The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0326-2022·Announced 2021-12-08

Boston Scientific HURRICANE RX Dilation Balloon Recalled for Pressure Loss

Boston Scientific is recalling HURRICANE RX Dilation Balloons due to a pinhole defect that causes pressure loss during endoscopic procedures. The device may fail to maintain necessary pressure, potentially prolonging procedures.

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 a pressure-loss defect that creates risk of harm during invasive endoscopic procedures, but no illnesses or injuries have been reported in the source material.

Plain-English summary

Boston Scientific Corporation is recalling the HURRICANE RX Dilation Balloon (10mm, 2cm), a medical device used for endoscopic dilation of strictures in the biliary tree and the Sphincter of Oddi. The devices are affected by a pinhole defect that causes loss of pressure or prevents the balloon from gaining or maintaining pressure during use.

The pressure loss caused by the defect results in prolonged procedures, as the balloon cannot maintain the necessary pressure for effective dilation. The recall encompasses 16 batch numbers with expiration dates ranging from May 9, 2022 to May 27, 2023, and affects devices distributed nationwide in the United States.

This is an FDA Class II medical device recall.

The recalled product

Product
HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545950
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Endoscopic Dilation
Hazard

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 (16)

  • Batches: 25571372
  • 25673064
  • 25836146
  • 26010398
  • 26058426
  • 26123197
  • 26175501
  • 26216321
  • 26473779
  • 26759413
  • 26784680
  • 26848732
  • 26946145
  • 27121592
  • 27340635
  • 27393787 GTIN: 08714729283867 Exp. 05/09/2022 to 05/27/2023

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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