Tactiflex™ Ablation Catheter, Sensor Enabled™
TactiFlex™ Ablation Catheter, Sensor Enabled™ Recall Summary The TactiFlex™ Ablation Catheter, Sensor Enabled™ is being recalled across Canada due to labelling and packaging issues that affect how the device performs. This is a Class I recall, which indicates a serious problem. The recall affects all units of this catheter that were distributed in Canada.
- Product
- TactiFlex™ Ablation Catheter, Sensor Enabled™
- Reason
- Labelling and packaging - Performance
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2025-09-17
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/6c6bbb46-717f-40cb-902c-9a60b62dd0a5