DLP® 20014Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 20613994495543), received between Jan 13, 2017 and Aug 17, 2026 — classified as 1 injury, 53 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (45 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Material Deformation

  Medtronic received information that prior to use of a DLP Aortic Root Cannula with a Vent Line, it was reported that the device was deformed, the sewing flange was bent/ curved downward towards the needle, and they should be flat. There was no damage to the packaging, and no other devices in the same box/shipping container were damaged. See attached photos. The device was not used. There was no patient involvement, so no adverse effect occurred.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50277083 ↗
• MalfunctionJan 8, 2026Delivered as Unsterile Product; Component Missing

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP AORTIC ROOT CANNULA WITH VENT LINE, IT WAS REPORTED THAT THE CANNULA WAS OBSERVED WITHOUT A PROTECTIVE COVER ON THE INTRODUCER NEEDLE AND SO IT APPEARED TO HAVE PIERCED THROUGH THE PACKAGING. 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 24001410 ↗
• MalfunctionDec 18, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT PRIOR TO USE THE DLP AORTIC ROOT LINE CANNULA WITH VENT LINE HAD AN ISSUE WITH DAMAGED PRODUCT PACKAGING. THERE WAS NO REPLACEMENT EQUIPMENT TO COMPLETE THE PROCEDURE AFTER OBSERVING THE ISSUE. THERE WERE NO PATIENTS INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840539 ↗
• MalfunctionAug 21, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING USE OF A DLP AORTIC ROOT CANNULA WITH VENT LINE, THE TEAM HAD AN ISSUE WHEREBY THE STYLET WOULD NOT COME OUT OF THE CANNULA BODY AND WAS STUCK. THE TEAM HAD DIFFICULTY REMOVING THE STYLET WHICH WAS NOT AN ISSUE WHEN THEY WERE SETTING UP AS THEY DO NOT REMOVE THE STYLET FROM THE CANNULA IN SET UP. THIS ISSUE WAS NOTICED DURING THE CASE WHEN THEY WERE CANNULATING THE AORTA AND TRIED TO REMOVE THE STYLET FROM THE CANNULA BODY, TO FIND THE STYLET WAS STUCK AND WOULD NOT COME OUT. TO RESOLVE THIS ISSUE THE TEAM HAD TO REMOVE THE AORTIC ROOT CANNULA AND PUT A NEW ONE IN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860164 ↗
• MalfunctionAug 20, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT DURING A CORONARY ARTERY BYPASS GRAFT PROCEDURE, IT WAS REPORTED THAT TWO DLP AORTIC ROOT CANNULAE WITH VENT LINES FAILED. THE CANNULAE REMAINED NON-FUNCTIONAL AFTER ACTIVATION. THE FIRST CANNULA, SOURCED FROM A THIRD-PARTY SURGICAL PACK, WAS INSERTED INTO THE AORTA, THE STYLET WAS REMOVED, AND THE PUMP SUCTION LINE WAS ATTACHED TO THE VENT LINE, BUT THE VENT DID NOT FUNCTION. VISUAL INSPECTION CONFIRMED NO KINKS OR OBSTRUCTIONS IN THE TUBING, AND INDEPENDENT TESTING VERIFIED THE PUMP SUCTION LINE WAS WORKING. AFTER REATTACHING THE LINE, THE VENT REMAINED NON-FUNCTIONAL, LEADING TO REMOVAL AND REPLACEMENT WITH A SINGLE-PACKED DLP AORTIC ROOT CANNULA, WHICH ALSO FAILED IN THE SAME MANNER. BOTH CANNULAE WERE REMOVED, AND AN ALTERNATIVE AORTIC ROOT CANNULA WAS USED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT A FLOW ISSUE WAS OBSERVED. IT APPEARED THAT THERE WAS NO BLOOD FLOW THROUGH THE CANNULAE. THE BYPASS TIME WAS PROLONGED BY 3 TO 5 MINUTES AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22849183 ↗
• MalfunctionJul 8, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE DLP AORTIC ROOT CANNULA WITH A VENT LINE, THE SURGEON PLACED THE AORTIC ROOT NEEDLE INTO THE ASCENDING AORTA WITHOUT ANY DIFFICULTY. THE CARDIOPLEGIA LINE WAS CONNECTED TO THE CARDIOPLEGIA PORT OF THE ROOT NEEDLE AND THE 1/4¿ VENT LINE WAS CONNECTED TO THE VENT PORT ON THE ROOT NEEDLE. THE SURGEON OPENED THE ROOT VENT LINE CLAMP TO FILL THE VENT AND THERE WAS NO BLOOD FLOW COMING BACK THROUGH THE VENT LINE. THE DURATION OF CANNULATION WAS 5 MINUTES. THE ISSUE DID NOT WORSEN OVER TIME. UPON FURTHER INSPECTION AFTER IT WAS REMOVED FROM THE OR (OPERATING ROOM), THE PERFUSIONIST TRIED TO INJECT FLUID THROUGH THE VENT LINE AND THERE WAS NO FLUID COMING OUT OF THE VENT PORT. IT WAS SUSPECTED THAT THE VENT PORT WAS OCCLUDED WITH FOREIGN MATERIAL. THE CANNULA BODY AND TIP SHOWED NO DAMAGE, AND ANTICOAGULANT WAS USED. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22434553 ↗
• MalfunctionMay 26, 2025Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT THE CAP OF THE DLP AORTIC ROOT CANNULA WITH A VENT LINE WAS STUCK TO THE SCREW PRIOR TO USE. UPON OPENING, THE SCREW WAS BROKEN. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084302 ↗
• MalfunctionApr 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP AORTIC ROOT CANNULA WITH A VENT LINE, IT WAS REPORTED THAT A BLOOD LEAKAGE OCCURRED FROM THE CONNECTION TO THE CIRCUIT. THE CANNULA WAS CHECKED, HOWEVER, THERE WAS NO PARTICULAR DEFECTS SUCH AS CRACKING OR DEFORMATION OBSERVED. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21880014 ↗
• MalfunctionApr 22, 2025Contamination; Mechanical Problem; Material Deformation; Contamination; Mechanical Problem; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP AORTIC ROOT CANNULA WITH A VENT LINE, IT WAS REPORTED THAT AT THE MOMENT THE NEEDLE WAS INSERTED INTO THE VEIN, THE LUER LOCK THAT WAS HOLDING THE NEEDLE IN PLACE WAS DIFFICULT TO REMOVE. WHEN THEY USED FORCE TO REMOVE IT, A WHITE SPONGE-LIKE PART REMAINED IN THE LUER LOCK PART. IT APPEARED THAT THE LUER PART HAD ALSO BEEN DEFORMED. AFTER THE PUNCTURE, IT APPEARED THAT NO BLOOD WAS TOUCHED ANYWHERE OTHER THAN THE NEEDLE AND THERE WAS NO BLOOD STAINING ANYWHERE ELSE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THAT THE SCREW PART AT THE TOP OF THE CANNULA WAS HARD AND DID NOT COME OFF. IT COULD NOT BE CHECK WITH THE PHYSICIAN IN CHARGE, SO THE CUSTOMER IS UNSURE. AS FOR THE DEFORMATION, IT MAY HAVE BEEN DEFORMED BECAUSE IT WAS REMOVED WITH FORCE BUT IT WAS NOT KNOWN WHETHER IT WAS ACTUALLY DEFORMED. THE WHITE SPONGE-LIKE PART IS REFERRING TO THE MIDDLE OF THE AXIS, THERE IS A WHITE SUBSTANCE OF APPROXIMATELY 2MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21879824 ↗
• MalfunctionFeb 25, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP AORTIC ROOT CANNULAE WITH A VENT LINE, THE CUSTOMER REPORTED THAT IT WAS IMPOSSIBLE TO REMOVE THE INTRODUCER NEEDLE FROM THE CANNULAE. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457343 ↗
• MalfunctionFeb 25, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP AORTIC ROOT CANNULAE WITH A VENT LINE, THE CUSTOMER REPORTED THAT IT WAS IMPOSSIBLE TO REMOVE THE INTRODUCER NEEDLE FROM THE CANNULAE.  THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457312 ↗
• MalfunctionFeb 25, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP AORTIC ROOT CANNULAE WITH A VENT LINE, THE CUSTOMER REPORTED THAT IT WAS IMPOSSIBLE TO REMOVE THE INTRODUCER NEEDLE FROM THE CANNULAE. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457258 ↗
• MalfunctionFeb 25, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP AORTIC ROOT CANNULAE WITH A VENT LINE, THE CUSTOMER REPORTED THAT IT WAS IMPOSSIBLE TO REMOVE THE INTRODUCER NEEDLE FROM THE CANNULAE. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457251 ↗
• MalfunctionFeb 25, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP AORTIC ROOT CANNULAE WITH A VENT LINE, THE CUSTOMER REPORTED THAT IT WAS IMPOSSIBLE TO REMOVE THE INTRODUCER NEEDLE FROM THE CANNULAE. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457221 ↗
• MalfunctionFeb 25, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP AORTIC ROOT CANNULAE WITH A VENT LINE, THE CUSTOMER REPORTED THAT IT WAS IMPOSSIBLE TO REMOVE THE INTRODUCER NEEDLE FROM THE CANNULAE. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457203 ↗
• MalfunctionFeb 25, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP AORTIC ROOT CANNULAE WITH A VENT LINE, THE CUSTOMER REPORTED THAT IT WAS IMPOSSIBLE TO REMOVE THE INTRODUCER NEEDLE FROM THE CANNULAE. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457143 ↗
• MalfunctionFeb 25, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP AORTIC ROOT CANNULAE WITH A VENT LINE, THE CUSTOMER REPORTED THAT IT WAS IMPOSSIBLE TO REMOVE THE INTRODUCER NEEDLE FROM THE CANNULAE. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457123 ↗
• MalfunctionFeb 25, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP AORTIC ROOT CANNULAE WITH A VENT LINE, THE CUSTOMER REPORTED THAT IT WAS IMPOSSIBLE TO REMOVE THE INTRODUCER NEEDLE FROM THE CANNULAE. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457094 ↗
• MalfunctionFeb 25, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP AORTIC ROOT CANNULAE WITH A VENT LINE, THE CUSTOMER REPORTED THAT IT WAS IMPOSSIBLE TO REMOVE THE INTRODUCER NEEDLE FROM THE CANNULAE. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457072 ↗
• MalfunctionFeb 25, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP AORTIC ROOT CANNULAE WITH A VENT LINE, THE CUSTOMER REPORTED THAT IT WAS IMPOSSIBLE TO REMOVE THE INTRODUCER NEEDLE FROM THE CANNULAE.  THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457057 ↗
• MalfunctionFeb 25, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP AORTIC ROOT CANNULAE WITH A VENT LINE, THE CUSTOMER REPORTED THAT IT WAS IMPOSSIBLE TO REMOVE THE INTRODUCER NEEDLE FROM THE CANNULAE.  THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457026 ↗
• MalfunctionFeb 25, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP AORTIC ROOT CANNULAE WITH A VENT LINE, THE CUSTOMER REPORTED THAT IT WAS IMPOSSIBLE TO REMOVE THE INTRODUCER NEEDLE FROM THE CANNULAE. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457008 ↗
• MalfunctionFeb 25, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP AORTIC ROOT CANNULAE WITH A VENT LINE, THE CUSTOMER REPORTED THAT IT WAS IMPOSSIBLE TO REMOVE THE INTRODUCER NEEDLE FROM THE CANNULAE. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21456988 ↗
• MalfunctionFeb 25, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP AORTIC ROOT CANNULAE WITH A VENT LINE, THE CUSTOMER REPORTED THAT IT WAS IMPOSSIBLE TO REMOVE THE INTRODUCER NEEDLE FROM THE CANNULAE. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21456968 ↗
• MalfunctionFeb 25, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP AORTIC ROOT CANNULAE WITH A VENT LINE, THE CUSTOMER REPORTED THAT IT WAS IMPOSSIBLE TO REMOVE THE INTRODUCER NEEDLE FROM THE CANNULAE. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21456935 ↗