Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE
Reported: April 14, 2021 Initiated: February 26, 2021 #Z-1340-2021
Product Description
Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE
Reason for Recall
There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the Controller ports, due to wear from misalignment of the cables to the port.
Details
- Recalling Firm
- Heartware, Inc.
- Units Affected
- 114,133 devices (66,613 US)
- Distribution
- Worldwide
- Location
- Miami Lakes, FL
Frequently Asked Questions
What product was recalled? ▼
Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE. Recalled by Heartware, Inc.. Units affected: 114,133 devices (66,613 US).
Why was this product recalled? ▼
There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the Controller ports, due to wear from misalignment of the cables to the port.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 14, 2021. Severity: Critical. Recall number: Z-1340-2021.
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