WEBSTER HIS Catheter — Class II medical device recall Z-1525-2015
Terminated recall by Biosense Webster, Inc., reported 2015-05-06, distributed nationwide. The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 navigation Sy
| Recall number | Z-1525-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biosense Webster, Inc., Irwindale, CA, United States |
| Recall initiated | 2015-04-17 |
| Classified | 2015-04-27 |
| Reported by FDA | 2015-05-06 |
| Terminated | 2015-12-10 |
| Distributed | Nationwide (US) |
| Quantity | 503 units |
| Lot numbers | 17142745M, 17142888M, 17144954M, 17145731M, 17146665M, 17147443M, 17151134M, 17153400M, 17154141M, 17154595M, 17157116M, 17158235M, 17159129M, 17159407M, 17162927M, 17163734M, 17167282M, 17167809M, 17172058M, 17172465M, 17173428M, 17174967M, 17174968M, 17176185M, 17176186M, 17176477M, 17176478M, 17177237M, 17177957M, 17191133M, 17192170M, 17192723M, 17194186M, 17194707M, 17196045M |
| Model numbers | 01085413 |
Product
WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure; i.e., stimulation and recording only. Catalog No: 01085413
Reason for recall
The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 navigation System.
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-1525-2015. 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.