Habib EUS RFA recall
Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of…
Why was Habib EUS RFA 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Material Number/UPN: 6700 GTIN: 5060271140596 Batches: 17-C01 (Expiration: 10-Jul-2020), 17-C03 (Expiration: 12-Nov-2020), 17-C04 (Expiration: 18-Feb-2021), 17-C05 (Expiration: 18-Feb-2021), 17-C09 (Expiration: 19-Feb-2021)
- 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…
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 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.
- Recall date
- December 18, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)