CanadaHarmony Delivery Catheter System (model HARMONY‑DCS), identifiable by lot or serial numbers consisting of more than 10 numbers, is affected. Two complaints reported distal tip detachment during implant; a root cause investigation found that, due to a manufacturing issue, specific manufacturing lots may have an increased potential for distal tip detachment under certain procedural or anatomical conditions. Contact the manufacturer, Medtronic Inc., for additional information.
What's being recalled
Companies: Medtronic Inc., 710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States, 55432.
How to identify it
Affected products: Harmony™ Delivery Catheter System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: HARMONY-DCS
The hazard
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 to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)