Medtronic HVAD Monitor Data Cable, Product Number: 1575
- Company
- Heartware, Inc.
- Recall Initiated
- February 26, 2021
- Recall Number
- Z-1339-2021
- Quantity
- 1337 units (1110 US)
- Firm Location
- Miami Lakes, FL
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.
Distribution
Worldwide
Lot / Code Info
All lot codes
Root Cause
Device Design
Action Taken
The firm issued a Medical Device Notice to its consignees on 02/26/2021 by letter delivered via UPS 2-day delivery. The letter explained the issue and directed the physician to review the patient management recommendations on the frequency of of inspecting the HVAD Controller, HVAD Controller power cables, and HVAD Monitor data cables. For questions regarding this material, please contact your Medtronic Field Representative.