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DLP® 20009Recalls & reported problems

Medtronic, Inc. · CANNULA 20009 AR VENT LINE 9GA 20PK 17L · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20613994495666), received between May 22, 2019 and May 22, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Physical Resistance/Sticking1

Patient problems

  • Laceration(s)1
  • Tissue Damage1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 22, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE, THE CUSTOMER REPORTED DIFFICULTY REMOVING THE 20009 AORTIC ROOT CANNULA MANDREL TO ALLOW INSERTION INTO THE AORTA. THE CANNULA REMAINED STUCK TO THE MANDREL WITH ONE END STILL IN THE AORTA. NO DAMAGE WAS NOTED TO THE CANNULA OR ITS PACKAGING. THE PRODUCT WAS REPLACED TO COMPLETE THE CASE. IT NECESSITATED SUTURE CLOSURE AND REQUIRED A SECOND HOLE TO BE MADE IN THE PATIENT'S AORTA FOR CANNULATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Patient problems: Laceration(s); Tissue Damage

    MAUDE report 8630955 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.