Boston Scientific Recalls MAMBA Microcatheters for Labeling Errors
Boston Scientific is recalling 63 MAMBA Microcatheters due to incorrect labeling and packaging. The devices were distributed nationwide and internationally.
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 minor labeling and packaging errors without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Boston Scientific Corporation is recalling 63 units of MAMBA 135 and MAMBA Flex 135 Microcatheters. The recall was initiated because of incorrect labeling and packaging on the devices.
The affected devices were distributed nationwide to 27 US states and territories, as well as internationally to Belgium, France, Great Britain, Israel, Italy, Lithuania, Netherlands, Poland, Puerto Rico, and Switzerland. The specific batches involved are identified by batch numbers 26578155 and 26578465, with expiration dates of January 4, 2023.
Healthcare providers and facilities should check their inventory for these specific batch numbers and stop using the affected devices. Consumers should contact their healthcare provider if they have received or used these devices.
The recalled product
- Product
- MAMBA 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
- Affected units
- 63
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 (6)
- MAMBA 135 CM US microcatheter: UPN: H7493928713500
- Batch: 26578155
- GTIN: 8714729940241
- Batch: 26578465
- GTIN: 8714729940265
- 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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