Arterial cardiopulmonary bypass cannula RA-xxxxx (UDI 00803622105050)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00803622105050), received between Dec 16, 2020 and Sep 14, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Disconnection” (3 reports).

4 other recalls cover devices cleared under the same FDA submission (K943934); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2022Disconnection; Disconnection

  LIVANOVA USA INC HAS RECEIVED A REPORT THAT THE TIP OF THE AORTIC DISCONNECTED FROM THE BODY OF THE CANNULA AT THE END OF A SURGERY THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15415982 ↗
• MalfunctionJan 14, 2021Disconnection; Disconnection

  SEE INITIAL REPORT.

  Patient problems: No Patient Involvement

  MAUDE report 11169030 ↗
• MalfunctionDec 16, 2020Disconnection; Disconnection

  LIVANOVA USA INC HAS RECEIVED A REPORT THAT, AT THE END OF THE PROCEDURE, THE TIP OF THE AORTIC CANNULA DISCONNECTED FROM THE BODY OF THE CANNULA. THERE IS NOT REPORT OF ANY PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11019095 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K943934. One submission often covers many models, so check the product and lot details in each record.

• Z-2871-2017 · Jun 9, 2017 · Terminated
  Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during c
• Z-2756-2016 · Aug 12, 2016 · Terminated
  Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during c
• Z-2147-2016 · Jun 22, 2016 · Terminated
  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 extracor
• Z-0813-2016 · Jan 25, 2016 · Terminated
  Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product is packed in a sealed pouch, ten (10) po