Medical device sterile barrier breach compromises sterility in JAGTOME RX
Boston Scientific is recalling 98 JAGTOME RX medical devices due to a sterile barrier breach. The affected units 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 recall involving a sterile barrier breach on a medical device, which creates potential infection and contamination risk. No illnesses or injuries have been reported in the source material, making this a risk-of-harm product without yet-reported harm.
Plain-English summary
Boston Scientific Corporation is recalling 98 JAGTOME RX 39-30-450-025 medical devices (Material Number: M00573110, Lot Number: 27857328) due to a sterile barrier breach that compromises the sterility assurance of the devices.
A sterile barrier breach means the devices may not maintain their sterile condition as required for safe use. This poses a potential risk of infection or contamination if the affected devices are implanted or used.
The recalled devices were distributed worldwide, including throughout the United States and internationally to over 40 countries. Patients who have received these devices should contact their healthcare provider immediately to discuss potential risks and next steps.
Healthcare facilities should quarantine and account for affected devices and contact Boston Scientific Corporation for return or replacement instructions. The FDA has assigned recall number Z-0772-2022 to this recall.
The recalled product
- Product
- JAGTOME RX 39-30-450-025 Material Number: M00573110
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device
- Affected units
- 98
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: 27857328 GTIN: 8714729776529
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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