| Class 1 Device Recall Medtronic HVAD Packaged Monitor | |
Date Initiated by Firm | February 26, 2021 |
Create Date | April 06, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1341-2021 |
Recall Event ID |
87446 |
PMA Number | P100047 |
Product Classification |
Ventricular (assist) bypass - Product Code DSQ
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Product | Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511BR, 1511CA, 1511CH, 1511DE, 1511GB, 1511IL, 1511IN, 1511IT, 1511JP, 1511MY, 1520CLIN-AU, 1520CLIN-DE, 1520CLIN-GB, 1520JP, 1520US, 1521AU, 1521BR, 1521CA, 1521CH, 1521DE, 1521GB, 1521IL, 1521IN, 1521IT, 1521JP, 1521KR, 1521TW, 1521US, 1522CA, 1522CA-CLIN |
Code Information |
All lot codes |
Recalling Firm/ Manufacturer |
Heartware, Inc. 14400 Nw 60th Ave Miami Lakes FL 33014-2807
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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 | 3283 devices (1824 US) |
Distribution | Worldwide |
Total Product Life Cycle | TPLC Device Report |
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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.
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PMA Database | PMAs with Product Code = DSQ
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