Boston Scientific Sphincterotome Device Recalled Due to Sterile Barrier Breach
Boston Scientific is recalling 21,309 units of the Dreamtome RX Cannulating Sphincterotome due to a sterile barrier breach that compromises device sterility, creating a potential infection risk to patients.
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 an FDA Class II recall for a surgical device with a compromised sterile barrier that poses a risk of infection. The source text does not report any illnesses, injuries, or hospitalizations, making this a risk-of-harm product without reported actual harm, placing it in the High category per the rubric.
Plain-English summary
Boston Scientific Corporation is recalling 21,309 units of the Dreamtome RX Cannulating Sphincterotome (Model 44-20MM/260CM, Material Number M00584040) due to a sterile barrier breach that compromises the device's sterility.
The sphincterotome is an endoscopic surgical instrument used in medical procedures. A compromised sterile barrier means the device may not maintain the sterile conditions required for safe use and could pose a risk of infection or contamination to patients.
The affected units were distributed worldwide to the United States and approximately 40 other countries, including Australia, Austria, Belgium, Canada, China, France, Germany, Japan, and others. Boston Scientific has identified 40 specific batch numbers as affected by this issue.
Healthcare facilities and clinicians with affected batch numbers should contact Boston Scientific Corporation and consult the FDA for handling instructions. Patients who have undergone procedures with these devices should speak with their healthcare provider if they have concerns about potential exposure.
The recalled product
- Product
- Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040
- Manufacturer
- Boston Scientific Corporation
- Hazard
- sterile-barrier-breach
Distribution
Distributed nationwide across the United States.
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