Abiomed, Inc.
22 Cherry Hill Dr, DANVERS, MA, US
Registered product codes
10 product codes
Recent MDR events
46,840 on file
- Temporary Non-Roller Type Left Heart Support Blood PumpJul 31, 2026Death1220648-2026-11086
- ImpellaJul 31, 2026Malfunction1220648-2026-11087
- ImpellaJul 31, 2026Malfunction1220648-2026-11088
- ImpellaJul 31, 2026Malfunction1220648-2026-11089
- ImpellaJul 31, 2026Death1220648-2026-11090
- ImpellaJul 31, 2026Injury1220648-2026-11091
- ImpellaJul 31, 2026Injury1220648-2026-11092
- ImpellaJul 31, 2026Malfunction1220648-2026-11093
- ImpellaJul 31, 2026Malfunction1220648-2026-11094
- ImpellaJul 31, 2026Malfunction1220648-2026-11095
Recalls
86 on file
- Open, ClassifiedJul 10, 2026
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
View FDA record ↗ - Open, ClassifiedJul 10, 2026
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
View FDA record ↗ - Open, ClassifiedJul 10, 2026
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
View FDA record ↗ - Open, ClassifiedJul 10, 2026
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
View FDA record ↗ - Open, ClassifiedJul 10, 2026
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
View FDA record ↗ - Open, ClassifiedJul 10, 2026
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
View FDA record ↗ - Open, ClassifiedJul 10, 2026
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
View FDA record ↗ - Open, ClassifiedJul 10, 2026
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
View FDA record ↗ - Open, ClassifiedJul 10, 2026
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
View FDA record ↗ - Open, ClassifiedJul 10, 2026
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
View FDA record ↗
Compliance history
Matched by FEI 1220648.
FDA inspections
2 on file
- Official Action Indicated (OAI)Aug 5, 2025
Compliance: Devices · Citations posted
- Official Action Indicated (OAI)Aug 5, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗- 21 CFR 803.50(a)(1)Aug 5, 2025
Report of Death or Serious Injury
- 21 CFR 806.10(a)(1)Aug 5, 2025
Report of risk to health
- 21 CFR 820.40(a)Aug 5, 2025
Document review, approval by designated individual
- 21 CFR 820.100(a)Aug 5, 2025
Lack of or inadequate procedures
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.