Urgent Field Safety Notice For Dual Energy Thermocool Smarttouch S. Bi-directional Catheter By Biosense Webster, Inc. (diamond Bar)
Recall Summary Biosense Webster is issuing an urgent safety notice for Dual Energy THERMOCOOL SMARTTOUCH S. Bi-Directional Catheters distributed in Germany and the EU. The company classified this as a Class I recall, the most serious type, though the specific safety concern is not detailed in the notice title. This notice affects medical facilities and patients in Germany and EU countries who have or may receive this catheter device.
- Recalling firm
- Biosense Webster, Inc. (Diamond Bar)
- Product
- Dual Energy THERMOCOOL SMARTTOUCH S. Bi-Directional Catheter
- Reason
- Urgent Field Safety Notice for Dual Energy THERMOCOOL SMARTTOUCH S. Bi-Directional Catheter by Biosense Webster, Inc. (Diamond Bar)
- Classification
- Class I
- Category
- medical device recall
- Country
- Germany
- Agency
- BFARM
- Recall date
- 2026-04-02
- Status
- Ongoing
- Distribution
- Germany / EU
Official recall notice from BFARM
Recall details on Nibble Recalls: https://trynibble.app/recalls/5c662f04-b211-4179-b5b7-715fd5c5a611