Agency classClass IIOur severity:High FDA (Devices)·Z-0323-2022·Announced 2021-12-08

Boston Scientific HURRICANE RX Dilation Balloon Pressure Loss Recalled

Boston Scientific is recalling HURRICANE RX Dilation Balloons across the US due to pinhole defects that cause pressure loss during endoscopic procedures. The defect may prolong procedures and affect patient safety.

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: This is a Class II medical device recall involving a functional defect (pinhole causing pressure loss) that can prolong endoscopic procedures and affect procedure outcomes. No illnesses, injuries, or deaths are reported in the source text. Per the rubric, a device defect without reported harm scores High (3) rather than Severe or Critical.

Plain-English summary

Boston Scientific Corporation is recalling HURRICANE RX Dilation Balloon (6MM 4CM) devices distributed nationwide. These balloons are used for endoscopic dilatation of strictures in the biliary tree and the Sphincter of Oddi.

The recall is due to pinhole defects in the balloon material that result in loss of pressure or failure to gain or maintain pressure during use. This malfunction can cause procedures to be prolonged, potentially affecting procedure outcomes and patient safety.

Affected batches distributed nationwide include lot numbers ranging from 25576770 through 27384715. The affected devices expire between May 10, 2022 and May 26, 2023 (GTIN: 08714729283836).

If you have affected units in inventory, discontinue use and contact Boston Scientific for return, replacement, or disposal instructions.

The recalled product

Product: HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545920
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Endoscopic Equipment
Hazard: pressure-loss
balloon-defect
device-failure
prolonged-procedure

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: 08714729283836 Batches: 25576770
25576881
25576882
25576883
25576884
25576885
25608762
25623386
25623387
25623388
25623389
25623390
25623391
25623392
25623393
25623394
25623395
25623396
25623397
25623398

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