Cardioplegia cannula AR-xxxxx (UDI 00803622103056)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00803622103056), received between Jan 17, 2018 and Nov 15, 2023 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Disconnection” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K972503); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18139449 ↗
• MalfunctionMay 9, 2023Increase in Pressure; Material Twisted/Bent; Increase in Pressure; Material Twisted/Bent

  LIVA NOVA USA INC HAS RECEIVED A REPORT THAT, DURING PROCEDURE, WHEN INJECTING CARDIOPLEGIA SOLUTION IN THE PATIENT'S AORTIC ROOT, THE PERFUSIONIST DETECTED UNUSUAL HIGH PRESSURE ABOVE 600 MMHG. INJECTION WAS STOPPED. A SECOND CARDIOPLEGIA INJECTION ATTEMPT CONFIRMED THE HYPERTENSION. MEDICAL TEAM ELECTED TO CHANGE OUT THE CARDIOPLEGIA CANNULA. THE PROCEDURE WAS COMPLETED WITH NO ISSUE. AFTER REMOVAL OF THE CANNULA, A WATER INJECTION INTO THE CANNULA SHOWED A REFLUX ON THE LATERAL LINE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16893618 ↗
• MalfunctionJun 22, 2021Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  SEE INTIAL REPORT.

  Patient problems: Insufficient Information

  MAUDE report 12041599 ↗
• MalfunctionSep 18, 2020Disconnection; Disconnection

  LIVANOVA USA INC HAS BEEN INFORMED THAT, DURING PRIMING, THE LUERLOCK CONNECTION HAS DETACHED FROM THE SKEWER. THERE IS NOT REPORT OF ANY PATIENT INJURY.

  Patient problems: No Patient Involvement

  MAUDE report 10554121 ↗
• MalfunctionAug 27, 2020Disconnection; Disconnection

  LIVANOVA USA INC HAS BEEN INFORMED THAT, DURING A PROCEDURE, THE LUERLOCK CONNECTION HAS DETACHED FROM THE SKEWER. THERE IS NOT REPORT OF ANY PATIENT INJURY.

  Patient problems: No Patient Involvement

  MAUDE report 10458332 ↗
• InjuryJan 17, 2018Material Too Rigid or Stiff; Material Too Rigid or Stiff

  LIVANOVA RECEIVED A REPORT THAT THE AORTIC ROOT CANNULA CAUSED TRAUMA TO THE PATIENT'S AORTA. DURING FURTHER COMMUNICATION, IT WAS REVEALED THAT THE USER FEELS THE MATERIAL IS HARD AND THE AORTA IS "CRUSHED" WHEN THE CANNULA IS ATTACHED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7198694 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K972503. One submission often covers many models, so check the product and lot details in each record.

• Z-2757-2016 · Aug 12, 2016 · Terminated
  Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery Perfusion Cannula with Balloon The Cannula consists of a single lumen vinyl tube provided