Medtronic HVAD Pump Implant Kits Recalled for Startup Failures
Heartware, Inc. is recalling 19,562 Medtronic HVAD Pump Implant Kits because they may fail to start or restart at a higher rate than expected.
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: The recall involves a critical medical device (ventricular assist device) with a functional defect that prevents the device from starting or restarting, which poses a significant risk of serious injury or death to patients dependent on the device.
Plain-English summary
Heartware, Inc. is recalling 19,562 units of Medtronic HVAD Pump Implant Kits. The affected products are labeled with various model numbers, including PUMP 1103, PUMP 1104, PUMP 1104JP, PUMP 1100, Model 1101, Model 1102, Model 1104CA-CLIN, Model 1205, and Model MCS1705PU.
The recall is due to a defect in the impellers used in these pumps. Pumps manufactured with impellers from a specific 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 pumps in the overall population.
The affected units were distributed worldwide and across the United States. Patients and healthcare providers should contact Heartware, Inc. or their medical device representative for instructions on how to proceed with the recall.
The recalled product
- Product
- 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
- Manufacturer
- Heartware, Inc.
- Affected units
- 19,562
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 1103: GTIN 00888707003261
- Serial Numbers HW40002
- HW40004
- HW40006
- HW40009
- HW40017
- HW40025
- HW40045
- HW40046
- HW40048
- HW40049
- HW40051
- HW40054
- HW40061
- HW40067
- HW40068
- HW40073
- HW40074
- HW40075
- HW40079
Distribution
Distributed nationwide across the United States.
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