Catheters for Balloon Occlusion Femoral Angiograph

• 2 recalls, same reason

  • Terminated Z-0716-2020 FDA Class II ·initiated 15 Nov 2019
  • Terminated Z-0715-2020 FDA Class II ·initiated 15 Nov 2019

  Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowly following placement. If the leak went undetected by attending clinicians during use, it could result in contrast injection into the vascular or cardiac tissue which could result in serious injury or death

• • Terminated Z-1057-2013 FDA Class II ·initiated 4 Mar 2013

  The product specifications sheet, part of the Instructions for Use (IFU), for the specified product numbers, reference Renografin-76 contrast medium (viscosity of 8.4 centipoise), which is no longer available. Firm is in the process of updating the labeling for these products. In the meantime, when choosing an alternative contrast medium, health care providers are instructed to select a contrast

510(k) Number

K892530 ↗

FDA Product Code

DYG

Device Class

Class II

Regulation

21 CFR Part 870.1240

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• Needleless Injection Cannula

  Class II

  FDA 510(k) K923653 Active Cleared 13 May 1993

• Arrow Echogenic Introducer Needle Component

  Class II

  FDA 510(k) K071998 Active Cleared 26 Sep 2007

See all devices from Arrow Intl., Inc. →