.…
- Manufacturer
- Abiomed, Inc.
- Affected units
- 10,153
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: 0042-0000-AU
- GTIN: 813502010886
- All Serial Numbers. 2. Product Code: 0042-0000-CA
- GTIN: 813502011272
- All Serial Numbers. 3. Product Code: 0042-0000-EU
- GTIN: 813502011289
- All Serial Numbers. 4. Product Code: 0042-0000-EU-L
- All Serial Numbers. 5. Product Code: 0042-0000-IN
- GTIN: 813502011418
- All Serial Numbers. 6. Product Code: 0042-0000-JP
- GTIN: 813502010428
- All Serial Numbers. 7. Product Code: 0042-0000-JP-L
- All Serial Numbers. 8. Product Code: 0042-0000-UK
- GTIN: 813502011296
- All Serial Numbers. 9. Product Code: 0042-0000-UK-L
- All Serial Numbers. 10. Product Code: 0042-0000-US
- GTIN: 813502010022
- All Serial Numbers. 11. Product Code: 0042-0000-US-L
- All Serial Numbers. 12. Product Code: 0042-0010-AU
- GTIN: 813502010930
Distribution
Distributed nationwide across the United States.
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