Boston Scientific recalls Habib EUS RFA 20mm electrode active tips (Material Number 6700) 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 20mm electrode active tips (Material Number 6700) because they can cause thermal injury to tissue outside the 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 heat buildup outside the intended treatment area. This thermal injury may occur without medical intervention, potentially harming tissue beyond the target site.
Healthcare professionals using the Habib EUS RFA device for tissue ablation are most at risk. Patients receiving treatment with these devices may experience thermal injury if the device is used improperly.
Check for Material Number/UPN 6700 on the Habib EUS RFA 20mm electrode active tip. Affected units include batches 17-C01 through 17-C09 with specific expiration dates listed in the recall notice.
Identify the Material Number/UPN on the electrode tip; affected units have Material Number 6700.
The recall affects Habib EUS RFA 20mm electrode active tips with Material Number/UPN 6700.
Batches 17-C01 through 17-C09 with specific expiration dates 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-0668-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0668-2020 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.
