Cardioplegia cannulaRecalls & reported problems across all models
Livanova USA, Inc. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 6 models of Cardioplegia cannula by Livanova USA, Inc. in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Jan 17, 2018 and Nov 14, 2025 — classified as 3 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Disconnection” (13 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Cardioplegia cannula problems
Device problems
- Disconnection13
- Detachment of Device or Device Component3
- Material Twisted/Bent2
- Defective Component1
- Increase in Pressure1
- Material Deformation1
- Material Too Rigid or Stiff1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Consequences Or Impact To Patient6
- No Patient Involvement4
- Foreign Body In Patient1
- Insufficient Information1
- Patient Problem/Medical Problem1
Cardioplegia cannula models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Cardioplegia cannula AR-xxxxxCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS6 reports
- Cardioplegia cannula AR-xxxxxCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS6 reports
- Cardioplegia cannula AR-xxxxxCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS3 reports
- Cardioplegia cannula AR-xxxxxCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS2 reports
- Cardioplegia cannula AR-xxxxxCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS2 reports
- Cardioplegia cannula AR-xxxxxCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
Recent Cardioplegia cannula adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryDec 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
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 ↗InjuryJan 3, 2024Defective Component; Defective Component
LIVANOVA USA RECEIVED A REPORT THAT SURGEON WAS USING THE AR-11112 AND WAS GOT STUBBED USING THE STEEL INTRODUCER NEEDLE. THERE IS NO REPORT OF ANY PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18433430 ↗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 ↗MalfunctionMar 17, 2023Disconnection; Disconnection
LIVANOVA USA WAS INFORMED THAT, DURING THE IMPLANTATION OF THE NEEDLE OF THE CARDIOPLEGIA CANNULA, THE TEFLON OF THE NEEDLE IS RETRACTED IN TWO ATTEMPTS. AFTER THE SECOND ATTEMPT, THE SURGEON DECIDES TO CHANGE THE NEEDLE TO ANOTHER MEDICAL DEVICE. THE PROCEDURE WAS COMPLETED WITH NO ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16563370 ↗MalfunctionJun 22, 2021Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
MalfunctionMay 28, 2021Disconnection; Disconnection
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11899593 ↗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 ↗MalfunctionJun 4, 2020Disconnection; Disconnection
LIVANOVA USA IN HAS RECEIVED A REPORT THAT, DURING A PROCEDURE, THE AORTIC ROOT CARDIOPLEGIA CANNULA NECESSITATE TO BE MODIFIED TO REMAIN CONNECTED. THE CUSTOMER REPORTED THIS COULD HAVE CAUSED HEMORRHAGE. THERE IS NO REPORT OF ANY PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10118415 ↗MalfunctionNov 11, 2019Disconnection; Disconnection
LIVANOVA USA INC HAS BEEN INFORMED THAT, DURING A PROCEDURE, THE LUERLOCK CONNECTION HAS DETACHED FROM THE SKEWER DURING THE APPLICATION. THERE IS NOT REPORT OF ANY PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9303545 ↗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 ↗
Other Livanova USA, Inc. products
All Livanova USA, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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