Agency classClass IIOur severity:High FDA (Devices)·Z-0321-2022·Announced 2021-12-08

Boston Scientific Hurricane RX Dilation Balloon Recalled for Pressure Loss

Boston Scientific is recalling Hurricane RX dilation balloons used in endoscopic biliary procedures due to pinhole defects causing pressure loss that may prolong treatment.

The agency’s classification

FDA (Devices): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with documented functional defect (pressure loss due to pinholes) affecting its critical function. Risk-of-harm device where no injuries have been reported, but the malfunction creates potential for procedural complications.

Plain-English summary

Boston Scientific Corporation is recalling the Hurricane RX Dilation Balloon 4MM 4CM, a medical device used in endoscopic procedures to dilate strictures of the biliary tree and Sphincter of Oddi.

The recall is due to pinhole defects that cause loss of pressure or prevent the balloons from gaining and maintaining pressure during procedures. This can result in prolonged procedures.

The affected balloons expire between May 10, 2022 and May 31, 2023 and were distributed nationwide in the United States. A detailed list of affected lot numbers is available in the recall notice.

Healthcare providers should verify their device inventory against the affected lot numbers. Contact Boston Scientific Corporation for further information about this recall.

The recalled product

Product: HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545900
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Endoscopic / Biliary
Hazard: pressure-loss
device-malfunction

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

GTIN: 08714729283812 Lot Numbers: 25576719
25576720
25576721
25576769
25611564
25612669
25612670
25612671
25612673
25612674
25623377
25623378
25623379
25623380
25623381
25623382
25623383
25623384
25640115
25649813

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

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Same hazard · pressure loss