DLP® 20114WFRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20613994495383), received between Feb 8, 2022 and Oct 23, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 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, 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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE SUTURE COLLAR OF THE DLP AORTIC ROOT CANNULA WITH A VENT LINE BECAME LOOSE AND SEPARATED, BECOMING DISLODGED WHEN ATTEMPTING TO SUTURE THE CANNULA IN PLACE IN THE AORTA DURING USE. THE LOOSE/SEPARATED COMPONENT DID NOT FALL INTO THE PATIENT. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23366397 ↗
• MalfunctionOct 23, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE SUTURE COLLAR OF THE DLP AORTIC ROOT CANNULA WITH A VENT LINE BECAME LOOSE AND SEPARATED, BECOMING DISLODGED WHEN ATTEMPTING TO SUTURE THE CANNULA IN PLACE IN THE AORTA DURING USE. THE LOOSE/SEPARATED COMPONENT DID NOT FALL INTO THE PATIENT. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23366149 ↗
• MalfunctionMay 16, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP AORTIC ROOT CANNULA WITH VENT LINE, IT WAS REPORTED THAT THE SUTURE FLANGE DISLODGED FROM THE BODY OF THE CANNULA AFTER BEING PLACED IN THE AORTA. THE COMPONENT DID NOT FALL INTO THE PATIENT. 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 22033714 ↗
• MalfunctionFeb 18, 2022Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE USE OF A DLP AORTIC ROOT CANNULA WITH VENT LINE, THE CUSTOMER REPORTED THAT THE FLANGE OF THE CANNULA BECAME DISCONNECTED FROM THE BODY OF THE CANNULA. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13557004 ↗
• MalfunctionFeb 8, 2022Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP AORTIC ROOT CANNULA WITH VENT LINE, THE CUSTOMER REPORTED ONCE THE CANNULA WAS INSERTED INTO THE ASCENDING AORTA AND SUTURED INTO PLACE USING THE FLANGE, THE FLANGE BECAME DETACHED FROM THE BODY OF THE CANNULA. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13477706 ↗