Boston Scientific DREAMTOME Stent Devices Recalled for Sterility Compromise
Boston Scientific is recalling 472 DREAMTOME stent devices due to sterile barrier breach affecting product sterility. Devices were distributed worldwide including the US.
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 medical device with a sterile barrier breach that creates a risk of infection. Since no illnesses or injuries have been reported, the recall meets the rubric criterion for Score 3 (High): a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling 472 units of the DREAMTOME 49-30MM/260CM stent device (Material Number: M00584010) distributed worldwide. The recall is due to a sterile barrier breach that compromises the sterility of the device.
The sterility compromise creates a risk of infection or other serious complications if the affected devices are implanted. No illnesses or injuries have been reported in connection with this recall.
The affected devices were distributed throughout the US and to approximately 40 countries worldwide, including Australia, Austria, Belgium, Canada, China, France, Germany, Great Britain, Japan, Korea, and others. The specific lot numbers involved are 27566790, 27641143, and 27852432.
Healthcare providers and patients who may have received these devices should contact Boston Scientific for guidance on return or replacement.
The recalled product
- Product
- DREAMTOME 49-30MM/260CM Material Number: M00584010
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Stent
- Hazard
- sterile-barrier-breach
- infection-risk
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 (1)
- Lot Numbers: 27566790 27641143 27852432 GTIN: 8714729778233
Distribution
Distributed nationwide across the United States.
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