Pulsed Field Ablation Catheter Recalled Due to Electrode Band Defects
Boston Scientific is recalling 445 FARAWAVE 1.0 Pulsed Field Ablation Catheter units nationwide due to potential cracks in electrode bands caused by manufacturing equipment.
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: This is an FDA Class II medical device recall with no reported illnesses or injuries. The manufacturing defect affects electrode bands on a cardiac ablation catheter, creating potential risk of device malfunction during procedures. Per the rubric, Class II recalls without reported hospitalization warrant a score of 3.
Plain-English summary
Boston Scientific Corporation is recalling 445 units of the FARAWAVE 1.0 Pulsed Field Ablation Catheter (Product ID M004PF41M401) distributed nationwide. The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.
The FDA classifies this as a Class II recall. The electrode band defects could potentially affect device performance during patient procedures. No illnesses or injuries related to this defect have been reported to date.
Healthcare providers using affected units should immediately discontinue use of the recalled catheters. Patients with questions about their device should contact their healthcare provider. Verification of affected units can be performed using the UDI-DI (00191506043148) and batch numbers listed in the recall notice.
The recalled product
- Product
- FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
- Manufacturer
- Boston Scientific Corporation
- Hazard
- device-defect
- electrode-failure
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 (1)
- UDI-DI: 00191506043148
Distribution
Distributed nationwide across the United States.
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