Medical Device Sterility Compromise Recall by Boston Scientific
Boston Scientific has recalled 3,578 units of the JAGTOME RX medical device due to sterility compromise from a barrier breach. 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: Class II recall involving sterile barrier compromise on a medical device. No illnesses or injuries reported. Classified as High (3) per rubric criterion: risk-of-harm product without reported injury.
Plain-English summary
Boston Scientific Corporation has recalled 3,578 units of the JAGTOME RX 44-20-260-035 medical device (Material Number M00573040) due to a sterility compromise.
The recall was issued because the sterile barrier of the device has been compromised. This creates a potential risk to patients who may receive the affected device, as the sterile barrier is essential to maintaining device safety.
The recalled product was distributed worldwide, including to customers in the United States and numerous international locations. The affected units are identified by specific lot numbers: 27465198, 27515974, 27595732, 27625064, 27720618, 27737252, 27765472, 27833280, 27883444, 28002224, 28296772, 27491776, 27595731, 27618170, 27718421, 27758432, 27764571, 27830207, 27858381, 28002225, and 28289452. The GTIN is 8714729776659.
Healthcare providers and patients with affected units should contact Boston Scientific Corporation immediately for instructions on device return or replacement. Do not use any units from the affected lot numbers.
The recalled product
- Product
- JAGTOME RX 44-20-260-035 Material Number: M00573040
- 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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