FARAWAVE ablation catheters may have cracks in the distal electrode bands
FARAWAVE 1.0 Pulsed Field Ablation Catheters are being recalled because specific manufacturing equipment may have caused cracks in the electrode bands on the catheter's distal end. 445 units affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Risk-of-harm product: cracks in the electrode bands at the working end of a cardiac ablation catheter, with no injury reported in the source.
Plain-English summary
The FARAWAVE 1.0 Pulsed Field Ablation Catheter, product ID M004PF41M401, UDI-DI 00191506043148, is being recalled. The action covers 445 units across the batch numbers listed in the recall notice.
The stated reason is that 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 classified the action as Class II. The source does not report any injury having occurred.
Distribution was nationwide in the United States. The catheters are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the product ID, UDI-DI and batch numbers above, quarantine it, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 445
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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