AC3 Series IABP System

• 2 recalls, same reason

  • Terminated Z-2416-2020 FDA Class I ·initiated 20 May 2020
  • Terminated Z-2417-2020 FDA Class I ·initiated 20 May 2020

  A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of motor connector wires, which may result in pump alarms for System Error 3 and High Baseline presented on the screen of the IABP, and potential abrupt cessation of function or inability to start the IABP.

510(k) Number

K162820 ↗

FDA Product Code

DSP

Device Class

Class II

Regulation

21 CFR Part 870.3535

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• UltraFlex IAB Open recall

  Class II

  FDA 510(k) K190101 Active Cleared 28 Jun 2019

• Silicone Coated Guidewire

  Class II

  FDA 510(k) K041740 Active Cleared 15 Oct 2004

• Cg+ Arrow Picc Powered by Arrow Vps Stylet Open recall

  Class II

  FDA 510(k) K130876 Active Cleared 26 Apr 2013

• Arrow, Arrowg+ard and Arrowg+ard Blue Plus Pressure Injectable Central Venous Catheter Open recall

  Class II

  FDA 510(k) K071538 Active Cleared 30 Aug 2007

• Step-Tip Chronic Hemodialysis Catheter

  Class II

  FDA 510(k) K040666 Active Cleared 14 May 2004

• Fiberoptix IAB

  Class II

  FDA 510(k) K190117 Active Cleared 13 Jun 2019

See all devices from Arrow International, Inc. →