Public recall detail

Harmony™ Delivery Catheter System

2026-06-04

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Health products Health product recall
Quick summary

Quick summary: Harmony™ Delivery Catheter System. Reason: Health product recall. Category: Health products. Date: 2026-06-04.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Harmony™ Delivery Catheter System. Reason: Health product recall. Category: Health products. Date: 2026-06-04.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandMEDTRONIC INC
ProductHarmony™ Delivery Catheter System
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82164

Affected products

ProductHarmony™ Delivery Catheter System
LotMore than 10 numbers, contact manufacturer.
ModelHARMONY-DCS
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionHarmony™ Delivery Catheter System

Issue

Medtronic had received two (2) complaints about Harmony™ DCS distal tip detachment during the implant procedure. A root cause investigation has identified that, due to a manufacturing issue, Harmony™ DCS from specific manufacturing lots may have an increased potential for distal tip detachment under certain procedural or anatomical conditions.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular
CompaniesMedtronic Inc. 710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States, 55432
Recall date2026-05-28
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82164
Background{}
CompaniesMedtronic Inc. 710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States, 55432
AudiencesHealthcare
Source updated2026-06-04

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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