The Recall Desk
ModerateFDA (Devices)·Z-2380-2015·Announced 2015-08-19

Boston Scientific Recalls AngioJet AVX Thrombectomy Sets Due to Incorrect Expiry Date

Boston Scientific is recalling nine AngioJet AVX Thrombectomy Sets because they were labeled with an incorrect use-by date of December 2015 instead of November 2015.

What this means for you

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 the hazard is a minor labeling error regarding the expiry date, which fits the criteria for a moderate severity score.

Plain-English summary

Boston Scientific Corporation is recalling nine units of the AngioJet AVX Thrombectomy Set (UPN 105039-001, Catalog No. 105039). 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 products are sterilized using ethylene oxide and are intended for breaking apart and removing thrombus from the vascular system, specifically for use with the AngioJet Ultra System in A-V access conduits. The recall covers a total of 9 units.

Distribution of the affected units was worldwide, including the United States (specifically Arizona, Missouri, and Ohio) and internationally to Germany and Spain. The source text does not specify actions for consumers or healthcare providers beyond the recall notice.

The recalled product

Product
AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing th
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)

  • 163390

Distribution

Distributed in 3 states:

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.

See all 4 products in this recall →