Class II — Biosense Webster, Inc.
| Recalling firm | BIOSENSE WEBSTER, INC. |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter. |
| Product | ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603. |
| Quantity | 173,329 units total (21,812 units in US) |
| Distribution | Nationwide Distribution |
| Initiated | 2014-10-19 |
| Classified | 2014-10-27 |
| Terminated | 2015-10-06 |
| Recall number | Z-0139-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Biosense Webster, Inc. (Z-0139-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69532/
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