Boston Scientific Recalls Imager II Angiographic Catheters Due to Packaging Mislabeling
Boston Scientific is recalling Imager II Angiographic Catheters because some packages are mislabeled as Contra 2 curve catheters when they contain Contra curve catheters.
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 a minor labeling error where the product is mislabeled as a different curve type, which fits the criteria for moderate severity.
Plain-English summary
Boston Scientific Corporation is recalling one lot of Imager II Angiographic Catheters due to packaging mislabeling. The affected product may be labeled as Imager II Contra 2 curve catheters, but the package actually contains Contra curve catheters.
The recall involves 26 boxes of 5 units (130 singles) from Lot 00116127, with an expiration date of September 30, 2018. The product was distributed in Arizona, Florida, Missouri, New Jersey, New York, Ohio, Pennsylvania, and Texas.
Healthcare facilities and consumers should check their inventory for this specific lot number and product description. If the product is found, it should be removed from use and returned to the distributor or Boston Scientific Corporation for credit.
The recalled product
- Product
- Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN)
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Catheter
- Hazard
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 (3)
- Lot: 00116127
- Expiration Date: September 30
- 2018
Distribution
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