Boston Scientific DREAMTOME device recalled due to sterile barrier breach
Boston Scientific is recalling 12,067 DREAMTOME devices worldwide due to compromised sterility from a sterile barrier breach. The affected units may not be properly protected from contamination.
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 device recall involving compromised sterility from a sterile barrier breach. While no illnesses or injuries have been reported, the hazard presents a risk of harm through potential infection, applying the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling 12,067 units of the DREAMTOME 44-30MM/260CM medical device (Material Number: M00584050) due to a sterile barrier breach that compromises the device's sterility.
The sterile barrier on these devices has been breached, which means they may not provide the intended sterile protection. This could affect device safety and effectiveness.
The recall affects devices distributed worldwide, including the United States and approximately 40 other countries. The affected lot numbers are: 27453804, 27457431, 27549729, 27556712, 27575367, 27579180, 27605386, 27605881, 27660096, 27667092, 27672343, 27708191, 27709633, 27787771, 27789167, 27899695, 27924755, 27971482, 27976277, 27979230, 28047306, 28054381.
Healthcare providers and patients who have received devices from the affected lot numbers should contact Boston Scientific immediately. Do not use affected devices and consult with a healthcare provider about replacement options.
The recalled product
- Product
- DREAMTOME 44-30MM/260CM Material Number: M00584050
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device
- Affected units
- 12,067
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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