The Recall Desk

FDA (Devices) recall action 84152

Boston Scientific Corporation recalled 4 products on 2019-12-04

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
2019-12-04
Critical
0
Units
56,580

Why these products were recalled

Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.

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

  • HighFDA (Devices)··2019-12-04

    Boston Scientific Recalls Rebel Monorail Coronary Stent Systems

    Boston Scientific is recalling 14,145 Rebel Monorail PtCr Coronary Stent Systems because they may be missing a hydrophilic coating step.

    Product
    Rebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, Rebel MR OUS 3.0mm x 24mm. The Rebel Monorail (MR) Stent System is a balloon expandable Platinum Chromium (PtCr) Alloy stent pre-mounted on a Monorail Catheter.
    Category
    Distribution
    2 states
  • ModerateFDA (Devices)··2019-12-04

    Boston Scientific Recalls NC Emerge Monorail PTCA Catheters for Coating Defect

    Boston Scientific is recalling NC Emerge Monorail PTCA Dilatation Catheters because they may be missing a hydrophilic coating step during manufacturing.

    Product
    NC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493926708350, NC EMERGE MR US 3.50MM X 8MM; 2. REF/Catalog No. H7493927608350, NC EMERGE MR OUS 3.50MM X 8MM; 3. REF/Catalog No.…
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2019-12-04

    Boston Scientific Recalls Emerge Monorail PTCA Catheters Due to Coating Defect

    Boston Scientific is recalling Emerge Monorail PTCA Dilatation Catheters because they may lack a required hydrophilic coating. The recall covers 14,145 devices distributed nationwide and in Canada.

    Product
    Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493919308200 EMERGE MR, OUS 2.00mm X 8mm; 2. REF/Catalog No. H7493918912200, EMERGE MR US 2.00MM X 12MM; 3. REF/Catalog No.…
    Category
    Distribution
    2 states
  • ModerateFDA (Devices)··2019-12-04

    Boston Scientific Recalls Guidezilla II Catheters Due to Missing Coating

    Boston Scientific is recalling Guidezilla II Guide Extension Catheters because they may lack a hydrophilic coating, potentially affecting device performance.

    Product
    Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493933515060, 6F; 2. REF/Catalog No H7493933515070, 7F.
    Category
    Distribution
    2 states