The Recall Desk
HighFDA (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.

What this means for you

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

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 →

Related recalls

Same manufacturer · Boston Scientific Corporation

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Same hazard · pressure loss

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