Sterile Barrier Breach in JAGTOME RX Medical Devices Worldwide
Boston Scientific is recalling 4,487 JAGTOME RX medical devices worldwide due to sterility compromise from a sterile barrier breach. Users face contamination risk if devices are used.
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 of a sterile medical device with compromised sterility due to sterile barrier breach poses a risk of patient infection and contamination. No illnesses or injuries have been reported, qualifying this as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling the JAGTOME RX 39-20-260-025 medical device (Material Number: M00573080) in batches totaling 4,487 units. The devices have been distributed worldwide to the United States and more than 40 countries.
The recall was initiated because the sterility of the devices has been compromised due to a sterile barrier breach. Sterile medical devices must maintain their sterile condition to prevent contamination and infection when used in patients.
The affected lot numbers are: 27505913, 27563424, 27629942, 27731957, 27755861, 27839657, 27846391, 27986551, 27991931, and 28036372 (GTIN: 8714729776642).
Patients and healthcare providers who have received or may use these devices should contact Boston Scientific Corporation or their healthcare provider for instructions on return or replacement.
The recalled product
- Product
- JAGTOME RX 39-20-260-025 Material Number: M00573080
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device
- Affected units
- 4,487
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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