FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Reported: August 20, 2025 Initiated: June 25, 2025 #Z-2278-2025
Product Description
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Reason for Recall
The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 445 units
- Distribution
- US Nationwide.
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401. Recalled by Boston Scientific Corporation. Units affected: 445 units.
Why was this product recalled? ▼
The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 20, 2025. Severity: Moderate. Recall number: Z-2278-2025.
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