Arrow Ultra 8 Intra-Aortic Balloon Catheters (Iabs) 8Fr 30cc and 40cc Universal

• 2 recalls, same reason

  • Ongoing Z-1879-2024 FDA Class I ·initiated 29 Apr 2024
  • Ongoing Z-1880-2024 FDA Class I ·initiated 29 Apr 2024

  Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.

• 5 recalls, same reason

  • Terminated Z-1059-2016 FDA Class I ·initiated 10 Feb 2016
  • Terminated Z-1062-2016 FDA Class I ·initiated 10 Feb 2016
  • Terminated Z-1060-2016 FDA Class I ·initiated 10 Feb 2016
  • Terminated Z-1058-2016 FDA Class I ·initiated 10 Feb 2016
  • Terminated Z-1056-2016 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.

• 2 recalls, same reason

  • Terminated Z-1064-2013 FDA Class II ·initiated 27 Nov 2012
  • Terminated Z-1065-2013 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-0792-2011 FDA Unclassified (pre-2012) ·initiated 11 Oct 2010
  • Terminated Z-0969-2011 FDA Unclassified (pre-2012) ·initiated 11 Oct 2010
  • Terminated Z-0790-2011 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-1215-2009 FDA Unclassified (pre-2012) ·initiated 2 Feb 2009
  • Terminated Z-1222-2009 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-1212-2009 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

K000729 ↗

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

See all devices from Arrow Intl., Inc. →