Impella
Received Jul 31, 2026 · Event occurred Jul 16, 2026
Report 1220648-2026-11094 · MDR key 50098265
Device
Generic name
Temporary Non-roller Type Left Heart Support Blood Pump
Manufacturer
Abiomed, Inc. - 1220648Catalog number
0042-0040-US
Lot number
1815751
Product problems
- Crack
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
The complainant reported damage to side of their Automated Impella Controller (AIC) during training. No patient harm has been reported.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 CFR, Part 803. This report may be based on information which has not been investigated or verified prior to the required reporting date. This report does not reflect a conclusion by Abiomed Inc, or its employees that the report constitutes an admission that the product, Abiomed Inc, or its employees caused or contributed to the potential event described in this report. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.