Boston Scientific Sphincterotome Recalled for Sterile Barrier Breach
Boston Scientific Corporation is recalling 1,811 units of Dreamtome Cannulating Sphincterotomes worldwide because the sterile barrier is compromised, creating a potential contamination risk.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 sterile barrier breach with no reported illnesses or injuries, meeting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Boston Scientific Corporation is recalling the Dreamtome Cannulating Sphincterotome (model DREAMTOME 44-20MM/450CM, Material Number M00584060). The device's sterile barrier has been compromised, which means the protective barrier that maintains device sterility has failed or been breached.
This recall affects 1,811 units distributed worldwide. Distribution includes the United States and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, and the United Arab Emirates. The affected lot numbers are 27463326, 27468730, 27553568, 27590928, 27629941, 27684747, 27764231, 27794744, 27837500, 27931763, 27986550, and 28058938 (GTIN 8714729778288).
A compromised sterile barrier on this endoscopic device creates a potential risk of microbial contamination during use. No illnesses have been reported to date.
Healthcare facilities and endoscopy centers that have received affected units should take appropriate steps to manage their inventory. Contact Boston Scientific Corporation for guidance on replacement, return, or further instructions regarding affected devices.
The recalled product
- Product
- Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 1,811
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 31 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.
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