IMPELLA 5.5
Report
- Report Number
- 1220648-2025-49373
- Event Type
- Injury
- Date Received
- December 24, 2025
- Date of Event
- October 1, 2025
- Report Date
- December 24, 2025
- Manufacturer
- ABIOMED, INC.
- Product Code
- OZD
- UDI-DI
- 00813502013276
- PMA / PMN Number
- P140003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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 RETURN. INFECTION / POST-PROCEDURAL ADVERSE EVENT: CLINICAL DETAILS NOTE A WOUND HEALING DISORDER WITH PROVEN KLEBSIELLA OXCYTOCA. NO PRODUCT WAS RETURNED AND LOGS ARE NOT APPLICABLE. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT: DEVICE LOT : 1893944. DEVICE HISTORY BATCH: SUBCOMPONENT LOT : N/A. DEVICE HISTORY REVIEW: THE PUMP SN (B)(6) PASSED ALL THE POST STERILE INSPECTION CHECKS.
THE IMPELLA DEVICE HAS NOT BEEN RECEIVED FROM THE CUSTOMER. THEREFORE, INVESTIGATION OF THE DEVICE IS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. PATIENT INFORMATION UNKNOWN.
IT WAS REPORTED THAT THE PATIENT HAD A PRIOR WOUND HEALING DISORDER WITH PROVEN KLEBSIELLA OXCYTOCA. MEDICAL INTERVENTION AS WELL AS ANY MEDICATIONS GIVEN ARE UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1801607 | IMPELLA 5.5 | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. | IMPELLA 5.5 | 2026619794 | 00813502013276 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |