IMPELLA CP
Report
- Report Number
- 1220648-2025-49334
- Event Type
- Injury
- Date Received
- December 24, 2025
- Date of Event
- August 8, 2025
- Manufacturer
- ABIOMED, INC.
- Product Code
- OZD
- UDI-DI
- 00813502011876
- PMA / PMN Number
- P140003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H6 COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS CODES HAVE BEEN UPDATED TO REFLECT INVESTIGATION CLOSURE. INVESTIGATION SUMMARY: NO PRODUCT RETURNED. ASAE/HEMATOMA: LOQI REPORTED THAT LEFT FEMORAL ARTERY ACCESS SITE HEMATOMA. THE CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT: DEVICE LOT: 1943229. DEVICE HISTORY REVIEW: THIS PUMP (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS
A5 IS UNKNOWN. THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER. THEREFORE, THE INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.
A NOTIFICATION RECEIVED VIA ABIOMED¿S LONG-TERM OUTCOME AND QUALITY INDICATOR (LOQI) IMPELLA REGISTRY NOTED A PATIENT EXPERIENCED A LEFT FEMORAL ARTERY ACCESS SITE HEMATOMA. IT WAS STATED THAT THE LEFT GROIN HAD A SMALL HEMATOMA BUT WAS STABLE, RIGHT GROIN NO HEMATOMA. THE RELATIONSHIP WAS LISTED AS POSSIBLY RELATED TO IMPELLA USE. PATIENT OUTCOME WAS NOTED TO BE STABLE. ADDITIONAL INFORMATION WAS NOT AVAILABLE IN THE COMPLAINT RECORD ACCESSIBLE FOR MDR ASSESSMENT AT TIME OF REPORTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2477055 | IMPELLA CP | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. | IMPELLA CP | 2026698585 | 00813502011876 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Male | Other |