The Recall Desk

FDA (Devices) recall action 71849

Boston Scientific Corporation recalled 4 products on 2015-08-19

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2015-08-19
Critical
0
Units
36

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • ModerateFDA (Devices)··2015-08-19

    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.

    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…
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2015-08-19

    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.

    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…
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··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.

    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…
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2015-08-19

    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.

    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…
    Category
    Distribution
    3 states