The Recall Desk
SevereFDA (Devices)·Z-0927-2022·Announced 2022-04-27

Medtronic Harmony Delivery Catheter System Recalled Over Equipment Failure Risk

Medtronic is recalling 1,483 Harmony Delivery Catheter Systems due to potential capsule bond failure during pulmonary valve replacement procedures. The FDA has classified this as a Class I recall affecting devices distributed in the US and Canada.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This device recall has been classified as FDA Class I, the most serious FDA category. Under the severity rubric, FDA Class I recalls require a minimum severity score of 4. While no deaths or reported injuries are documented in the source, the Class I designation reflects the serious nature of a potential equipment failure during a cardiac procedure.

Plain-English summary

Medtronic Inc is recalling the Harmony Delivery Catheter System, which is part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System. The recall affects 1,483 devices distributed nationwide in the United States and in Canada.

The FDA has classified this as a Class I recall. The hazard involves a potential defect in which the capsule bond may break during the procedure. If this occurs, it could affect the proper delivery and placement of the valve replacement implant.

Healthcare providers who have received any of the affected lot numbers should immediately stop using the devices and contact Medtronic. Patients who have received this device, or who are scheduled for a procedure using this system, should speak with their healthcare provider about the recall.

The recalled product

Product
Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
Manufacturer
Medtronic Inc
Category
Medical Device — Cardiac / Valve Replacement
Hazard
Affected units
1,483

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

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