ThermoCool SmartTouch Navigation Catheters — Class II medical device recall Z-0139-2015
Terminated recall by Biosense Webster, Inc., reported 2014-11-05, distributed nationwide. The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective
| Recall number | Z-0139-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biosense Webster, Inc., Irwindale, CA, United States |
| Recall initiated | 2014-10-19 |
| Classified | 2014-10-27 |
| Reported by FDA | 2014-11-05 |
| Terminated | 2015-10-06 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| Model numbers | D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603 |
Product
ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.
Reason for recall
The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0139-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.