Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation Syst
Summary
The FDA issued a Class I for Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary V by Medtronic Inc. Reason: There is potential for the capsule bond to break during the procedure..
Details
Source
Device Recall
External ID
Z-0927-2022
Action Date
2022-04-27
Status
Ongoing
Category
device
Product Description
Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
Lot/Code Info: 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
Quantity Affected: 1483 devices
Reason for Recall
There is potential for the capsule bond to break during the procedure.
Distribution
US Nationwide and the countries of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-02
Company
Minneapolis, MN
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 150 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic Inc has 83 FDA actions in our database, including 46 recalls and 37 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Inc have FDA actions?
Medtronic Inc has 83 FDA actions in our database, including 46 recalls and 37 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0927-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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