Arrow IPN038074

• EUDAMED Basic UDI-DI B-00801902136701 registered 4 Aug 2026 Active
• FDA 510(k) K000729 decided 19 May 2000 Active
• FDA GUDID UDI-DI 00801902136701 listed 6 Dec 2018 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-1065-2013
2. 10 Feb 2016 Recall initiated FDA recalls Z-1059-2016
3. 10 Feb 2016 Recall initiated FDA recalls Z-1062-2016
4. 10 Feb 2016 Recall initiated FDA recalls Z-1060-2016
5. 10 Feb 2016 Recall initiated FDA recalls Z-1058-2016
6. 10 Feb 2016 Recall initiated FDA recalls Z-1056-2016
7. 6 Dec 2018 Listed FDA GUDID 00801902136701
8. 29 Apr 2024 Recall initiated FDA recalls Z-1879-2024
9. 29 Apr 2024 Recall initiated FDA recalls Z-1880-2024
10. 4 Aug 2026 Registered EUDAMED B-00801902136701

20 earlier events are in the sections above.

Trade name

UltraFlex(TM) IAB EUDAMED

Arrow GUDID

Generic name

Intra-aortic balloon catheter

Device name

UltraFlex IAB: 7.5Fr 30cc

Model / Ref / Catalog

IAB-06830-U, IPN038074

Primary DI / UDI-DI

00801902136701

Basic UDI-DI

B-00801902136701

510(k) Number

K000729 ↗

FDA product code

DSP

EMDN code

C019001 Aortic counterpulsation catheters

GMDN term

Intra-aortic balloon catheter

Device class

Class III EUDAMED

Class II GUDID

Regulation number

870.3535

EU registration type

Legacy device (under a directive)

EU market of registration

Ireland

GUDID distribution status

In Commercial Distribution

Size

Catheter Gauge — 7.5 French

Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Category: Intra-aortic balloon catheter

Other devices filed under DEVICES FOR VASCULAR PROCEDURES - VARIOUS.

• FiberOptix(R) IAB IAB-05840-LWS by Arrow International LLC (Subsidiary of Teleflex Incorporated)
• Intra-aortic balloon catheter set IABC7.5F40 by Balton Sp. z o.o.
• Intra-aortic balloon catheter set IABC7.5F30 by Balton Sp. z o.o.
• FiberOptix(R) IAB IAB-05830-LWS by Arrow International LLC (Subsidiary of Teleflex Incorporated)
• Syntel Silicone OTW Embolectomy Catheter A4E08 by LeMaitre Vascular, Inc.
• LeMaitre Embolectomy Catheter 1801-26 by LeMaitre Vascular, Inc.
• Glutton 6F-115S by NeuroSafe Medical Co., Ltd.
• FlowTriever Catheter 10-102 by Inari Medical, Inc.
• Embolectomy Catheter EL1540 23-000006-21 by BIOPTIMAL INTERNATIONAL PTE. LTD.
• Bioptimal Embolectomy Catheter 23-000006-18 by Bioptimal International Pte. Ltd.

• 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 →