DLP® 20012SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20613994495529), received between Jul 11, 2022 and Jul 19, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 19, 2022Material Separation; Material Deformation; Material Separation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP AORTIC ROOT CANNULA WITH VENT LINE, THE CUSTOMER REPORTED THAT IT WAS IMPOSSIBLE TO UNSCREW THE METAL CONDUCTOR IN THE PROXIMAL PART, THE CUSTOMER STATED THAT "IT IS SOLDERED". THE CARDIAC SURGEON TRIED TO CARRY OUT THIS PROCEDURE WITH CLAMPS, SO THERE ARE MECHANICAL DAMAGES ON THE CANNULA. THE ATTEMPT WAS UNSUCCESSFUL. THE CANNULA WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15050208 ↗
• MalfunctionJul 19, 2022Material Separation; Material Deformation; Material Separation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP AORTIC ROOT CANNULA WITH VENT LINE, THE CUSTOMER REPORTED THAT IT WAS IMPOSSIBLE TO UNSCREW THE METAL CONDUCTOR IN THE PROXIMAL PART, THE CUSTOMER STATED THAT "IT IS SOLDERED". THE CARDIAC SURGEON TRIED TO CARRY OUT THIS PROCEDURE WITH CLAMPS, SO THERE ARE MECHANICAL DAMAGES ON THE CANNULA. THE ATTEMPT WAS UNSUCCESSFUL. THE CANNULA WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15049959 ↗
• MalfunctionJul 11, 2022Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP AORTIC ROOT CANNULAE WITH VENT LINE, IT WAS REPORTED ONE OF THE FLANGES ON THE SEWING RING LOOKED SHARP AND MIS-SHAPED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE 4 AREAS OF THE SEWING FLANGE WERE NOT EVEN. ONE LOOKS AS IF IT WAS CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14977098 ↗