Hurricane RX Dilation Balloon Recalled Due to Pinhole Defect Causing Pressure Loss
Boston Scientific is recalling certain lots of the Hurricane RX Dilation Balloon due to a pinhole defect that causes loss of pressure or prevents the balloon from gaining or maintaining pressure during use, potentially prolonging medical procedures.
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 with a manufacturing defect (pinhole in balloon) causing pressure loss that impairs the device's intended function. No injuries or illnesses are reported in the source text; the defect represents a risk-of-harm to patients undergoing endoscopic procedures, meeting the criterion for High severity.
Plain-English summary
Boston Scientific Corporation has recalled certain lots of the Hurricane RX Dilation Balloon 8mm, 4cm, a medical device used for endoscopic dilatation of strictures in the biliary tree and Sphincter of Oddi.
The recall was initiated due to a manufacturing defect. Affected units contain a pinhole in the balloon that results in loss of pressure or prevents the balloon from gaining or maintaining pressure during use. This can prolong the endoscopic procedure and impair the device's ability to perform its intended function.
The affected product was distributed nationwide in the United States. The recall affects multiple lot numbers, with expiration dates ranging from May 2022 to May 2023.
Patients and healthcare providers should not use affected units. Contact Boston Scientific or consult your healthcare provider for guidance regarding affected devices. If complications have occurred, notify your healthcare provider immediately.
The recalled product
- Product
- HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545940
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device
- Hazard
- pressure-loss
- device-failure
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)
- Batches: 25608760
- 25612672
- 25649815
- 25649818
- 25649822
- 25649823
- 25649827
- 25649828
- 25649832
- 25649833
- 25678824
- 25678828
- 25678829
- 25678833
- 25678834
- 25678838
- 25680098
- 25680099
- 25704224
- 25704225
Distribution
Distributed nationwide across the United States.
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