Harmony™ Delivery Catheter System
Brand(s)
Last updated
Summary
Product
Harmony™ Delivery Catheter System
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Harmony™ Delivery Catheter System | More than 10 numbers, contact manufacturer. | HARMONY-DCS |
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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Medtronic Inc.
710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States, 55432
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82164
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