Boston Scientific Recalls Mislabeled AMS 800 Artificial Urinary Sphincter Cuffs
Boston Scientific is recalling AMS 800 Artificial Urinary Sphincter belt cuffs labeled as 4.5 cm but measuring 4.0 cm due to mislabeling.
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, which typically involves a temporary or medically reversible adverse health consequence. The hazard is mislabeling of a medical device dimension, which is a significant labeling error but does not explicitly state reported injuries or deaths in the provided text, fitting the Moderate criteria for labeling errors.
Plain-English summary
Boston Scientific Corporation is recalling the AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm, Part Number 72400161. The recall is due to a mislabeling issue where the occlusive cuff was labeled as 4.5 cm but was actually a length of 4.0 cm.
The affected units are identified by Lot Number 23973023. The distribution pattern is listed as MN, indicating distribution to Minnesota. The quantity recalled is 1 unit.
Consumers and healthcare providers should check their inventory for this specific part number and lot number. If the product is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed by Boston Scientific.
The recalled product
- Product
- AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 1
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 Number: 23973023
Distribution
Distributed in 1 state:
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