The Recall Desk

FDA (Devices) recall action 65919

Boston Scientific Corporation recalled 2 products on 2013-09-11

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
2013-09-11
Critical
0
Units
1,671

Why these products were recalled

Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Devices and Flextome Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilation Devices. Boston Scientific has determined that users may experience significant difficulty or inability to remove the protector cap from the devic

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

  • ModerateFDA (Devices)··2013-09-11

    Boston Scientific Recalls Small Peripheral Cutting Balloon Catheters

    Boston Scientific is recalling 4.0mm x 15mm Small Peripheral Cutting Balloon catheters because users may be unable to remove the protector cap from the device.

    Product
    Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: The Peripheral Cutting Balloon Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae. 1) 4.0
    Category
    Distribution
    43 states
  • ModerateFDA (Devices)··2013-09-11

    Boston Scientific Recalls 4.0mm Flextome Cutting Balloon Devices

    Boston Scientific is recalling 4.0mm x 15mm Flextome Cutting Balloon devices because users may be unable to remove the protector cap.

    Product
    Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiation: 1) 4.00mm x 15mm FlextomeTM Cutting BalloonTM MonorailTM Microsurgical Dilatation Device, UPN #H749CBM3400150 Catalogue # CBM340015 & UPN# H749RB4400150 Catalogue # RB440015 2) 4.00mm x 15mm F
    Category
    Distribution
    43 states