Intra-Aortic Balloon (IAB)

• 13 recalls, same reason

  • Terminated Z-1212-2009 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-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-1215-2009 FDA Unclassified (pre-2012) ·initiated 2 Feb 2009
  • Terminated Z-1221-2009 FDA Unclassified (pre-2012) ·initiated 2 Feb 2009
  • Terminated Z-1222-2009 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

K040801 ↗

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. →

• What clinical scenarios is this Intra-Aortic Balloon (IAB) system intended for use in, and how does it work?

  The Intra-Aortic Balloon (IAB) system is designed for use during cardiac and non-cardiac surgical procedures, acute coronary syndrome, and complications of heart failure. It works by positioning a balloon in the descending aorta, which inflates and deflates in sync with the heart’s cycle. This improves blood flow to the heart and body during diastole (when the heart relaxes) and reduces the workload on the heart during systole (when the heart contracts), thereby enhancing cardiac output and perfusion.

• Is this device single-use or reusable, and what does that mean for maintenance and cost?

  The Intra-Aortic Balloon system is supplied as a reusable device, meaning it is intended for repeated use after proper cleaning, disinfection, and maintenance. This design can impact cost over time, as it requires ongoing upkeep rather than replacement after each use, but it may also reduce waste and long-term expenses for facilities with high usage.

• What regulatory pathway was followed for this device’s approval, and which committee was involved?

  This Intra-Aortic Balloon system received FDA clearance through the 510(k) pathway, specifically under the classification of Special and the product code DSP. The device was reviewed by the Cardiovascular (CV) Advisory Committee, which evaluates medical devices related to heart function and circulatory support.

• Are there different sizes or models available for this device, and how might that affect patient selection?

  The provided data does not specify exact sizes or models, but the device is listed with multiple registration numbers, suggesting variations may exist to accommodate different patient anatomies or clinical needs. Facilities should consult the manufacturer’s documentation to determine compatibility with specific patient profiles, as sizing would influence proper placement and effectiveness.

• How should this reusable device be stored to ensure proper functionality and longevity?

  Since the Intra-Aortic Balloon system is reusable, storage instructions would typically include keeping it in a clean, dry environment away from direct sunlight or extreme temperatures. The manufacturer’s guidelines likely outline specific cleaning, disinfection, and maintenance protocols to prevent damage, ensure sterility between uses, and maintain performance over time. Always refer to the provided instructions for storage and handling.