Z-0667-2020Class II

Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 -

Name: Z-0667-2020 Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 -
Creator: Boston Scientific Corporation
Published: 2019-11-18
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2019-11-18 / Terminated / root cause: design

FDA source

Boston Scientific Corporation began a recall of 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... on 2019-11-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0667-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-18
Posted: 2019-12-11
Terminated: 2020-06-25
Recalling firm: Boston Scientific Corporation
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.
Product code: JOS Electrode, Electrosurgical
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.
Root cause tag: design
FDA root cause: 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: 139
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.
Product codes and lots: Material Number/UPN: 6500 GTIN: 5060271140725 Batches: 17-C02 (Expiration: 9-Jul-2020), 17-C06 (Expiration: 19-Feb-2021), 17-C07 (Expiration: 19-Feb-2021), 17-C08 (Expiration: 20-Feb-2021)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0667-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0667-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-18	2019-12-11
Z-0668-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-18	2019-12-11

Product code JOS

K161305Class IIHabib EUS RFAEmcision , Ltd. / cleared 2016-07-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)