Heartware HVAD Pump Implant Kit Recalled for Graft and Screw Defects
Heartware, Inc. is recalling 85 HVAD Pump Implant Kits because the outflow graft may tear or the strain relief screw may break during assembly.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm medical device where injury has not yet been reported, fitting the 'High' severity criteria for products with potential for harm but no confirmed adverse events.
Plain-English summary
Heartware, Inc. is recalling 85 units of the Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP. The recall covers units distributed worldwide with specific GTINs and serial numbers listed in the agency record.
The recall is due to a manufacturing defect where the Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump. This defect poses a risk of device failure during the surgical preparation process.
Healthcare providers and patients should contact Heartware, Inc. for further instructions regarding the affected units. The source text does not specify a particular consumer action beyond the recall notification, but medical professionals should verify if any of the listed serial numbers are in their inventory or patient records.
The recalled product
- Product
- Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP
- Manufacturer
- Heartware, Inc.
- Affected units
- 85
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)
- GTIN 00888707000697
- Serial numbers: HW34700
- HW34703
- HW34710
- HW34713 GTIN 00888707005838
- Serial Numbers: HW40383
- HW40412
- HW40413
- HW40414
- HW40415
- HW40417
- HW40418
- HW40419
- HW40420
- HW40421
- HW40422
- HW40423
- HW40424
- HW40425
- HW40426
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Heartware, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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