Recall Z-0927-2022— Medtronic Inc
Class I · Ongoing
Class I FDA medical device recall by Medtronic Inc, initiated 2022-03-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.. Reason: There is potential for the capsule bond to break during the procedure..
- Recalling firm
- Medtronic Inc
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2022-03-02
- Firm location
- Minneapolis, MN, United States
Product description
Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
Reason for recall
There is potential for the capsule bond to break during the procedure.
Data sourced from openFDA. This site is unofficial and independent of the FDA.