Medical Device JAGTOME RX Recalled for Compromised Sterile Barrier
Boston Scientific is recalling 3,578 units of the JAGTOME RX medical device because the sterile barrier is compromised, which can allow contamination. 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: FDA Class II medical device with a sterile barrier breach that creates risk of product contamination and potential infection. No illnesses or injuries have been reported. This meets the criterion of a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling 3,578 units of the JAGTOME RX medical device (Material Number: M00573050) due to a compromise in the sterile barrier. The sterile barrier is essential for maintaining the device's sterility and preventing contamination, and a breach in this barrier means the device may not be safe for use.
The recall involves eight lot numbers: 27535120, 27643043, 27730949, 27836207, 27571950, 27591704, 27625065, and 27773387 (GTIN: 8714729776666). These units were distributed worldwide, including to the United States, Australia, Canada, France, Germany, Japan, and numerous other countries.
If you have received or are using one of the affected devices, do not use it. Contact Boston Scientific Corporation or the FDA for guidance on replacement or safe handling. The FDA and manufacturer continue to monitor this situation.
The recalled product
- Product
- JAGTOME RX 44-20-450-035 Material Number: M00573050
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device
- Affected units
- 3,578
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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