The Recall Desk

FDA (Devices) recall action 78607

Stryker Neurovascular recalled 3 products on 2017-12-27

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2017-12-27
Critical
0
Units
5

Why these products were recalled

Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack.

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.

1–3 of 3

  • ModerateFDA (Devices)··2017-12-27

    Stryker Neurovascular Recalls Stroke Intervention Kits Due to Label Mismatch

    Stryker Neurovascular is recalling 2 units of Stroke Fast Packs and Trevo Procedure Packs because the carton sleeve labels did not match the physical contents inside.

    Product
    Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm), MICROCATHETER,150 cm, 6 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm, UPN M0033PK62523002 Stroke intervention kit
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2017-12-27

    Stryker Neurovascular Recalls Stroke Intervention Kits Due to Label Mismatch

    Stryker Neurovascular is recalling specific Stroke Fast Packs and Trevo Procedure Packs because the carton sleeve labels did not match the physical contents inside the packs.

    Product
    Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 mm, ; Trevo(TM) Pro 18, TREVO PRO 18 MICROCATHETER, 0.021 in ID, 150 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm; UPN M0033PK42022002 Stroke intervention kit
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2017-12-27

    Stryker Recalls Stroke Intervention Kits Due to Label Mismatch

    Stryker Neurovascular is recalling specific stroke intervention kits because the carton sleeve labels did not match the physical contents inside the packs.

    Product
    Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, .Excelsior(TM) XT-27(TM) 1 TIP STRAIGHT, 150 cm, 6 cm, Microcatheter; UPN 93068 Stroke intervention kit
    Category
    Distribution
    0 states