The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0327-2022·Announced 2021-12-08

FDA Recalls Hurricane RX Dilation Balloons for Pressure Failure Risk

Boston Scientific is recalling Hurricane RX Dilation Balloons nationwide due to pinhole defects that cause pressure loss or failure to maintain pressure during endoscopic 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 device with a mechanical failure mode (pinhole, pressure loss) used in invasive procedures. Meets the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Boston Scientific Corporation is recalling certain Hurricane RX Dilation Balloons (10mm diameter, 4cm length) with UPN M00545960. These medical devices are intended for endoscopic dilation of strictures in the biliary tree and sphincter of Oddi.

The recall was issued due to defects in certain balloons that cause pinhole leaks resulting in pressure loss or failure to gain or maintain pressure during use. When pressure cannot be achieved or maintained, the balloon cannot perform its intended dilation function, potentially resulting in prolonged or failed procedures.

The recall affects 176 batches of the device distributed nationwide across the United States. Affected batches range from 25608761 through 27384710, with expiration dates from May 18, 2022 to June 3, 2023.

The recalled product

Product
HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545960
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 (20)

  • Batches: 25608761
  • 25640116
  • 25640117
  • 25644834
  • 25649819
  • 25649824
  • 25649829
  • 25649834
  • 25678825
  • 25678830
  • 25678835
  • 25678839
  • 25678880
  • 25680560
  • 25704230
  • 25704231
  • 25704232
  • 25739169
  • 25739170
  • 25806714

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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