HeartWare HVAD Pump Implant Kit recalled for welding defect risk
Medtronic is recalling HeartWare HVAD Pump Implant Kit units due to a welding defect in the center post cap that can lead to pump malfunction and affect blood flow.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity of 4 per the rubric. No reported injuries or fatalities are documented in the source, but the defect poses direct risk to critical cardiac function.
Plain-English summary
Medtronic Inc is recalling the HeartWare HVAD Pump Implant Kit, model numbers 1104JP and MCS1705PU. A total of 21 pump implant kits are affected by this recall.
The pump may contain a welding defect on the center post cap. This defect can allow moisture to enter the center post and corrode the magnets responsible for keeping the impeller rotating properly. If the magnets corrode, the impeller may make unintended contact with the center post, which could affect blood flow through the pump. Clinical signs and symptoms may resemble pump thrombosis.
The affected devices were distributed worldwide, including the United States (Delaware and Texas), Germany, and Japan. Patients and healthcare providers who have received these devices should contact Medtronic for further instructions regarding this recall.
The recalled product
- Product
- HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
- Manufacturer
- Medtronic Inc
- Hazard
- welding-defect
- moisture-intrusion
- pump-malfunction
- blood-flow-impairment
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) Model Number 1104JP: GTIN: 00763000170967 Serial numbers: HW41784
- HW41825
- HW41829
- HW41849
- HW41852
- HW41853
- HW41863
- HW42312
- HW42352
- HW42775
- HW42818
- HW42879
- HW42882
- and HW42884. b) Model Number MCS1705PU: GTIN 00888707005364
- Serial Numbers: HW42448 and HW42571
- GTIN 00888707007139
- Serial Numbers: HW42955 and HW42962
- GTIN 00888707009041
- Serial Numbers HW43483 and HW43484
- and GTIN 00888707003070
Distribution
Distributed nationwide across the United States.
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