Boston Scientific JAGTOME RX device recalled for sterile barrier breach
Boston Scientific has recalled 2209 units of the JAGTOME RX medical device worldwide due to compromised sterility from a sterile barrier breach. The affected units were distributed across the US and more than 40 countries.
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 a risk-of-harm medical device where a sterile barrier breach has been confirmed but no injuries or illnesses have been reported. The defect meets the rubric criterion for High severity as a risk-of-harm product without reported injury.
Plain-English summary
Boston Scientific Corporation is recalling 2209 units of the JAGTOME RX 44-30-260-035 medical device due to a sterile barrier breach that compromises the device's sterility. The recall affects units distributed worldwide, including across the United States and over 40 additional countries.
The sterile barrier breach is a manufacturing defect that affects the integrity of the device's sterile packaging. Affected lot numbers include Batch 27522394, 27566792, 27589267, 27618168, 27726335, 27758466, 27795807, 27822419, 27458135, 27472063, 27553565, 27649356, 27706277, 27758465, 27773622, 27821544, 27865086, 27986549, 28017367, and 28289453 (GTIN 8714729776673).
Consumers and healthcare providers who have received this device should stop use immediately and contact Boston Scientific for instructions on return or replacement. No injuries or illnesses have been reported. The FDA classified this as a Class II device recall.
The recalled product
- Product
- JAGTOME RX 44-30-260-035 Material Number: M00573060
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device
- Hazard
- Affected units
- 2,209
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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