Boston Scientific Medical Device Recalled Due to Sterile Barrier Breach
Boston Scientific is recalling 3,330 units of JAGTOME REVOLUTION RX devices due to a sterile barrier breach that compromises device sterility. The devices 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: This is an FDA Class II medical device recall for a sterile barrier breach that compromises device sterility. While the source does not report any illnesses or injuries, the breach represents a potential risk of harm. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Boston Scientific Corporation is recalling the JAGTOME REVOLUTION RX 39-30-260-025 (Material Number: M00584260), a medical device. A total of 3,330 units are included in this recall.
The recall is due to a sterile barrier breach that compromises the sterility of the device. A sterile barrier is designed to maintain the device in a sterile state, and any breach to this barrier can compromise that sterility.
The affected devices were distributed worldwide, including in the United States and internationally to 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, Russian Federation, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, and United Arab Emirates. The affected lot numbers are: 27482863, 27532553, 27602969, 27652583, 27723139, 27758892, 27796835, 27846707, 27899139, 27966498, and 28021411.
The recalled product
- Product
- JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device
- Affected units
- 3,330
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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