Boston Scientific Recalls MAMBA Flex 135 Microcatheters for Labeling Errors
Boston Scientific is removing specific batches of MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.
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 involves incorrect labeling and packaging. The source text does not report any illnesses or injuries, fitting the criteria for a moderate severity recall involving labeling errors.
Plain-English summary
Boston Scientific Corporation has initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters. The action is being taken because of incorrect labeling and packaging associated with these specific devices.
The affected devices are packaged with a protective sleeve over the catheter, sealed in a Tyvek pouch, and placed in a carton with an instruction for use (IFU). The recall involves 52 devices from batches 26578463 and 26578470, which have an expiration date of January 4, 2023.
These devices were distributed nationwide to various U.S. states and internationally to several countries. The source text does not specify any reported illnesses or injuries associated with this recall.
The recalled product
- Product
- MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton.
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Microcatheter
- Hazard
- Affected units
- 52
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 (4)
- UPN: H7493928713540 US (Green)
- Batches: 26578463 and 26578470
- GTIN: 8714729940289
- and Expiration Date: 4-Jan-23
Distribution
Part of a larger recall action
This product is one of 2 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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