Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported November 4, 2020
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.
RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Boston Scientific Corporation recalled Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No. M00545890; M00545900; M… - a moderate-severity action.
Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No. M00545890; M00545900; M… was recalled by Boston Scientific Corporation in November 4, 2020. Reason: RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength.. Check the official notice for the remedy. Verify recall #Z-0286-2021 with the FDA Devices before acting.
The recall
Boston Scientific Corporation issued this moderate-severity FDA Devices recall-RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength..
- Moderate
- severity level
- 15K units
- affected scope
- Class II
- classification
- November 4, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0286-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0286-2021) was formally reported on November 4, 2020, with the manufacturer initiating the action on September 16, 2020. It is classified under Moderate severity (Class II), with a current status of Ongoing. Boston Scientific Corporation is listed as the recalling firm, operating out of Marlborough, MA. Federal records list the affected scope as 15,062 devices distributed in US. 12,930 distributed OUS.
The documented reason for this recall is: RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength. Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and International distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Where this recall sits in the database
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
15,062 devices distributed in US. 12,930 distributed OUS
Related Recalls
6
0 from same agency
Product description
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.
Reason for recall
RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0286-2021 |
| Date reported | November 4, 2020 |
| Date initiated | September 16, 2020 |
| Recalling firm | Boston Scientific Corporation |
| Firm location | Marlborough, MA |
| Affected scope | 15,062 devices distributed in US. 12,930 distributed OUS |
| Distribution | Worldwide distribution - US Nationwide and International distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0286-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was 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.. Recalled by Boston Scientific Corporation. Units affected: 15,062 devices distributed in US. 12,930 distributed OUS.
Why was this product recalled? ▼
RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 4, 2020. Severity: Moderate. Recall number: Z-0286-2021.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide and International distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0286-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported November 4, 2020.
- Source: FDA - Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA - National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.