Cardioplegia cannula AR-xxxxx (UDI 00803622103049)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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00803622103049), received between Nov 11, 2019 and Jan 3, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Defective Component” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Defective Component1
- Disconnection1
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.
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 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 ↗
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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