Z-1691-2015Class II

SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107

Name: Z-1691-2015 SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107
Creator: Biosense Webster, Inc.
Published: 2015-03-19
License: https://open.fda.gov/license/

Biosense Webster Inc / initiated 2015-03-19 / Terminated / root cause: design

FDA source

Biosense Webster, Inc. began a recall of SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107. Product Usage: The use of the SMART ABLATE Generator and all accessories... on 2015-03-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1691-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-19
Posted: 2015-05-28
Terminated: 2015-06-17
Recalling firm: Biosense Webster Inc
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.
Product code: OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
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.
Root cause tag: design
FDA root cause: Device Design
Action: Biosense Webster sent an Urgent Field Safety Notification Letter dated March 18, 2015 via FedEx to all their customers that received the affected SMARTABLATE Generator System. The letter informs the customers of the problems identified and the actions to be taken. Biosense Webster is taking precautionary safety measures of reinforcing the Warnings in the Instructions for Use (IFU) for the SMARTABLATE System Foot Pedal. Customers with questions related to the are instructed to contact their local Biosense Webster sales representative or call (866) 473-7823, Monday through Friday from 7:00AM to 8:00PM EST. Customers with questions related to the voluntary field removal certification form and its return, are instructed to contact Elie Ghattas Field Action Coordinator at (909) 839-7281.
Quantity in commerce: 115 units
Distribution: Worldwide Distribution - US Nationwide in the state of: CA, IL, KY, NJ, PA and the countries of: Czech Republic, Denmark, Finland, France, Germany, and Sweden.
Product codes and lots: SMARTABLATE System Serial No. G4C-0296, G4C-0297, G4C-0272, G4C-0262, G4C-0232, G4C-0090. System Serial No. G4C-0076, G4C-0195, G4C-0064, G4C-0047, G4C-0159, G4C-0187, G4C-0146, G4C-0140, G4C-0037, G4C-0131, G4C-0031, G0054.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1691-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1691-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-28

Product code OAE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)