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.
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 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
- Hazard
- sterile-barrier-breach
- infection-risk
Distribution
Distributed nationwide across the United States.
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