Use cautionMedical device recall · FDA · Published September 16, 2020
Boston Scientific Hurricane RX Biliary Balloon Catheters May Detach Due to Weak Bond
Boston Scientific recalls Hurricane RX Biliary Balloon Dilatation Catheters with specific model numbers and batch dates due to risk of the black sheath detaching from the catheter shaft.
“Boston Scientific Hurricane RX Biliary Balloon Catheters May Detach Due to Weak Bond.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64279-boston-scientific-hurricane-rx-biliary-balloon-catheters-may-detach-due. Based on FDA recall #Z-0286-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0286-2021%22&limit=1).
The FDA announced on September 16, 2020, that Boston Scientific Corporation is recalling Hurricane RX Biliary Balloon Dilatation Catheters because the RX tunnel component may detach from the catheter shaft. The agency said this defect poses a risk to patients using the device. Owners should contact Boston Scientific for further instructions.
Distribution: Worldwide distribution including US Nationwide and International
The hazard
The FDA said the RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength. The device is a double lumen catheter with a balloon mounted at the distal tip used to exert radial force to dilate narrow duct segments.
Context
GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since June 1, 2017. Recent recalls include Boston Scientific Imager II Angiographic Catheters recalled on August 24, 2026, for tip fracture risk and Boston Scientific LUX-Dx Cardiac Monitor System recalled on August 6, 2026, for delayed AF burden alerts. Other recent recalls of similar products include Rocket 18Fg Seldinger Catheter with Safety Guard (November 7, 2025) and Medline Urethral Catheters (May 4, 2026).
How to tell if you have this one
Check the product's catalog reference numbers (M00545890 to M00545960) and batch dates listed in the recall notice. The devices have specific expiration dates ranging from February 2022 to June 2022.
Identify the catalog reference number and batch date on the device packaging or label.
Contact Manufacturer
Reach out to Boston Scientific for assistance with the recall process.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and International distribution.” 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 49 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0286-2021 (September 16, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0286-2021 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.