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Recall Observatory FDA recall evidence

Device 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 thrombus from A-V access conduits.

Z-2380-2015

July 31, 2015

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 71849
Status
Terminated
Classification
Class II
Quantity
total of 9 units
Official record key
device-enforcement:Z-2380-2015

Official wording

Reason: AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015.

Code information: 163390

Distribution pattern: Worldwide Distribution - US including AZ, MO, OH and Internationally to GERMANY and SPAIN.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015.