Boston Scientific DREAMTOME medical devices recalled for sterile barrier breach
Boston Scientific is recalling 982 units of DREAMTOME medical devices due to sterile barrier breach that compromises device sterility. Affected units were distributed worldwide.
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 recall with a sterile barrier breach that compromises device sterility. This represents a risk-of-harm product where injury has not yet been reported. No illnesses or injuries are mentioned in the source, limiting the severity per rubric criteria.
Plain-English summary
Boston Scientific Corporation is recalling 982 units of the DREAMTOME 49-20MM/260CM medical device (Material Number: M00584000) because the sterile barrier has been breached, compromising the sterility of the device.
A sterile barrier breach on a medical device compromises device integrity and creates the potential for contamination. The recalled devices have this defect.
The affected devices were distributed worldwide, including in the United States and more than 40 other countries including Canada, Australia, Japan, and numerous European nations. The affected lot numbers are: 27566791, 27604633, 27690970, 27802364, 27951185, and 28028721.
Healthcare providers and medical facilities who have received these devices should verify their inventory against the affected lot numbers and cease use of any devices matching the recalled lots. Contact Boston Scientific Corporation for further information and instructions on device handling.
The recalled product
- Product
- DREAMTOME 49-20MM/260CM Material Number: M00584000
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device
- Hazard
- Affected units
- 982
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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