The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0320-2022·Announced 2021-12-08

Boston Scientific Hurricane RX Dilation Balloons Recalled for Pressure Loss Defect

Boston Scientific is recalling specific lots of Hurricane RX Dilation Balloons due to a pinhole defect that causes pressure loss, resulting in prolonged endoscopic procedures. Affected devices are used for dilating strictures in the bile duct.

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 an FDA Class II recall of a medical device used in critical endoscopic procedures. The pinhole defect causes pressure loss during use, resulting in prolonged procedures that increase patient risk. Although no illnesses or injuries have been reported, the functional defect in a device used for critical bile duct procedures constitutes a significant risk of harm.

Plain-English summary

Boston Scientific Corporation is recalling specific lots of the Hurricane RX Dilation Balloon 4MM 2CM, a medical device used during endoscopic procedures to dilate strictures in the bile duct. The devices are distributed nationwide throughout the United States.

The balloons are being recalled due to a pinhole defect that causes pressure loss or failure to gain and maintain adequate pressure during use. This defect prolongs the endoscopic procedure, potentially increasing patient time under sedation and associated risks.

Healthcare providers and patients should immediately stop using affected devices from the identified lot numbers and contact Boston Scientific or the FDA. No injuries or illnesses have been reported at this time, but the defect poses a risk during clinical use.

The recalled product

Product
HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Endoscopic Equipment
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)

  • GTIN: 08714729283805 Lot Numbers: 25612668
  • 25649812
  • 25704208
  • 25771760
  • 25878552
  • 26000695
  • 26010387
  • 26058284
  • 26087172
  • 26087173
  • 26123181
  • 26324742
  • 26366746
  • 26406513
  • 26429808
  • 26499853
  • 26527374
  • 26573853
  • 26638827
  • 26651718

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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