AORTIC ARCH CANNULA, Catheter, Cannula And Tubing… recallZ-2147-2016 · Sorin Group USA, Inc. · initiated Jun 22, 2016

Why it was recalled

Sorin Group USA is recalling Aortic Arch Cannulae (part numbers NA-55X7 and NA-55X8) because the distal end may be less than specified. The defective cannula are showing an angle that is about 15-20 degrees instead of approximately 45 degrees.

FDA root cause category: Process control

What the company is doing

The firm, LivaNova, sent an "Urgent Safety Alert" field communication letter dated June 22, 2016 via certified mail to consignees. The letter described the product, problem and actions to be taken. The consignees were instructed to: check your inventory to determine if you own Cannulae, if no inventory, complete the response form and return it per instructions indicated on form.; check the tip angle to determine if it is conforming to specifications, if specifications not met, file a complaint through your normal process whether you decide to keep it, use it or return it to Sorin Group; If you are not willing to use it, return affected product parts to Sorin Group USA,; contact Customer Service at 1-800-650-2623 or email CustomerService@livanova,com to have a RMA issued, and complete and return the Customer Response Form no later than July 20, 2016 via Fax at 303-467-6502 or by e-mail to [email protected]. If you need support for the execution of these actions, please contact your LivaNova sales representative or call Customer Service at 1-800-650-2623 (Monday to Friday 8AM to 5PM MT). For questions regarding this notice, please contact Customer Service at 1-800-650-2623 (Monday to Friday 8AM to 5PM MT) or e-mail [email protected].

Recall details

Recall number

Z-2147-2016

Recall class

Class II

Status

Terminated

Initiated by the company

Jun 22, 2016

Posted by the FDA

Jul 8, 2016

Recalling firm

Sorin Group USA, Inc.

Quantity

5740

Product code

DWF

FDA submissions

K943934

Distribution

Worldwide Distribution: US (nationwide) to states of: LA, Ml, MO, OH, TN, and TX; and countries of: Italy and Canada.

Product description

AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.

Other devices under the same FDA submission

7 devices cleared under K943934 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• Arterial cardiopulmonary bypass cannula RA-xxxxx

  Livanova USA, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  3 reports
• Arterial cardiopulmonary bypass cannula RA-xxxxx

  Livanova USA, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  2 reports
• Venous cardiopulmonary bypass cannula LR-xxxxx

  Livanova USA, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  1 report
• Venous cardiopulmonary bypass cannula LR-xxxxx

  Livanova USA, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  1 report
• Arterial cardiopulmonary bypass cannula NA-xxxxx

  Livanova USA, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  1 report
• Arterial cardiopulmonary bypass cannula RA-xxxxx

  Livanova USA, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  1 report
• Venous cardiopulmonary bypass cannula RT-xxxxx

  Livanova USA, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  1 report