Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr… recallZ-0791-2011 · Arrow International, Inc., Division of Teleflex Medical Inc. · initiated Oct 11, 2010

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

Arrow international initiated a voluntary recall on 12/21/10 by letter requesting users to discontinue use and return all unused 5800 Series IAB with SuperFlex Introducers to Arrow. This field action supercedes the Safety Alert IAB 'Stuck in Sheath' letter issued on 10/8/2010. Questions should be directed towards their local sales representative or the IABP support Line at 1-866-396-2111 or 1-617-389-6400.

Recall details

Recall number

Z-0791-2011

Recall class

Not yet classified by the FDA

Status

Terminated

Initiated by the company

Oct 11, 2010

Posted by the FDA

Dec 23, 2010

Recalling firm

Arrow International, Inc., Division of Teleflex Medical Inc.

Quantity

13, 391 units

Product code

DSP

FDA submissions

K000729, K021462

Distribution

Worldwide Distribution -- USA, Canada, Australia, Belgium, Czechoslovakia, Germany, Russia, Spain, Finland, France, Great Britain, Hungary, Italy, Netherlands, Poland, Saudi Arabia, Switzerland, Brazil, Australia, Chile, Colombia, Ecuador, India, Indonesia, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Peru, Philippines, Taiwan, Thailand, and Venezuela.

Product description

Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 40cc. Model: IAB-05840-U

Other devices under the same FDA submission

13 devices cleared under K000729, K021462 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• ARROW IPN000260

  Teleflex Incorporated · System, balloon, intra-aortic and control
  4 deaths698 reports
• ARROW IPN000257

  Teleflex Incorporated · System, balloon, intra-aortic and control
  3 deaths233 reports
• ARROW IPN915322

  Teleflex Incorporated · System, balloon, intra-aortic and control
  1 recall29 reports
• ARROW IPN039793

  Teleflex Incorporated · System, balloon, intra-aortic and control
  62 reports
• ARROW IPN915321

  Teleflex Incorporated · System, balloon, intra-aortic and control
  1 recall7 reports
• ARROW IPN915320

  Teleflex Incorporated · System, balloon, intra-aortic and control
  1 recall0 reports
• ARROW IPN000255

  Teleflex Incorporated · System, balloon, intra-aortic and control
  32 reports
• ARROW IPN039788

  Teleflex Incorporated · System, balloon, intra-aortic and control
  29 reports
• ARROW IPN039782

  Teleflex Incorporated · System, balloon, intra-aortic and control
  23 reports
• ARROW IPN039778

  Teleflex Incorporated · System, balloon, intra-aortic and control
  16 reports
• ARROW IPN038075

  Teleflex Incorporated · System, balloon, intra-aortic and control
  12 reports
• ARROW IPN038074

  Teleflex Incorporated · System, balloon, intra-aortic and control
  7 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 56965).

• Z-0790-2011 · Terminated
  Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 30cc. Model: IAB-05830-U
• Z-0792-2011 · Terminated
  FiberOptix IAB Sheath, Ultra 8 Fr, 30cc. Model: IAB-05830-LWS
• Z-0793-2011 · Terminated
  FiberOptix IAB Ultra 8 Fr, 40cc Model: IAB-05840-LWS
• Z-0969-2011 · Terminated
  Percutaneous Insertion Tray For Use with: Arrow Ultra 8 IAB (Intra Aortic Balloon) Catheters Model: IAK-05845