Boston Scientific recalls 68 medical devices with sterility breach
Boston Scientific is recalling 68 JAGTOME REVOLUTION RX medical devices due to sterile barrier breach. The devices were distributed worldwide including throughout the US.
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: FDA Class II recall with compromised sterile barrier creating contamination risk. No illnesses or injuries reported in source. Meets rubric criteria for High severity: risk-of-harm product where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling 68 units of the JAGTOME REVOLUTION RX 39-20-450-025 medical device (Material Number: M00584250, Lot Number: 27482864) due to a sterile barrier breach that compromises device sterility.
A compromised sterile barrier can allow contamination of the medical device, posing a potential risk to users.
The affected devices were distributed worldwide, including throughout 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.
Patients or healthcare providers who have or may have received these devices should contact Boston Scientific Corporation.
The recalled product
- Product
- JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device
- Affected units
- 68
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: 27482864 GTIN: 8714729953241
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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