Boston Scientific Recalls Habib EUS RFA Electrode Tips Due to Thermal Injury Risk
Boston Scientific is recalling 139 Habib EUS RFA electrode tips because capacitive coupling may cause thermal injury to tissue outside the target area.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a risk of thermal injury to tissue, 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 139 units of the Habib EUS RFA, 10mm electrode active tip (Material Number/UPN: 6500). The affected batches are 17-C02, 17-C06, 17-C07, and 17-C08. The device is indicated for coagulation and ablation of soft tissue when used with a compatible radiofrequency generator.
The recall was initiated because 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 the device is 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, and Greece. Users should stop using the affected devices and contact Boston Scientific Corporation for further instructions.
The recalled product
- Product
- Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - 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
- 139
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 (3)
- 17-C06 (Expiration: 19-Feb-2021)
- 17-C07 (Expiration: 19-Feb-2021)
- 17-C08 (Expiration: 20-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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