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U.S. Department of Health and Human Services

Class 1 Device Recall Medtronic HVAD Battery

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  Class 1 Device Recall Medtronic HVAD Battery see related information
Date Initiated by Firm February 26, 2021
Create Date April 06, 2021
Recall Status1 Open3, Classified
Recall Number Z-1340-2021
Recall Event ID 87446
PMA Number P100047 
Product Classification Ventricular (assist) bypass - Product Code DSQ
Product Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE
Code Information All lot codes
Recalling Firm/
Manufacturer		 Heartware, Inc.
14400 Nw 60th Ave
Miami Lakes FL 33014-2807
For Additional Information Contact MCS Customer Service
877-367-4823
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action 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.
Quantity in Commerce 114,133 devices (66,613 US)
Distribution Worldwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = DSQ and Original Applicant = Medtronic
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