Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
Reported: April 27, 2022 Initiated: March 2, 2022 #Z-0927-2022
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.
Details
- Recalling Firm
- Medtronic Inc
- Units Affected
- 1483 devices
- Distribution
- US Nationwide and the countries of Canada.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.. Recalled by Medtronic Inc. Units affected: 1483 devices.
Why was this product recalled? ▼
There is potential for the capsule bond to break during the procedure.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 27, 2022. Severity: Critical. Recall number: Z-0927-2022.
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