DLP® 10218Recalls & reported problems
Medtronic, Inc. · CANNULA 10218 AR 18GA WHITE TIP 20PK 17L · Class 2
All models of DLP (151)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20613994540113), received between May 23, 2017 and Dec 4, 2024 — classified as 1 death, 1 malfunction.
The most frequently reported specific device problem is “Air Leak” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Air Leak1
- Air/Gas in Device1
- Fluid/Blood Leak1
- Material Separation1
Patient problems
- Death1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 4, 2024Fluid/Blood Leak; Material Separation; Air/Gas in Device; Fluid/Blood Leak; Material Separation; Air/Gas in Device
MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP AORTIC ROOT CANNULA, IT WAS REPORTED THAT THERE WAS A DISCONNECT OF THE MAIN CANNULA BODY NOTED AT THE CONNECTION POINT OF THE LUER ADAPTOR. THERE WAS LEAKING AT THE JOINT WHERE THE HARD PLASTIC MEETS THE SOFT. THE CUSTOMER NOTICED AIR WAS ENTERING THE CANNULA WHERE THE HARD LUER NORMALLY JOINS THE SOFT TUBING OF THE BODY OF THE CANNULA WHILST SUCKING ON THE AORTIC ROOT. NO AIR WAS OBSERVED TO BE ENTRAINED INTO THE CANNULA DURING FORWARD FLOW. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20841827 ↗DeathMay 23, 2017Air Leak; Air Leak
MEDTRONIC RECEIVED INFORMATION THAT DURING THE DELIVERY OF CARDIOPLEGIA WITH THIS CANNULA, THE CUSTOMER NOTED ENTRAINMENT OF AIR. THE DEVICE WAS REPLACED WITH ANOTHER CANNULA FROM THE SAME LOT, BUT THE SAME ISSUE WAS NOTED. THE CUSTOMER LATER NOTED THE UPPER CONNECTION PORT ON THE CANNULA COULD EASILY BE SEPARATED FROM THE TIP. THE PATIENT PASSED AWAY ONE DAY AFTER THE CASE.
Patient problems: Death
MAUDE report 6586241 ↗
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- 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 HY11R00R6Medtronic, 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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