Boston Scientific Recalls AngioJet Thrombectomy Sets Due to Incorrect Expiry Dates
Boston Scientific is recalling 9 AngioJet SOLENT Omni Thrombectomy Sets because they were labeled with an incorrect use-by date of December 2015 instead of November 2015.
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 Moderate because it involves a minor labeling error (incorrect expiry date) without reported injuries or illnesses, fitting the criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Boston Scientific Corporation is recalling 9 units of the AngioJet SOLENT Omni Thrombectomy Set (UPN 109681-004 & 109681-001, Catalog No 109681). These sterile medical devices are used with the AngioJet Ultra System to break apart and remove thrombus from the vascular system and A-V access conduits.
The recall was initiated because the products were distributed with an incorrect use-by (expiry) date. The units are labeled with a use-by date of December 2015, but the correct date is November 2015.
The affected units were distributed worldwide, including in the United States (Arizona, Missouri, and Ohio) and internationally to Germany and Spain. Healthcare facilities and distributors should stop using these specific units and contact Boston Scientific for instructions on return or replacement.
The recalled product
- Product
- AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 109681, Sterilized. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing…
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 9
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)
- 162185 162318
Distribution
Part of a larger recall action
This product is one of 4 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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