DLP™ 77208 (UDI 20763000091037)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20763000091037), received between Sep 6, 2022 and Dec 18, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Crack” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K024069); they may or may not involve this specific model.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Delivered as Unsterile Product; Material Deformation; Delivered as Unsterile Product; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, IT WAS REPORTED THAT WHEN THE CUSTOMER PICKED THE CANNULA AND THEY NOTED THAT THE TIP WAS SQUISHED WITHIN THE SEALING EDGE OF THE PACKAGE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA TIP WAS COMPRESSED IN THE SEALING EDGE. IT LOOKED LIKE THE STERILE SEAL WAS INTACT. IT IS UNKNOWN IF THE TIP WAS OBSTRUCTED BECAUSE IT WAS STILL IN THE PACKAGE. IT IS UNKNOWN IF THE TIP DETACHED FROM THE CANNULA BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840596 ↗
• MalfunctionJul 14, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE GUIDE WAS PLACED IN THE DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, BUT THE END DID NOT PROTRUDE FROM THE CANNULA DESPITE SEVERAL ATTEMPTS PRIOR TO USE. THE USE OF THE DEVICE WAS UNSPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22492224 ↗
• MalfunctionApr 10, 2024Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, IT WAS REPORTED THAT THE CANNULA SHEATH WAS BROKEN. THE REINFORCING WIRE WAS VISIBLE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION FROM THE CUSTOMER STATING THAT THERE WAS NO LEAK AT THE CANNULA BODY. THE CUSTOMER STATED THAT THE ISSUE HAPPENED WHEN THE CANNULA WAS DRAWN OUT. INFORMATION ON WHETHER THE CANNULA WAS HEATED OR COOLED PRIOR TO USE WAS NOT AVAILABLE, BUT THE CUSTOMER STATED THAT THIS IS NOT NORMALLY THEIR PRACTICE. THE CUSTOMER STATED THAT THE CAUSE OF THE DAMAGE WAS UNKNOWN. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS DAMAGED IN THE FRONT PART OF THE CANNULA BODY. THE CANNULA BODY WAS BROKEN WHEN THE CANNULA WAS TAKEN OUT OF THE AORTA. BEFORE INTRODUCING IT, THERE WAS NO DAMAGE SEEN. THE PERFORMANCE AND FLOW DURING THE PROCEDURE WERE AS EXPECTED. THE CUSTOMER COULD NOT CONFIRM IF THE CANNULA WAS SUTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19077776 ↗
• MalfunctionAug 4, 2023Increase in Pressure; Material Puncture/Hole; Increase in Pressure; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, IT WAS REPORTED THAT A 5 DAY OLD PATIENT WAS ADMITTED FOR TRANSPOSITION OF THE GREAT VESSELS AND DURING THE BYPASS PROCEDURE, THE CANNULA PRESSURE WAS VERY HIGH THOUGH THE MAXIMUM FLOW HAD NOT BEEN REACHED. THE DEVICE WAS REMOVED BY THE PHYSCIAN DURING THE OPERATION AND NOTICED A SHEAR CAUSED BY THE PURSE STRING SUTURE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17457545 ↗
• MalfunctionJul 27, 2023Fracture; Mechanical Problem; Fracture; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, IT WAS REPORTED THAT THE CANNULA GUIDE WAS STICKING OUT EXCESSIVELY DURING CANNULATION. IT WAS STATED THAT THE DEFECT COULD NOT BE NOTED VISUALLY. THE CUSTOMER STATED THAT AT THE BEGINNING OF CARDIOPULMONARY BYPASS, THERE WAS HIGH RESISTANCE. THE POSITION OF THE CANNULA WAS CHANGED, BUT IT DID NOT LEAD TO RESULTS. WHEN THE PHYSICIAN TRIED TO CHANGE THE POSITION OF THE CANNULA, THEY NOTED THAT THERE WAS A PROTRUDING SPRING AND A FRACTURE OF THE CANNULA WAS FOUND. THE CARDIOPULMONARY BYPASS WAS DISCONTINUED TO STOP THE ARTIFICIAL CIRCULATION AND REPLACE THE DAMAGED CANNULA. THERE WERE NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO VISIBLE DAMAGE TO THE PACKAGING. NO OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE DAMAGED. THERE WAS NO LEAK FROM THE CANNULA, OR FROM THE CONNECTION BETWEEN A CANNULA AND A CONNECTOR. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THE NURSE BROUGHT THE CANNULA FROM A SPECIAL STORAGE ROOM NEXT TO THE OPERATING ROOM, THERE WERE NO TEMPERATURE STORAGE VIOLATIONS. THE CANNULA WAS OPENED BEFOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17410038 ↗
• MalfunctionMay 22, 2023Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF 8 77208 DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULAE, IT WAS NOTED THAT THERE WAS A CLEAR VISIBLE CUT IN THE BODY OF THE CANNULAE. THE PEEL POUCH HAD NOT BEEN OPENED. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16973063 ↗
• InjurySep 6, 2022Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, IT WAS REPORTED THAT DURING THE CANNULA EXTRACTION FROM THE PATIENT IN THE FINAL STAGES OF THE OPEN HEART SURGERY, THE CANNULA CAME OUT WITH A SPLIT ON THE BODY OF THE CANNULA. THE CANNULA HAD BEEN USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

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

  MAUDE report 15360129 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K024069. One submission often covers many models, so check the product and lot details in each record.

• Z-2738-2026 · May 25, 2026 · Open, Classified
  Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula
• Z-0984-2025 · Dec 12, 2024 · Open, Classified
  DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)