Cardioplegia cannula AR-xxxxx (UDI 00803622103001)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00803622103001), received between Aug 23, 2019 and Apr 30, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Disconnection” (6 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.

• MalfunctionApr 30, 2024Disconnection; Disconnection

  LIVANOVA USA RECEIEVED A REPORT THAT DURING A PROCEDURE, THE DISTAL P PLASTIC CAP OF THE METAL NEEDLE OF THE AORTING CANNULA CAME OFF WHEN INSERTED. THIS CAUSED PATIENT TO HAVE BLOOD LOSS FROM AORTA. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19212229 ↗
• MalfunctionMay 28, 2021Disconnection; Disconnection

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11899593 ↗
• MalfunctionOct 17, 2019Disconnection; Disconnection

  LIVANOVA USA INC HAS BEEN INFORMED THAT, DURING A PROCEDURE, THE CAP THAT HELPS TO EXTRACT THE METAL NEEDLE INSIDE THE AORTIC ROOT CANNULA DETACHES FROM THE METAL NEEDLE. THERE IS NOT REPORT OF ANY PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9201244 ↗
• MalfunctionOct 17, 2019Disconnection; Disconnection

  LIVANOVA USA INC HAS BEEN INFORMED THAT THE CAP THAT HELP TO EXTRACT THE METAL NEEDLE INSIDE THE AORTIC ROOT CANNULA DETACHES FROM THE METAL NEEDLE. THE ISSUE OCCURRED AT SETUP, PRIOR TO ANY PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9201229 ↗
• MalfunctionOct 17, 2019Disconnection; Disconnection

  LIVANOVA USA INC HAS BEEN INFORMED THAT THE CAP THAT HELP TO EXTRACT THE METAL NEEDLE INSIDE THE AORTIC ROOT CANNULA DETACHES FROM THE METAL NEEDLE. THE ISSUE OCCURRED AT SETUP, PRIOR TO ANY PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9201227 ↗
• MalfunctionAug 23, 2019Disconnection; Disconnection

  LIVANOVA USA INC HAS BEEN INFORMED THAT DURING A PROCEDURE, THE DISTAL END LUER LOCK OF THE AORTIC ROOT CANNULA SEPARATED FROM THE REST OF THE CANNULA AND BLOOD WAS SPAYED OVER THE DRAPES AND THE PUMP. THERE IS NO REPORT OF ANY PATIENT/USER INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8924372 ↗

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