IMPELLA 5.5
Report
- Report Number
- 1220648-2025-48983
- Event Type
- Death
- Date Received
- December 12, 2025
- Date of Event
- November 14, 2025
- Report Date
- March 25, 2026
- Manufacturer
- ABIOMED, INC.
- Product Code
- OZD
- UDI-DI
- 00813502012828
- PMA / PMN Number
- P140003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
D4: CATALOG, SERIAL AND PRIMARY UDI NUMBER CORRECTED.
ADDITIONAL INFORMATION HAS BEEN PROVIDED IN H6 (HEALTH EFFECT-IMPACT CODE, HEALTH EFFECT- CLINICAL CODE, AND MEDICAL DEVICE PROBLEM CODE). 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.
THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER; THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.
D6B: ADDED EXPLANT DATE.
B2 REVISED SELECTION AS THE SELECTION ON THE INITIAL REPORT THAT WAS SUBMITTED WAS INCORRECT. E1 ADDED INITIAL REPORTER PHONE AND ZIP CODE EXTENSION AS THEY WERE OMITTED FROM THE INITIAL REPORT THAT WAS SUBMITTED. H6 REVISED MEDICAL DEVICE PROBLEM CODE SINCE THE INITIAL REPORT HAS BEEN SUBMITTED. H6 TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS AND COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. INVESTIGATION SUMMARY: THE INVESTIGATION HAS BEEN COMPLETED. PRODUCT AND DATA WERE NOT RETURNED FOR REVIEW. MECHANICAL INTERACTION WITH BLOOD: THE CAUSE OF MECHANICAL INTERACTION WITH BLOOD WAS UNABLE TO BE DETERMINED AS LIMITED CLINICAL DETAILS WERE PROVIDED AND NO PRODUCT WAS RETURNED FOR REVIEW. DEVICE HISTORY REVIEW: THE PUMP PASSED ALL POST STERILE INSPECTION CHECKS.
B5 UPDATED.
IT WAS REPORTED THAT A PATIENT HAD WORSENING HEART FAILURE SYMPTOMS AND IS NOW IN STAGE 3 HEART FAILURE WITH AN EJECTION FRACTION OF 20%. DUE TO MOST RECENT ADMISSION, HE WAS SCHEDULED FOR AN IMPELLA 5.5 PLACEMENT AND WILL BE LISTED FOR TRANSPLANT THE FOLLOWING DAY. DURING IMPELLA SUPPORT IT WAS REPORTED THAT THERE WERE SLIGHT CONCERNS FOR HEMOLYSIS AS LACTATE DEHYDROGENASE IS ~300S, PREVIOUS RESULT HEMOLYZED AND PLASMA FREE HEMOGLOBIN SPIKED TO 100 AND IS NOW DOWN TO 29. HEART FAILURE TEAM PLANS TO DO ECHO TODAY TO VERIFY PLACEMENT. THE PATIENT REMAINS ON SUPPORT.
THE COMPLAINANT REPORTED THE PATIENT HAD HIGH FEVER AND WHITE BLOOD CELL COUNT. SUCTION ALARMS AND PLACEMENT SIGNAL LOW ALARMS/IMPELLA POSITION UNKNOWN ALSO OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2710834 | IMPELLA 5.5 | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. | IMPELLA 5.5 | 2026747051 | 00813502012828 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Male | Required Intervention |