Boston Scientific JAGTOME RX Device Recalled for Sterile Barrier Breach
Boston Scientific is recalling 14 JAGTOME RX medical devices worldwide due to a sterile barrier breach that compromises the device's sterility.
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 for a compromised sterile barrier on a medical device, which constitutes a risk-of-harm product. No illnesses or injuries have been reported, making this a precautionary recall based on the theoretical hazard of device sterility compromise.
Plain-English summary
Boston Scientific Corporation is recalling 14 units of the JAGTOME RX 49-30-450-035 medical device (Material Number M00573030, Lot Number 27951184). The recall is due to a sterile barrier breach that compromises the device's sterility.
The sterile barrier of a medical device is designed to maintain sterile conditions. A breach of this barrier means the device may not have maintained its sterility as intended.
The affected devices have been distributed worldwide, including throughout the United States and to numerous countries including Australia, Austria, Belgium, Canada, China, Denmark, France, Germany, Great Britain, Ireland, Italy, Japan, Korea, Netherlands, New Zealand, Poland, Spain, Sweden, Switzerland, and the United Arab Emirates, among others.
The recalled product
- Product
- JAGTOME RX 49-30-450-035 Material Number: M00573030
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device
- Affected units
- 14
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: 27951184 GTIN: 8714729776741
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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