Cardioplegia cannula AR-xxxxx (UDI 00803622103018)Recalls & reported problems
Livanova USA, Inc. · Class 2
All models of Cardioplegia cannula (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00803622103018), received between Jun 4, 2020 and Mar 17, 2023 — classified as 2 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
Device problems
- Disconnection2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 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 ↗
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 · TerminatedCoronary 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
Other CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS devices
- DLP™ 77010Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall154 reports
- EOPA™ 77422Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls19 reports
- DLP™ 77008Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls9 reports
- NA HY11W65R1Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls8 reports
- DLP® 12113Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls6 reports
- DLP® Aortic Root Cannula with Flow-Guard™ 11012Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS2 recalls5 reports
- EOPA™ 77622Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls4 reports
- NA HY2V10R33Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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