Boston Scientific Recalls AngioJet Thrombectomy Sets Due to Incorrect Expiry Date
Boston Scientific is recalling 9 AngioJet SOLENT Dista 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 FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a labeling error regarding the expiry date, which fits the criteria for a moderate severity recall involving minor labeling errors or low-risk contamination.
Plain-English summary
Boston Scientific Corporation is recalling 9 units of the AngioJet SOLENT Dista Thrombectomy Set (UPN 111303-001, Catalog No. 111303). These 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 units were sterilized using ethylene oxide.
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. This labeling error could lead to the use of the device beyond its intended shelf life.
The affected units were distributed worldwide, including in the United States (Arizona, Missouri, and Ohio) and internationally to Germany and Spain. Healthcare providers and facilities that have received these specific units should stop using them and contact Boston Scientific for instructions on return or replacement.
The recalled product
- Product
- AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and…
- 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)
- 161905
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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