DLP® 69328 (UDI 20613994879206)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20613994879206), received between May 24, 2023 and Nov 3, 2025 — classified as 1 death, 3 malfunctions.

The most frequently reported specific device problem is “Crack” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP SINGLE STAGE VENOUS CANNULA WITH A RIGHT ANGLE METAL TIP, IT WAS REPORTED THAT A BREAKAGE ON THE CANNULA WAS DETECTED BY THE SURGEON. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. IT WAS UNKNOWN IF THERE WERE ANY ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23448793 ↗
• MalfunctionMay 9, 2024Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT ANGLE METAL TIP, IT WAS REPORTED THAT THE DEVICE MALFUNCTIONED. THE CUSTOMER STATED THAT THE DEVICE WAS CRACKED/BROKEN. THE PACKAGING WAS FINE, ONLY THIS DEVICE WAS DEFECTIVE. THE PROCEDURE WAS A TRIPLE VALVE REPAIR REPLACEMENT AND WHEN THEY WERE GOING OFF PUMP, THE CUSTOMER OBSERVED A BREAKAGE IN THE WIRE WOUNDING ON THE CANNULA. THE DAMAGE WAS NOT IN THE LOCATION OF THE SUTURES. THE HEMOSTASIS CAP WAS USED WHEN THE INTRODUCER WAS INSERTED INTO THE CANNULA BODY CONNECTOR. 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 19276168 ↗
• MalfunctionOct 12, 2023Crack; Material Puncture/Hole; Crack; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT ANGLE METAL TIP, THE CUSTOMER REPORTED THAT THERE WAS A CRACK. IT WAS ASKED AND WILL NOT BE MADE AVAILABLE DUE TO LEGAL/CONFIDENTIAL REASONS IF THE DEVICE WAS REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17919109 ↗
• DeathMay 24, 2023Fluid/Blood Leak; Material Puncture/Hole; Air/Gas in Device; Fluid/Blood Leak; Material Puncture/Hole; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT ANGLE METAL TIP, THE CUSTOMER REPORTED A MASSIVE AIR ENTRY INTO THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CIRCUIT, ESPECIALLY AT THE OXYGENATOR MEMBRANE. PERSISTENCE OF AIR OCCURRED, DESPITE DE-BUBBLING BY THE PUMP OPERATOR. THE CUSTOMER CLAMPED ECMO, AND DE-BULKED SINGLE PERCUTANEOUS SELDINGER TECHNIQUE (PST) FROM THE CENTRAL OBSERVATION OF A SECTION OF THE VENOUS CANNULA WHEN THE INTRODUCER WAS PLACED. MASSIVE HEMORRHAGE OCCURRED DESPITE CLOSING THE CLAMPING WHICH LED TO THE IMPOSSIBILITY OF CHANGING THE CANNULA IMMEDIATELY AND RESULTED IN THE DEATH OF THE PATIENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE "PST" IS REFERRING TO A CUT OF THE VENOUS CANNULA, PERCUTANEOUS SELDINGER TECHNIQUE. THE CANNULA WAS PLACED IN THE SUPERIOR VENA CAVA. THE CUSTOMER STATED THAT THE AIR ENTERED THROUGH THE CUT IN THE CANNULA. THE CANNULA WAS USED DURING TWO HOURS OF EXTRA-CORPOREAL CIRCULATION (ECC), THEN IT WAS NECESSARY TO CONNECT AN ECMO SYSTEM TO THIS CANNULA, THE CUSTOMER STATED THAT THIS WAS WHEN THE AIR APPEARED. THE CUSTOMER STATED THAT THE CUT IN THE CANNULA CAUSED THE MASSIVE HE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16990361 ↗