Boston Scientific Recalls Habib EUS RFA Electrode Tips Due to Thermal Injury Risk
Boston Scientific is recalling 179 Habib EUS RFA electrode tips because capacitive coupling may cause unintended thermal injury to tissue outside the treatment area.
What this means for you
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: The recall is classified as FDA Class II. The hazard involves a risk of thermal injury to tissue outside the targeted area, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Boston Scientific Corporation is recalling 179 units of the Habib EUS RFA, 20mm electrode active tip (Material Number/UPN: 6700). The device is indicated for coagulation and ablation of soft tissue when used with a compatible radiofrequency generator.
The recall was initiated after testing revealed a temperature increase at the tip of the EUS-FNA needle. It was determined that capacitive 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 when used with an un-insulated EUS-FNA needle.
The affected units were distributed worldwide, including in the United States (AL, AZ, CA, CO, CT, FL, NJ, NY, MA, MD, MN, TN, TX) and in Canada, India, Australia, Great Britain, Greece, and Spain. The specific batches involved are 17-C01, 17-C03, 17-C04, 17-C05, and 17-C09. Users should stop using the affected devices and contact Boston Scientific for further instructions.
The recalled product
- Product
- Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency generator.
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 179
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 (4)
- 17-C03 (Expiration: 12-Nov-2020)
- 17-C04 (Expiration: 18-Feb-2021)
- 17-C05 (Expiration: 18-Feb-2021)
- 17-C09 (Expiration: 19-Feb-2021)
Distribution
Part of a larger recall action
This product is one of 2 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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