Boston Scientific Recalls AngioJet Spiroflex Thrombectomy Sets Due to Incorrect Expiry Date
Boston Scientific is recalling nine AngioJet Spiroflex 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: This is a Class II recall involving a minor labeling error (incorrect expiry date) with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Boston Scientific Corporation is recalling nine units of the AngioJet Spiroflex Thrombectomy Set: Peripheral (UPN 106553-004, Catalog No. 106553). 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 correct use-by date is November 2015, but the affected units are labeled with a use-by date of December 2015.
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 received these specific units should stop using them and contact Boston Scientific for further instructions.
The recalled product
- Product
- AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.106553, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking…
- 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)
- 163580
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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