UltraFlex IAB: 7.5Fr 40cc recallZ-1060-2016 · Arrow International, Inc., Division of Teleflex Medical Inc. · initiated Feb 10, 2016

Why it was recalled

The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.

FDA root cause category: Process control

What the company is doing

The firm, Teleflex Arrow International, sent an "Urgent Medical Device Recall Notification" letter dated 2/11/2016 via FedEx to its Customers. The letter described the product, problem and actions to be taken. The customers were informed of the reason for recall and were instructed to take the following actions: 1. If you have any products referenced in the attached enclosure, immediately discontinue use and quarantine those products appropriately. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507 Attn: Customer Service or email it to [email protected]. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Arrow International. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to [email protected]. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

Recall details

Recall number

Z-1060-2016

Recall class

Class I (most serious)

Status

Terminated

Initiated by the company

Feb 10, 2016

Posted by the FDA

Mar 11, 2016

Recalling firm

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

Quantity

13,405 US and 33,735 OUS in total

Product code

DSP

FDA submissions

K000729

Distribution

Worldwide Distribution: US (Nationwide) and countries of: Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Bahamas, Canada, Chile, China, Colombia, Ecuador, Guatemala, Hong Kong, Indonesia, India, Japan, Korea (Republic of [South] Korea), Myanmar, Mexico, Malaysia, Nepal, New Zealand, Panama, Peru, Philippines, Pakistan, Singapore, Thailand, Trinidad and Tobago, Taiwan, Uruguay, Viet Nam, and South Africa (Zuid Afrika).

Product description

UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

Other devices under the same FDA submission

13 devices cleared under K000729 — 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 73266).

• Z-1056-2016 · Terminated
  Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diasto…
• Z-1058-2016 · Terminated
  Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diasto…
• Z-1059-2016 · Terminated
  UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during di…
• Z-1061-2016 · Terminated
  RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diasto…
• Z-1062-2016 · Terminated
  Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during di…
• Z-1063-2016 · Terminated
  Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during dia…