Boston Scientific recalls Habib EUS RFA 10mm electrode active tips (Material Number 6500) due to risk of thermal injury from capacitive coupling with un-insulated needles. Affected units include specific batches with expiration dates.
During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling presents a risk of energy transfer from the Habib EUS RFA active tip to the introducer device. This capacitive coupling could result in thermal injury to tissue outside of the targeted treatment area due to its use with an un-insulated EUS-FNA needle requiring little or no medical intervention.
Boston Scientific is recalling Habib EUS RFA 10mm electrode active tips (Material Number 6500) because they can cause thermal injury to tissue outside the intended treatment area when used with un-insulated EUS-FNA needles. This risk occurs due to capacitive coupling that transfers energy without medical intervention.
The device can transfer energy to un-insulated EUS-FNA needles through capacitive coupling, causing thermal injury to tissue beyond the targeted treatment area. This injury may require medical intervention if not addressed promptly.
Medical professionals using the Habib EUS RFA device for tissue ablation are most at risk. Patients receiving the device for treatment may also be affected if the device is used improperly.
Check for Material Number/UPN 6500 on the device. Affected units include batches 17-C02 through 17-C08 with specific expiration dates listed in the recall notice.
Look for Material Number/UPN 6500 on the Habib EUS RFA 10mm electrode active tip.
The specific model number is Material Number/UPN 6500 for the Habib EUS RFA 10mm electrode active tip.
Batches 17-C02 through 17-C08 with expiration dates of 9-Jul-2020 to 20-Feb-2021 are affected.
The recall record does not specify a remedy.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0667-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0667-2020 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.
