Hurricane RX Biliary Balloon Dilatation Catheter
Medical device recall Z-0286-2021. Published in FDA’s Enforcement Report on Nov 4, 2020.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 4, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 15,062 devices distributed in US. 12,930 distributed OUS how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No. M00545890; M00545900; M00545910; M00545920; M00545930; M00545940; M00545950; M00545960 The device is a double lumen catheter with a balloon mounted at the distal tip. Dilatation balloon catheters are used to exert radial force to dilate narrow duct segments, as well as the Sphincter of Oddi.
15,062 devices distributed in US. 12,930 distributed OUS, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Hurricane RX Dilation Balloon 4 mm 2 cm UPN/REF # M00545890 GTIN # 08714729283805 Lot/Batch # 25509445, 25536219, 25612668, 25649812, 25704208 EXP Date Range 04/13/2022 - 06/13/2022 Hurricane RX Dilation Balloon 4 mm 4 cm UPN/REF #…
Every code shown here, 1,999 characters
Hurricane RX Dilation Balloon 4 mm 2 cm UPN/REF # M00545890 GTIN # 08714729283805 Lot/Batch # 25509445, 25536219, 25612668, 25649812, 25704208 EXP Date Range 04/13/2022 - 06/13/2022 Hurricane RX Dilation Balloon 4 mm 4 cm UPN/REF # M00545900 GTIN # 08714729283812 Lot/Batch # 25326198, 25344165, 25344168, 25366542, 25366543, 25379240, 25379241, 25392546, 25447687, 25447688, 25447689, 25447690, 25447691, 25447692, 25453103, 25453105, 25453108, 25466435, 25468596, 25468597, 25471588, 25479171, 25479176, 25479177, 25479178, 25479521, 25481983, 25481984, 25481985, 25481986, 25497466, 25497467, 25497468, 25506678, 25509440, 25509446, 25509447, 25509450, 25518274, 25518305, 25518314, 25533944, 25536416, 25536680, 25536860, 25543967, 25543969, 25571363, 25575934, 25575935, 25576717, 25576718, 25576719, 25576720, 25576721, 25576769, 25611564, 25612669, 25612670, 25612671, 25612673, 25612674, 25623377, 25623378, 25623379, 25623380, 25623381, 25623382, 25623383, 25623384, 25640115, 25649813, 25649816, 25678821, 25678826, 25678831, 25678836, 25680096, 25704209, 25704210, 25704211, 25704212, 25704213, 25704214, 25704215, 25704216, 25739146, 25739147, 25739149, 25739150, 25771761, 25771762, 25771765 EXP Date Range 02/07/2022 - 06/27/2022 Hurricane RX Dilation Balloon 6 mm 2 cm UPN/REF # M00545910 GTIN #08714729283829 Lot/Batch # 25456946, 25497472, 25571369, 25623385, 25678822, 25739151 EXP Date Range 03/22/2022 - 06/20/2022 Hurricane RX Dilation Balloon 6 mm 4 cm UPN/REF # M00545920 GTIN # 08714729283836 Lot/Batch # 25305803, 25326193, 25326194, 25326195, 25326199, 25334817, 25334818, 25366544, 25366545, 25366546, 25366547, 25392549, 25392551, 25392553, 25392554, 25392555, 25397943, 25397944, 25447697, 25447698, 25453106, 25453109, 25461680, 25466436, 25468598, 25472425, 25475235, 25475236, 25479172, 25479173, 25479179, 25481987, 25481988, 25481989, 25481990, 25481991, 25497469, 25497470, 25497473, 25497474, 25497475, 25509412, 25509413, 25509414, 25509451, 25509452, 25509453,…
FDA’s list runs to 4,750 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution - US Nationwide and International distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 16, 2020.
- FDA classified it on Oct 23, 2020.
- FDA’s Enforcement Report published it on Nov 4, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Boston Scientific Corporation, of Marlborough, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 4,750 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.