Cardioplegia cannula AR-xxxxx (UDI 00803622103094)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00803622103094), received between Jul 31, 2019 and Nov 14, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556413 ↗
• MalfunctionJul 31, 2019Disconnection; Disconnection

  LIVANOVA RECEIVED A REPORT THAT, AFTER THE INSERTION OF THE AORTIC ROOT CANNULA IN THE AORTA, THE PLASTIC CAP THAT HELPS TO EXTRACT THE INTERNAL GUIDEWIRE DETACHED FROM THE GUIDEWIRE. THE SURGEON COULD REMOVE THE GUIDEWIRE WITH THE HELP OF A TOOL. THERE WAS NO REPORT OF PATIENT INJURY. THE USER BELIEVES THIS MIGHT CAUSE A RISK FOR THE SURGEON WHILE REMOVING DETACHED GUIDEWIRE. ON THE SAME DATE, A SIMILAR EVENT OCCURRED WHILE USING A CANNULA OF THE SAME LOT OF THE PRESENT REPORT (LIVANOVA REFERENCE (B)(4)).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8844704 ↗
• MalfunctionJul 31, 2019Disconnection; Disconnection

  LIVANOVA RECEIVED A REPORT THAT, AFTER THE INSERTION OF THE AORTIC ROOT CANNULA IN THE AORTA, THE PLASTIC CAP THAT HELPS TO EXTRACT THE INTERNAL GUIDEWIRE DETACHED FROM THE GUIDEWIRE. THE SURGEON COULD REMOVE THE GUIDEWIRE WITH THE HELP OF A TOOL. THERE WAS NO REPORT OF PATIENT INJURY. THE USER BELIEVES THIS MIGHT CAUSE A RISK FOR THE SURGEON WHILE REMOVING DETACHED GUIDEWIRE. ON THE SAME DATE, A SIMILAR EVENT OCCURRED WHILE USING A CANNULA OF THE SAME LOT OF THE PRESENT REPORT (LIVANOVA REFERENCE (B)(4)).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8844698 ↗

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