The Recall Desk

FDA (Devices) recall action 78587

Boston Scientific Corporation recalled 2 products on 2018-02-28

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2018-02-28
Critical
0
Units
45,832

Why these products were recalled

Stent possibly unable to be fully released from the delivery system.

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

1–2 of 2

  • HighFDA (Devices)··2018-02-28

    Boston Scientific Recalls Innova Self-Expanding Stent Systems Due to Release Defect

    Boston Scientific is recalling 22,916 Innova Self-Expanding Stent Systems because they may not fully release from the delivery system.

    Product
    Innova Self-Expanding Stent System, 180mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the
    Category
    Distribution
    47 states
  • HighFDA (Devices)··2018-02-28

    Boston Scientific Recalls Innova Self-Expanding Stent Systems Due to Release Defect

    Boston Scientific is recalling 22,916 units of the Innova Self-Expanding Stent System because the stent may not fully release from the delivery system.

    Product
    Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the n
    Category
    Distribution
    47 states