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.
What this means for you
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
- sterile-barrier-breach
Distribution
Distributed nationwide across the United States.
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