Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a Measurement System, Models Iab-05830-F, IAB5840

• 2 recalls, same reason

  • Terminated Z-1055-2016 FDA Class I ·initiated 10 Feb 2016
  • Terminated Z-1057-2016 FDA Class I ·initiated 10 Feb 2016

  The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.

• • Terminated Z-1233-2015 FDA Class II ·initiated 5 Feb 2015

  Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rather than the correct FiberOptix IAB 8Fr

• • Terminated Z-1259-2015 FDA Class II ·initiated 8 Nov 2013

  Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere.

• 2 recalls, same reason

  • Terminated Z-1065-2013 FDA Class II ·initiated 27 Nov 2012
  • Terminated Z-1064-2013 FDA Class II ·initiated 27 Nov 2012

  Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter.

• 5 recalls, same reason

  • Terminated Z-0790-2011 FDA Unclassified (pre-2012) ·initiated 11 Oct 2010
  • Terminated Z-0792-2011 FDA Unclassified (pre-2012) ·initiated 11 Oct 2010
  • Terminated Z-0969-2011 FDA Unclassified (pre-2012) ·initiated 11 Oct 2010
  • Terminated Z-0793-2011 FDA Unclassified (pre-2012) ·initiated 11 Oct 2010
  • Terminated Z-0791-2011 FDA Unclassified (pre-2012) ·initiated 11 Oct 2010

  SuperArrow Flex IAB catheter becomes stuck in the sheath, unable to move the IAB catheter forward or backward, causing a delay in therapy, bleeding or arterial injury.

• 13 recalls, same reason

  • Terminated Z-1222-2009 FDA Unclassified (pre-2012) ·initiated 2 Feb 2009
  • Terminated Z-1212-2009 FDA Unclassified (pre-2012) ·initiated 2 Feb 2009
  • Terminated Z-1221-2009 FDA Unclassified (pre-2012) ·initiated 2 Feb 2009
  • Terminated Z-1220-2009 FDA Unclassified (pre-2012) ·initiated 2 Feb 2009
  • Terminated Z-1214-2009 FDA Unclassified (pre-2012) ·initiated 2 Feb 2009
  • Terminated Z-1213-2009 FDA Unclassified (pre-2012) ·initiated 2 Feb 2009
  • Terminated Z-1211-2009 FDA Unclassified (pre-2012) ·initiated 2 Feb 2009
  • Terminated Z-1217-2009 FDA Unclassified (pre-2012) ·initiated 2 Feb 2009
  • Terminated Z-1219-2009 FDA Unclassified (pre-2012) ·initiated 2 Feb 2009
  • Terminated Z-1218-2009 FDA Unclassified (pre-2012) ·initiated 2 Feb 2009
  • Terminated Z-1216-2009 FDA Unclassified (pre-2012) ·initiated 2 Feb 2009
  • Terminated Z-1210-2009 FDA Unclassified (pre-2012) ·initiated 2 Feb 2009
  • Terminated Z-1215-2009 FDA Unclassified (pre-2012) ·initiated 2 Feb 2009

  A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume.

510(k) Number

K021462 ↗

FDA Product Code

DSP

Device Class

Class II

Regulation

21 CFR Part 870.3535

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Brachial Plexus Catheter - Bp-01200

  Class II

  FDA 510(k) K874105 Active Cleared 24 Nov 1987

• A2 Port, Dual Lumen System With Detached Catheter, Catalog # AP-01518

  Class II

  FDA 510(k) K963684 Active Cleared 24 Oct 1996

• Arrow Picc-Peripherally Inserted Central Catheter

  Class II

  FDA 510(k) K930129 Active Cleared 28 Mar 1994

• Hemosonic 200HEMODYNAMIC Monitor

  Class II

  FDA 510(k) K040802 Active Cleared 28 Apr 2004

• 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

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