FDANovember 19, 2020device
Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1102, g. Model 1104CA-CLIN, h. Model 1205, i. Model MCS1705PU
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start, restart, or experiencing a delay in restart within the maximum number of restart attempts at a rate substantially higher than pump in the overall population.
What to do
FDA enforcement status: Ongoing
Brands named
heartware
UPCs
008887070032610088870700263900888707000017
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDA1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN2023-10-31
- FDAPUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 11042023-10-31
- FDAHVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 12052023-10-31
- FDAPUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 11032023-10-31
- FDAHVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 11002023-10-31
- FDAHVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 11022023-10-31
- FDASTERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 11012023-10-31
- FDAPUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP2023-10-31
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