FDA Adverse Event Death Summary report: N

ARROW TELEFLEX AC3 SERIES IABP

MDR report key: 24364001 · Received February 17, 2026

Report

Report Number
MW5183867
Event Type
Death
Date Received
February 17, 2026
Date of Event
December 30, 2025
Report Date
February 10, 2026
Manufacturer
ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORATED)
Product Code
DSP
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
NURSE
Health Professional
Yes

Narratives

Description of Event or Problem · 0

75-YEAR-OLD FEMALE WITH INTRA-AORTIC BALLOON PUMP (IABP) HAD SUSPECTED BALLOON RUPTURE ON (B)(6) 2025 AT 18:10, REQUIRING IMMEDIATE IAB REMOVAL AT BEDSIDE. AFTER DISCUSSIONS WITH FAMILY, THE PATIENT WAS TRANSITIONED TO COMFORT CARE AND TIME OF DEATH WAS PRONOUNCED AT 23:46. HISTORY OF LIVING-DONOR KIDNEY TRANSPLANT ON CHRONIC IMMUNOSUPPRESSION, PERIPHERAL ARTERY DISEASE, HYPERLIPIDEMIA, DIABETES MELLITUS, AND RECENT LEFT LOWER EXTREMITY DVT, WHO WAS ADMITTED ON (B)(6) 2025 WITH ACUTE HYPOXEMIC RESPIRATORY FAILURE AND CARDIOGENIC SHOCK DUE TO A FLAIL MITRAL VALVE LEAFLET. ON (B)(6) 2025, THE PATIENT REQUIRED ENDOTRACHEAL INTUBATION AND INTRA-AORTIC BALLOON PUMP (IABP) PLACEMENT FOR MECHANICAL CIRCULATORY SUPPORT. HER COURSE WAS COMPLICATED BY ACUTE RENAL FAILURE REQUIRING HEMODIALYSIS, PERSISTENT VASOPRESSOR DEPENDENCE, AND THROMBOCYTOPENIA TEMPORALLY ASSOCIATED WITH HEPARIN INITIATION FOR DVT TREATMENT, PROMPTING TRANSITION TO ARGATROBAN FOR POSSIBLE HEPARIN-INDUCED THROMBOCYTOPENIA. AT 18:10 ON (B)(6) 2025, IABP ALARMS INDICATED HIGH PRESSURE, PROMPTING URGENT EVALUATION AND IDENTIFICATION OF BALLOON RUPTURE. THE DEVICE WAS IMMEDIATELY REMOVED AT THE BEDSIDE WITH CARDIOLOGY AND VASCULAR SURGERY ASSISTANCE. THE PATIENT REQUIRED TRANSIENT ESCALATION OF VASOPRESSORS DURING REMOVAL DUE TO BLOOD LOSS BUT STABILIZED AFTERWARD. FAMILY NOTIFIED AND ELECTED NOT TO TRANSFUSE GIVEN THE FAMILY'S PLAN TO TRANSITION TO COMFORT CARE ON (B)(6) 2026. FAMILY WAS AWARE THAT PATIENT WOULD PASS IMMINENTLY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
423726 ARROW TELEFLEX AC3 SERIES IABP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORATED)

Patients

Seq Age Sex Outcome Treatment
1 75 YR Female Life Threatening| D