Terumo Recalls MISAGO RX Self Expanding Peripheral Stent
Terumo Medical Corp is recalling 7,965 MISAGO RX Self Expanding Peripheral Stents nationwide because they do not conform to product specifications regarding diameter and shape.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity recall involving product specification non-conformance.
Plain-English summary
Terumo Medical Corp is recalling 7,965 units of the MISAGO RX Self Expanding Peripheral Stent. The recall is being conducted nationwide.
The recall was initiated after routine testing revealed that the stents did not conform to product specifications. Specifically, the devices failed to meet standards related to the stent diameter at the proximal and distal ends and/or the overall shape of the stent.
The source text does not specify the exact actions consumers or healthcare providers should take, nor does it report any specific injuries or illnesses associated with the non-conforming devices.
The recalled product
- Product
- MISAGO RX Self Expanding Peripheral Stem
- Manufacturer
- Terumo Medical Corp
- Hazard
- Affected units
- 7,965
Distribution
Distributed nationwide across the United States.
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