Medical Device Sterile Barrier Breach: JAGTOME RX Recall
Boston Scientific is recalling JAGTOME RX medical devices because the sterile barrier may be compromised, which could allow contamination. The recall affects 163 units 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 recall involving a compromised sterile barrier on a medical device, which presents a risk of harm if the device is used. No illnesses, hospitalizations, or injuries have been reported. Per the rubric, a risk-of-harm product where injury has not been reported scores 3 (High).
Plain-English summary
Boston Scientific Corporation is recalling JAGTOME RX medical devices (Material Number M00573070) due to a compromised sterile barrier. The recall involves 163 units with lot numbers 27737251, 27970819, 28289451, 27821545, and 28019275.
The sterile barrier protects the device from contamination before use. When the sterile barrier is compromised, the device may become contaminated, potentially causing infection if implanted or used clinically. No infections or adverse events have been reported to date.
The affected devices were distributed worldwide, including throughout the United States and internationally to countries including Australia, Austria, Belgium, Canada, China, France, Germany, Japan, and many others. Consumers who have received these devices should consult with their healthcare provider immediately to determine if they have an affected device and whether any action is needed.
The recalled product
- Product
- JAGTOME RX 44-30-450-035 Material Number: M00573070
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device
- Affected units
- 163
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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