Percutaneous Radiofrequency Ablation Catheter And The Potential Risk Of Atrioesophageal Fistula
Summary Percutaneous radiofrequency ablation catheters are being recalled in Canada due to a risk of atrioesophageal fistula, a serious condition where an abnormal connection can form between the heart and esophagus during the procedure. This recall affects medical devices used in cardiac ablation procedures across Canada. The issue impacts patients who have received or may receive treatment with these catheters.
- Reason
- Medical devices
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DRUGS
- Recall date
- 2018-04-16
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DRUGS
Recall details on Nibble Recalls: https://trynibble.app/recalls/22805bc6-5cc5-44ab-9729-c4add2e7b335