Arrow IPN000255

• FDA 510(k) K000729 decided 19 May 2000 Active
• FDA GUDID UDI-DI 00801902010759 listed 16 Oct 2015 Listed

• 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.

1. 27 Nov 2012 Recall initiated FDA recalls Z-1064-2013
2. 27 Nov 2012 Recall initiated FDA recalls Z-1065-2013
3. 16 Oct 2015 Listed FDA GUDID 00801902010759
4. 10 Feb 2016 Recall initiated FDA recalls Z-1059-2016
5. 10 Feb 2016 Recall initiated FDA recalls Z-1062-2016
6. 10 Feb 2016 Recall initiated FDA recalls Z-1060-2016
7. 10 Feb 2016 Recall initiated FDA recalls Z-1058-2016
8. 10 Feb 2016 Recall initiated FDA recalls Z-1056-2016
9. 29 Apr 2024 Recall initiated FDA recalls Z-1879-2024
10. 29 Apr 2024 Recall initiated FDA recalls Z-1880-2024

19 earlier events are in the sections above.

Trade name

Arrow

Generic name

Intra-aortic balloon catheter

Model / Ref / Catalog

IPN000255, IAB-05840-U

Primary DI / UDI-DI

00801902010759

510(k) Number

K000729 ↗

FDA product code

DSP

GMDN term

Intra-aortic balloon catheter

Device class

Class II

Regulation number

870.3535

GUDID distribution status

In Commercial Distribution

Size

Total Volume — 40 Milliliter

Category: Intra-aortic balloon catheter

Other devices filed under FDA product code DSP (System, balloon, intra-aortic and control).

• ARROW KINK RESISTANT FLEXI-CATH INTRA-AORTIC BALLOON by Arrow Intl., Inc.
• SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE by Abiomed, Inc.
• SUPRACOR BALLOON CATHETER by Abiomed, Inc.
• 8 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON by Kontron Instruments, Inc.
• 40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER by Aries Medical, Inc.
• ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1) by Arrow Intl., Inc.
• CARDIOSAVE HYBRID TYPE D PLUG 0998-00-0800-33 by Datascope Corp.
• PRESSURE TRIGGER MOD OF SMEC INTRA-AORT by Smec, Inc.
• SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER by Boston Scientific
• PECOR, PERCOR-DL, 10.5 FRENCH W/SMEC by Datascope Corp.

• Arrow IPNB00820 Open recall

  Class II

  FDA 510(k) K140110 Active Cleared 27 Mar 2015 GUDID on market

• Arrow IPNB00826 Open recall

  Class II

  FDA 510(k) K140110 Active Cleared 27 Mar 2015 GUDID on market

• Arrow IPNB00822 Open recall

  Class II

  FDA 510(k) K140110 Active Cleared 27 Mar 2015 GUDID on market

• Arrow IPNB00827 Open recall

  Class II

  FDA 510(k) K140110 Active Cleared 27 Mar 2015 GUDID on market

See all devices from Teleflex Incorporated →