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U.S. Department of Health and Human Services

Class 2 Device Recall Habib EUS RFA

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  Class 2 Device Recall Habib EUS RFA see related information
Date Initiated by Firm November 18, 2019
Create Date December 11, 2019
Recall Status1 Terminated 3 on June 25, 2020
Recall Number Z-0668-2020
Recall Event ID 84375
510(K)Number K161305  
Product Classification Electrode, electrosurgical - Product Code JOS
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.
Code Information 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)
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
300 Boston Scientific Way
Marlborough MA 01752-1291
For Additional Information Contact Nicole Pshon
763-494-1556
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action On November 18, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail stating: Urgent Medical Device Recall - Immediate Action Required HABIB" EUS RFA 6500 and 6700 Dear Materials Manager / Field Action Contact: Boston Scientific (BSC) is initiating a voluntary removal of all HABIB" EUS RFA devices that remain in distribution. BSC acquired EMcision in March 2018. EMcision was the manufacturer of the Habib EUS RFA devices subject to this recall. The EMcision UK entity is no longer operating, therefore BSC is initiating the action. BSC recently identified that these devices present a risk of energy transferring from the active tip to the introducer device which may result in thermal injury to tissue outside the intended treatment area. The most common injury anticipated is tissue damage requiring little or no medical intervention. There is a remote probability of tissue damage or perforation occurring as a result of this issue that may require medical intervention, however this has not been reported to date. There is no additional follow up recommended for patients treated with these devices beyond normal standard of care. This recall affects all UPNs and batches listed below. No other products or UPNs are impacted by this notification. Refer to the Reply Verification Form included with this notification package for the list of individual batches we have record of shipping to your facility. Use and distribution of any remaining unused product affected by this removal should cease immediately. UPN: 6500 GTIN: 5060271140725 Batches: 17-C02, 17-C06, 17-C07, 17-C08 UPN: 6700 GTIN: 5060271140596 Batches: 17-C01, 17-C03, 17-C04, 17-C05, 17-C09 If you identify any affected product within your inventory, please segregate the product immediately and return it to Boston Scientific in accordance with the enclosed instructions. If you are a distributor, please note that this removal is to the customer level. Please notify any
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JOS and Original Applicant = EMCISION LTD.
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