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U.S. Department of Health and Human Services

Class 1 Device Recall Harmony Delivery Catheter System

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  Class 1 Device Recall Harmony Delivery Catheter System see related information
Date Initiated by Firm March 02, 2022
Date Posted April 18, 2022
Recall Status1 Open3, Classified
Recall Number Z-0927-2022
Recall Event ID 89754
PMA Number P200046 
Product Classification Pulmonary valve prosthesis percutaneously delivered - Product Code NPV
Product Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
Code Information HARMONY-DCS (GTIN: 00763000341367); Lot Numbers: 0010519040, 0010565921, 0010578123, 0010578126, 0010583884, 0010631963, 0010631969, 0010631971, 0010717000, 0010717001, 0010717002, 0010723188, 0010723189, 0010723190, 0010727345, 0010804938, 0010826589, (the following lots were added 4/22/2022) 0010826591, 0010826592, and 0010826593
Recalling Firm/
Manufacturer		 Medtronic Inc
710 Medtronic Pkwy Mailstop Ls245
Minneapolis MN 55432-5603
For Additional Information Contact Medtronic Customer Service
800-854-3570
Manufacturer Reason
for Recall		 There is potential for the capsule bond to break during the procedure.
FDA Determined
Cause 2		 Under Investigation by firm
Action Beginning 02-MAR-2022 Medtronic initiated communications of an Urgent Medical Device Notice letter via 2-day UPS delivery to consignees who have received affected product according to Medtronic records. Consignees are asked to review the Medtronic Urgent Medical Device Notice notification and follow the Recommended Actions. Implanting physicians associated with related valves to the Harmony DCS were included in notifications, though these valve products are not subject to the recall issue. Additional verbal communication was initiated for a full product recall on March 24. Written communications were mailed on April 5, 2022 stating that Medtronic is recommending an immediate suspension of the Harmony DCS product use and is undertaking a voluntarily recall of the Harmony DCS.
Quantity in Commerce 1483 devices
Distribution US Nationwide and the countries of Canada.
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 = NPV and Original Applicant = Medtronic, Inc.
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