Boston Scientific JAGTOME REVOLUTION RX medical device sterile barrier breach recall
Boston Scientific is recalling 7,115 units of JAGTOME REVOLUTION RX devices worldwide due to sterile barrier breach that could allow 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: FDA Class II recall for device sterility defect. Although the hazard poses significant infection risk from contamination, no illnesses or injuries have been reported, placing this in the High category per the rubric for risk-of-harm products without yet-reported injury.
Plain-English summary
Boston Scientific Corporation is recalling 7,115 units of the JAGTOME REVOLUTION RX 39-20-260-025 medical device (Material Number M00584240). The recall is due to a sterile barrier breach that compromises the sterility of the device.
The affected devices were distributed worldwide, including throughout the United States and internationally to Australia, Austria, Belgium, Canada, China, France, Germany, Japan, and over 35 additional countries. The affected lot numbers are 27481920, 27524107, 27525279, 27530542, 27574053, 27598798, 27652479, 27722062, 27722511, 27742261, 27758891, 27795634, 27846706, 27897451, 27969768, 28027118, and 28070708.
A sterile barrier breach can allow the device to become contaminated, creating a risk of infection. Patients and healthcare providers using affected units should contact Boston Scientific Corporation for instructions regarding return or replacement of the device.
The recalled product
- Product
- JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device
- Affected units
- 7,115
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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