Recall Z-1341-2021— Heartware, Inc.
Class I · Ongoing
Class I FDA medical device recall by Heartware, Inc., initiated 2021-02-26. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: 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..
- Recalling firm
- Heartware, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2021-02-26
- Firm location
- Miami Lakes, FL, United States
Product description
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.