DLP™ 77008Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20763000091105), received between Jan 17, 2023 and Aug 18, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 reports).

2 FDA recall records name this device's identifier, 2 still open.

1 other recall 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 12, 2024Open, Classified

   Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.

   Z-0984-2025 · Root cause: Packaging · FDA record ↗

2. Mar 19, 2024Open, Classified

   Potential for unsealed sterile packing.

   Z-1793-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50300038 ↗
• MalfunctionOct 8, 2024Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, IT WAS REPORTED THAT THE CANNULA WAS FOUND TO BE BROKEN DURING PLACEMENT. THE DEVICE WAS DESCRIBED AS RUPTURED. 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 20395496 ↗
• MalfunctionSep 25, 2024Device Markings/Labelling Problem; Misassembled During Installation; Device Markings/Labelling Problem; Misassembled During Installation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, IT WAS REPORTED THAT THE DEVICE HAD A 16FR CANNULA INSIDE THE PACK INSTEAD OF A 8FR. SEE ATTACHED PHOTOS. THE DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20299896 ↗
• MalfunctionApr 9, 2024Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, IT WAS REPORTED THAT THERE WAS A CRACK IN THE BODY OF THE DEVICE UPON SECURING THE CANNULA INTO THE AORTA WITH A 5-0 PROLENE AORTIC SUTURE. THE CRACK WAS LOCATED NEAR THE 1CM MARKER FROM THE DISTAL TIP. THE CUSTOMER STATED THAT IT WAS A SIGNIFICANT CRACK IN THE CANNULA BODY. THE DAMAGE WAS IN THE LOCATION OF THE SUTURES. 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 19069363 ↗
• MalfunctionDec 27, 2023Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, IT WAS REPORTED THAT THE CANNULA HAD A CRACK IN THE TIP. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18396707 ↗
• MalfunctionDec 19, 2023Increase in Pressure; Material Deformation; Increase in Pressure; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, THE CUSTOMER REPORTED A POTENTIAL COMPROMISE OF THE MATERIAL IN THE CANNULA WALL APPROX. 5MM FROM THE TIP. THE CUSTOMER STATED THAT THE CANULA HAD BEEN INSERTED AND SECURED, AND CPB INITIATED AND UNEXPECTEDLY HIGH LINE PRESSURE WAS OBSERVED IN THE FIRST 2 MINUTES OF THE BYPASS. THE CUSTOMER ADJUSTED THE CANNULA POSITION AND NOTICED INCONSISTENCY IN THE CANNULA WALL MATERIAL. THE CROSS CLAMP WAS NOT ON AND THE PATIENT WAS STILL BEING VENTILATED AT THE TIME OF THE REPORTED EVENT. THE CUSTOMER STATED THAT THERE WAS NO COMPROMISE TO THE PATIENT. THE CUSTOMER DID NOT NOTICE ANY DAMAGE TO THE DEVICE PACKAGING OR ANY DAMAGE DURING THE INSERTION OF THE CANNULA. THE DEVICE WAS REPLACED AND THE AORTA RE-CANNULATED WITH A NEW CANNULA TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18354860 ↗
• MalfunctionAug 30, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, THE CUSTOMER REPORTED THAT CANNULA BROKE INSIDE THE PATIENT'S BODY. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17649830 ↗
• MalfunctionJul 4, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA, IT WAS REPORTED THAT THE TAIL END OF THE CANNULA LEAKED AND HAD CRACKS. 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 17253697 ↗
• MalfunctionJan 17, 2023Crack; Increase in Pressure; Crack; Increase in Pressure

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE WHEN INITIATING CARDIOPULMONARY BYPASS, THIS DLP PEDIATRIC ONE-PIECE ARTERIAL CANNULA WAS REPORTED TO HAVE FEEDBACK PRESSURES THAT WERE TOO HIGH AND THE CUSTOMER OBSERVED THAT THE AORTIC CANNULA WAS PARTIALLY SEVERED AT ITS LOWER PART BY THE THREAD OF SUTURE USED TO HOLD IT TO THE SKIN. IT WAS STATED THAT THIS REQUIRED AN EMERGENCY AORTIC CANNULA CHANGE DURING THE SURGERY. THERE WAS NO PATIENT IMPACT REPORTED WITH THIS EVENT. IT WAS STATED THAT THE PATIENT WAS TREATED FOR VENTRICULAR SEPTAL CLOSURE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE TO THE PACKAGING (OUTER BOX, INNER PACKAGING OR STERILE BARRIER). THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE.

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

  MAUDE report 16182747 ↗

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