PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: December 18, 2019 Initiated: November 18, 2019 #Z-0668-2020

Product Description

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.

Reason for Recall

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.

Details

Units Affected
179
Distribution
Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CO, CT, FL, NJ, NY, MA, MD, MN, TN, TX and countries of Canada, India, Australia, Great Britain, Greece, Spain.
Location
Marlborough, MA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Boston Scientific Corporation. Units affected: 179.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 18, 2019. Severity: Moderate. Recall number: Z-0668-2020.

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