The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0324-2022·Announced 2021-12-08

Boston Scientific Hurricane RX Dilation Balloon Recalled for Pressure Loss Defect

Boston Scientific is recalling the Hurricane RX Dilation Balloon nationwide due to a pinhole defect causing loss of pressure or failure to maintain pressure during endoscopic procedures used to 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: This is an FDA Class II medical device with a documented functional defect that prevents proper operation during endoscopic procedures. Although no injuries or hospitalizations have been reported, the defect poses a potential risk in procedures where balloon function is critical. This fits the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Boston Scientific Corporation is recalling the Hurricane RX Dilation Balloon 8MM 2CM nationwide due to a manufacturing defect involving a pinhole in the balloon. The defect can result in loss of pressure or failure to gain or maintain adequate pressure during endoscopic procedures.

The affected device is used to dilate strictures (narrowing) of the biliary tree and the Sphincter of Oddi during endoscopic procedures. Affected batches include: 25644951, 25649190, 25650286, 25651334, 25654287, 25947916, 25947918, 26010397, 26058298, 26406532, 26435581, 26449368, 26533973, 26555544, 26868194, 27074110, 27269956, 27384708. Affected units have expiration dates from May 27, 2022 to May 26, 2023.

When the balloon fails to maintain pressure, procedures may be prolonged. Healthcare facilities using the affected product should review their inventory against the batch numbers listed and discontinue use of affected units. Facilities should contact Boston Scientific for information about device replacement or return.

The recalled product

Product
HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545930
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 (18)

  • Batches: 25644951
  • 25649190
  • 25650286
  • 25651334
  • 25654287
  • 25947916
  • 25947918
  • 26010397
  • 26058298
  • 26406532
  • 26435581
  • 26449368
  • 26533973
  • 26555544
  • 26868194
  • 27074110
  • 27269956
  • 27384708. GTIN: 08714729283843 Exp. 05/27/2022 to 05/26/2023

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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