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
- Hazard
- pressure-loss
- balloon-defect
- device-failure
- prolonged-procedure
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.
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