SMARTABLATE RF Generator System — Class II medical device recall Z-1691-2015
Terminated recall by Biosense Webster, Inc., reported 2015-06-03, distributed nationwide. Biosense Webster is recalling the SMARTABLATE Generator System because Biosense Webster has received two compl
| Recall number | Z-1691-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biosense Webster, Inc., Irwindale, CA, United States |
| Recall initiated | 2015-03-19 |
| Classified | 2015-05-28 |
| Reported by FDA | 2015-06-03 |
| Terminated | 2015-06-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | CZ, DE, DK, FI, FR, SE |
| Quantity | 115 units |
| Serial numbers | G0054, G4C-0031, G4C-0037, G4C-0047, G4C-0064, G4C-0076, G4C-0090, G4C-0131, G4C-0140, G4C-0146, G4C-0159, G4C-0187, G4C-0195, G4C-0232, G4C-0262, G4C-0272, G4C-0296, G4C-0297 |
| Model numbers | M490006, M490007, M4900106, M4900107 |
Product
SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107. Product Usage: The use of the SMART ABLATE Generator and all accessories is indicated in combination with compatible therapeutic catheters for use in conventional intracardiac RF ablation procedures. The SMARTABLATE Foot Pedal is designed to initiate or discontinue operation of the SMARTABLATE System. The Foot Pedal can be connected to the SMARTABLATE RF Generator, SMARTABLATE Irrigation Pump; or SMARTABLATE Remote Control.
Reason for recall
Biosense Webster is recalling the SMARTABLATE Generator System because Biosense Webster has received two complaints reporting that during an RMT procedure the SMARTABLATE RF Generator inadvertently delivered RF energy.
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-1691-2015. 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.