FDA Adverse Event Malfunction Summary report: N

IMPELLA

MDR report key: 25027615 · Received April 29, 2026

Report

Report Number: 1220648-2026-07203
Event Type: Malfunction
Date Received: April 29, 2026
Date of Event: April 22, 2026
Manufacturer: ABIOMED, INC. - 1220648
Product Code: OZD
UDI-DI: 00813502012828
PMA / PMN Number: P140003
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE DEVICE WAS DISCARDED. THIS IS ONE OF TWO RELATED REPORTS. THIS REPORT REPRESENTS THE IMPELLA 5.5 AND ANOTHER REPORT WILL BE SUBMITTED TO REPRESENT THE IMPELLA CP. 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.

Description of Event or Problem · 0

THE COMPLAINANT REPORTED THAT A PATIENT WAS ESCALATED FROM AN IMPELLA CP TO IMPELLA 5.5. NUMEROUS ATTEMPTS WERE MADE TO PASS THE CATHETER THROUGH THE AXILLARY ARTERY, BUT ALL WERE UNSUCCESSFUL. IT APPEARED THAT THE PATIENT HAD A NARROW STRICTURE WHEN THE MEDICAL DOCTOR EXAMINED THE ARTERY UNDER FLUOROSCOPY. AFTER ABOUT 90 MINUTES, ATTEMPTS WERE ABORTED AND THE MEDICAL DOCTOR DECIDED TO USE THE IMPELLA CP IN THE AXILLARY INSTEAD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
586951	IMPELLA	TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP	OZD	ABIOMED, INC. - 1220648		2026785153	00813502012828

Patients

Seq	Age	Sex	Outcome	Treatment
1