Stop using now Medical device recall · FDA · Published February 2, 2023

Boston Scientific Habib EndoHPB Catheter Recall: Risk of Thermal Injury from Excessive RF

Boston Scientific recalls Habib EndoHPB Bipolar RF Catheters due to potential thermal injury from excessive energy delivery. Affected units have specific model and lot numbers; stop using immediately to prevent tissue damage.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1397-2023Medical device Boston Scientific ›

Stop using this now

Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due to the potential for delivery of excessive energy leading to thermal injury or tissue damage. An inaccurate setting is currently provided in the HABIB EndoHPB Catheter's Instructions for Use ("IFU").

Take action

Contact the company

Recalling firmBoston Scientific Corporation100 Boston Scientific Way · Marlborough, MA 01752-1234

✎ GovInfoNow plain-language explainer

Boston Scientific is recalling Habib EndoHPB Bipolar RF Catheters that could cause thermal injury if used improperly. This recall is critical because the device's instructions may provide inaccurate settings, risking serious tissue damage during medical procedures. Read more at govinfonow.com/recall/58964-boston-scientific-habib-endohpb-catheter-recall-risk-of-thermal-injury.

Source Summary by GovInfoNow · govinfonow.com/recall/58964-boston-scientific-habib-endohpb-catheter-recall-risk-of-thermal-injury · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1397-2023

Cite this page

“Boston Scientific Habib EndoHPB Catheter Recall: Risk of Thermal Injury from Excessive RF.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58964-boston-scientific-habib-endohpb-catheter-recall-risk-of-thermal-injury. Based on FDA recall #Z-1397-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1397-2023%22&limit=1).

The FDA announced on Feb. 2, 2023, that Boston Scientific Corporation is recalling the Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F due to a potential for excessive energy delivery causing thermal injury or tissue damage. Owners should cease use of the catheter with the ERBE VIO3 Generator immediately.

How to tell if you have it

Brand: Boston Scientific
Product: Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm)
UPC: 08714729981909
Distribution: Worldwide, including US, Canada, and others

The hazard

The recall cites a potential for delivery of excessive energy leading to thermal injury or tissue damage. This risk stems from an inaccurate setting currently provided in the Habib EndoHPB Catheter's Instructions for Use.

Context

GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since June 1, 2017. Recent brand recalls include the Imager II Angiographic Catheters Recall (Aug. 24, 2026) for tip fracture risk and the LUX-Dx Cardiac Monitor System Recall (Aug. 6, 2026) for delayed AF burden alerts. Other recent recalls of similar products include Paradise Ultrasound Renal Denervation Catheter Recall (Jan. 29, 2026), I.T.S. DUL/UOL Systems Risk MRI Heating - Recall (Jan. 23, 2026), and I.T.S. GmbH FR.O.H. Calcaneus Repair System: MRI Safety Risk (Jan. 23, 2026).

How to tell if you have this one

Check for the Habib EndoHPB Bipolar RF Catheter 8F (2.7mm) model. All lots and all expiration dates are affected. The product is sold under the UPN code M00500070 and GTIN 8714729981909.

Brand
Boston Scientific
Product
Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which provides bipolar
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop Using Immediately
Cease using the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator to prevent thermal injury or tissue damage.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Costa Rica, Czech Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, Iceland, Iraq,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 3 months after the firm started it.

Feb 2, 2023Firm started the recall
Apr 18, 2023FDA classified it Class II
Apr 26, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/58964-boston-scientific-habib-endohpb-catheter-recall-risk-of-thermal-injury">Boston Scientific Habib EndoHPB Catheter Recall: Risk of Thermal Injury from Excessive RF (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1397-2023 (February 2, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1397-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.