Biosense Webster Recalls SMARTABLATE RF Generator Systems Due to Unintended Energy Delivery
Biosense Webster is recalling 115 SMARTABLATE RF Generator Systems because two complaints reported the device inadvertently delivered RF energy during procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that inadvertently delivered energy, posing a risk of harm to patients, but the source text does not report any resulting injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Biosense Webster, Inc. is recalling 115 units of the SMARTABLATE RF Generator System, including catalog numbers M490006, M490007, M4900106, and M4900107. The affected devices are identified by specific serial numbers listed in the recall notice. These systems are indicated for use in conventional intracardiac RF ablation procedures in combination with compatible therapeutic catheters.
The recall was initiated after Biosense Webster received two complaints reporting that the SMARTABLATE RF Generator inadvertently delivered RF energy during an RMT procedure. The recall covers units distributed worldwide, including nationwide distribution in the United States (California, Illinois, Kentucky, New Jersey, and Pennsylvania) and in the Czech Republic, Denmark, Finland, France, Germany, and Sweden.
Healthcare providers and facilities should stop using the affected SMARTABLATE RF Generator Systems immediately. Users should contact Biosense Webster for instructions on how to return or replace the devices. The recall is classified as Class II by the FDA.
The recalled product
- 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 p
- Manufacturer
- Biosense Webster, Inc.
- Affected units
- 115
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- 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.
Distribution
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