Medtronic HeartWare HVAD Battery Charger Recalled for Incorrect Inductors
Heartware, Inc. is recalling 2,031 HVAD System Battery Charger units because they were manufactured with incorrect inductors. The recall covers units distributed in the US and multiple international countries.
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 is classified as FDA Class II. The hazard involves a critical life-support medical device (HVAD System) where a manufacturing defect (incorrect inductors) poses a risk of harm, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Heartware, Inc. is recalling 2,031 units of the Medtronic HeartWare Ventricular Assist (HVAD) System Battery Charger, Model 1600US. The recall was initiated because the affected battery charger units were manufactured with incorrect inductors.
The HVAD System is indicated for use as a bridge to cardiac transplantation or as destination therapy for patients with refractory end-stage left ventricular heart failure. The battery charger is a critical component of the system, used to charge the batteries that power the pump controller. Patients are instructed to keep spare, fully charged batteries available for safe operation.
The affected units were distributed worldwide, including nationwide distribution in the United States and in countries such as Australia, Canada, Germany, and the United Kingdom. Consumers and healthcare providers should check their battery charger serial numbers against the list of affected codes provided in the official recall notice and contact Heartware, Inc. for further instructions.
The recalled product
- Product
- Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System (HVAD) is indicated in the United States (US) and European Union (EU) for use as a bridge to cardiac transplantation (BTT) as well as an altern
- Manufacturer
- Heartware, Inc.
- Affected units
- 2,031
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)
- BCH000403
- BCH000405
- BCH000406
- BCH000415
- BCH000420
- BCH000422
- BCH000423
- BCH000426
- BCH000428
- BCH000433
- BCH000435
- BCH000440
- BCH000442
- BCH000446
- BCH000451
- BCH000456
- BCH000459
- BCH000464
- BCH000465
- BCH000470
Distribution
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