DLP® 20012Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 20613994495505), received between Aug 30, 2018 and Apr 14, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Crack; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP AORTIC ROOT CANNULA WITH VENT LINE, THE CUSTOMER REPORTED A CRACK/BREAK/HOLE AT THE CANNULA TIP. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24871089 ↗
• MalfunctionJan 16, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP AORTIC ROOT CANNULA WITH VENT LINE, IT WAS REPORTED THAT THERE WAS A PACKAGE CONTAMINATION ISSUE. THE USE OF THE DEVICE WAS UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24091396 ↗
• MalfunctionOct 23, 2025Packaging Problem; Packaging Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP AORTIC ROOT CANNULA WITH VENT LINE, IT WAS REPORTED WHEN THE CUSTOMER OPENED THE STERILIZATION PACKAGE, THEY FOUND THAT IT WAS NOT COMPLETELY SEALED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23365830 ↗
• MalfunctionMay 17, 2024Mechanical Problem; Material Separation; Mechanical Problem; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP¿ AORTIC ROOT CANNULAE WITH VENT LINE, IT WAS REPORTED THAT THE NEEDLE WOULD NOT PROPERLY UNSHEATHE OR REMOVE (SCREW OFF) FROM THE LUER PORTION OF THE CANNULA. THE HCP STATED THAT APPARENTLY, THE LUER PORT ON THE NEEDLE AS IMPROPERLY BONDED. 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 19340494 ↗
• MalfunctionDec 11, 2023Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP AORTIC ROOT CANNULA WITH A VENT LINE, THE CUSTOMER REPORTED THAT THE DEVICE MALFUNCTIONED AND WOULD NOT COME OUT. THE CUSTOMER STATED THAT IT APPEARED LIKE SOMETHING WAS BROKEN WITHIN THE LUER LOCK.  THE ISSUE WAS DISCOVERED WHEN CANNULATING, BUT BEFORE BYPASS WAS INITIATED. THERE WAS NO EVIDENCE OF PACKAGING DAMAGE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE SITUATION WITH THE CANNULA OCCURRED DURING INSERTION OF THE CANNULA IN THE PATIENT PRIOR TO GOING ON BYPASS. A FEW MINUTES WENT BY AND THE CUSTOMER REMOVED IT ENTIRELY AND ASKED FOR A NEW ANTEGRADE NEEDLE (SAME PRODUCT AND LOT). THERE WAS NO KNOWN ISSUE WITH THAT DEVICE. THERE WAS NO KNOWN COMPLICATIONS OR IMPACT ON THE PATIENT. THERE WAS NO OTHER DAMAGE TO THE PRODUCT. THE CUSTOMER WAS NOT AWARE OF THE EXACT PROBLEM UNTIL AFTER BYPASS WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18299987 ↗
• MalfunctionMay 24, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A 20012 DLP AORTIC ROOT CANNULA, THE CUSTOMER REPORTED THAT UPON INSERTION OF THE CANNULA, THE SURGEON COULD NOT REMOVE THE STYLET, IT WAS STUCK. THE ENTIRE CANNULA WAS REMOVED AND REPLACED WITH SAME MEDTRONIC CANNULA TO COMPLETE THE PROCEDURE WITH NO ISSUE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16991504 ↗
• MalfunctionSep 13, 2022Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP AORTIC ROOT CANNULA WITH VENT LINE, IT WAS REPORTED THAT THE INTRODUCER WAS JAMMED AND IT WAS DIFFICULT FOR THE SURGEON TO REMOVE IT. USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15409463 ↗
• MalfunctionMar 30, 2022Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A 20012 DLP AORTIC ROOT CANNULA, THE CUSTOMER REPORTED THAT DURING ARTIFICIAL BLOOD CIRCULATION, THE TIP OF THE CANNULA BENT OVER AND THE LIQUID DID NOT FLOW. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13948265 ↗
• MalfunctionJan 6, 2022Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE USE OF A DLP AORTIC ROOT CANNULA WITH VENT LINE, THE CUSTOMER REPORTED THAT THEY INSERTED THE DEVICE INTO THE AORTA AS PER THE NORMAL PROCEDURE. HOWEVER, WHEN THEY TRIED TO REMOVE THE NEEDLE STYLET FROM THE DEVICE, IT WOULDN¿T COME OUT. THE STYLET COULD BE WITHDRAWN ABOUT 80% OF THE WAY OUT, THE CUSTOMER OBSERVED THAT IT WAS STUCK. THE CUSTOMER REMOVED THE ENTIRE DEVICE AND REPLACED IT TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13175474 ↗
• MalfunctionNov 26, 2021Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP AORTIC ROOT CANNULA (WITH VENT LINE), THE CUSTOMER REPORTED AFTER INSERTING THE CANNULA INTO THE AORTA, THE INTRODUCER GOT STUCK WHILE ATTEMPTING TO REMOVE AND WAS UNABLE TO BE REMOVED FROM 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 12877091 ↗
• MalfunctionAug 30, 2018Difficult to Remove; Difficult to Remove

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP AORTIC ROOT CANNULA WITH VENT LINE DURING CARDIOPLEGIA, THE NEEDLE IN THE CANNULA WAS MORE DIFFICULT TO REMOVE. THE DEVICE WAS REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7831998 ↗