Boston Scientific DREAMTOME Medical Device Recalled for Sterile Barrier Breach
Boston Scientific is recalling 142 units of DREAMTOME 44-30MM/450CM medical devices distributed worldwide due to a sterile barrier breach that compromises device sterility. Affected lot numbers are 27625066 and 27805561.
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: This is an FDA Class II recall of a medical device with a compromised sterile barrier, presenting potential infection risk. No illnesses or injuries have been reported, and per the rubric, risk-of-harm products without reported injury are classified as High.
Plain-English summary
Boston Scientific Corporation is recalling 142 units of the DREAMTOME 44-30MM/450CM medical device (material number M00584070). The recall involves devices from lot numbers 27625066 and 27805561 (GTIN 8714729778295).
The recall was initiated because a sterile barrier breach compromises the sterility of the device. This defect creates a potential risk of infection if the affected device is used.
The recalled devices were distributed worldwide, including to the United States and to healthcare facilities in Australia, Austria, Belgium, Canada, China, France, Germany, Japan, and numerous additional countries.
No illnesses or injuries related to this recall have been reported. This was classified as a Class II recall.
The recalled product
- Product
- DREAMTOME 44-30MM/450CM Material Number: M00584070
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device
- Affected units
- 142
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: 27625066 27805561 GTIN: 8714729778295
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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