Hurricane RX Dilation Balloon Recalled for Pressure Loss Defect
Boston Scientific is recalling the Hurricane RX Dilation Balloon due to a pinhole defect causing pressure loss during endoscopic procedures. The defect may result in prolonged procedures and inability to effectively treat biliary strictures.
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: FDA Class II medical device recall for a functional defect preventing the balloon from maintaining pressure during critical biliary procedures. While no patient injuries are explicitly reported in the source, the inability of the device to function as intended represents a risk-of-harm situation.
Plain-English summary
Boston Scientific Corporation is recalling the Hurricane RX Dilation Balloon 6MM 2CM nationwide. The device is designed for endoscopic dilation of strictures in the biliary tree and the Sphincter of Oddi.
The recall was initiated because a pinhole defect in the balloon causes it to lose pressure or fail to gain or maintain adequate pressure during use. This results in prolonged procedures and may prevent completion of the intended dilation.
Affected units have GTIN 8714729283829 and include 24 batch numbers (25623385 through 27400203), with expiration dates ranging from May 23, 2022, to May 28, 2023. The device was distributed nationwide in the United States.
Healthcare providers and patients should contact Boston Scientific if they experience pressure loss or inability to maintain pressure with affected balloons. Device replacement or return instructions are available through Boston Scientific customer service.
The recalled product
- Product
- HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:M00545910
- Manufacturer
- Boston Scientific Corporation
- Hazard
- device-malfunction
- pressure-loss
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: 8714729283829 Batches: 25623385
- 25678822
- 25739151
- 25771772
- 25975774
- 26010392
- 26051928
- 26087733
- 26123186
- 26175469
- 26406521
- 26429810
- 26456904
- 26579839
- 26581406
- 26601326
- 26660957
- 26793786
- 26896864
- 27026985
Distribution
Distributed nationwide across the United States.
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