Boston Scientific recalls FARAWAVE 1.0 Pulsed Field Ablation Catheters with specific batch numbers due to potential cracks in electrode bands that could affect safety during medical procedures.
The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.
Boston Scientific is recalling FARAWAVE 1.0 Pulsed Field Ablation Catheters with certain batch numbers because manufacturing equipment may have caused cracks in the electrode bands. This could lead to improper function during medical procedures if the catheter is used.
Cracks in the electrode bands could cause the catheter to malfunction during medical procedures. This might lead to improper treatment or complications if the catheter is used without the cracks being fixed.
Medical professionals using the FARAWAVE 1.0 catheter for procedures are most at risk. Patients receiving these catheters during treatment may also be affected.
Check for batch numbers: 36543581, 36543644, 36543646, 36568553, 36572565, 36572568, 36572571, 36572576, 36578308, 36578314, 36579110, 36598352, 36598809, 36599402, 36600406, 36600543, 36600544, 36600545, 36600578. The catheter model is FARAWAVE 1.0 Pulsed Field Ablation Catheter.
Look for batch numbers listed: 36543581, 36543644, 36543646, 36568553, 36572565, 36572568, 36572571, 36572576, 36578308, 36578314, 36579110, 36598352, 36598809, 36599402, 36600406, 36600543, 36600544, 36600545, 36600578.
Batch numbers: 36543581, 36543644, 36543646, 36568553, 36572565, 36572568, 36572571, 36572576, 36578308, 36578314, 36579110, 36598352, 36598809, 36599402, 36600406, 36600543, 36600544, 36600545, 36600578.
The catheter may have cracks in the electrode bands due to manufacturing equipment used, which could affect safety during medical procedures.
Check the batch number to see if it's affected. If it is, contact Boston Scientific for further instructions.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2278-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2278-2025 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
