Agency classClass IIOur severity:High FDA (Devices)·Z-0322-2022·Announced 2021-12-08

Hurricane RX Dilation Balloon Recalled for Pressure Loss Defect

Boston Scientific is recalling the Hurricane RX Dilation Balloon due to a pinhole defect causing pressure loss during endoscopic procedures. The defect may result in prolonged procedures and inability to effectively treat biliary strictures.

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 recall for a functional defect preventing the balloon from maintaining pressure during critical biliary procedures. While no patient injuries are explicitly reported in the source, the inability of the device to function as intended represents a risk-of-harm situation.

Plain-English summary

Boston Scientific Corporation is recalling the Hurricane RX Dilation Balloon 6MM 2CM nationwide. The device is designed for endoscopic dilation of strictures in the biliary tree and the Sphincter of Oddi.

The recall was initiated because a pinhole defect in the balloon causes it to lose pressure or fail to gain or maintain adequate pressure during use. This results in prolonged procedures and may prevent completion of the intended dilation.

Affected units have GTIN 8714729283829 and include 24 batch numbers (25623385 through 27400203), with expiration dates ranging from May 23, 2022, to May 28, 2023. The device was distributed nationwide in the United States.

Healthcare providers and patients should contact Boston Scientific if they experience pressure loss or inability to maintain pressure with affected balloons. Device replacement or return instructions are available through Boston Scientific customer service.

The recalled product

Product: HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:M00545910
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Endoscopic Dilation Equipment
Hazard: device-malfunction
pressure-loss

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: 8714729283829 Batches: 25623385
25678822
25739151
25771772
25975774
26010392
26051928
26087733
26123186
26175469
26406521
26429810
26456904
26579839
26581406
26601326
26660957
26793786
26896864
27026985

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 →

Same manufacturer · Boston Scientific Corporation

See all →

Severe
Boston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
Moderate
Boston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
High
Boston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
High
Boston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
High
Boston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09

Same hazard · device malfunction