DLP® 30012Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 20613994576037), received between May 10, 2024 and Sep 28, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (15 reports).

1 other recall cover devices cleared under the same FDA submission (K131269, K821149); 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Material Separation

  Medtronic received information that during use of a DLP coronary artery ostial cannula, it was reported that the connector was not fully secured to the metal tubing. During use, the connector became loose and detached from the metal tubing. The use of the device was unspecified. There was no reported adverse patient effect associated with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50912804 ↗
• MalfunctionJan 6, 2026Mechanical Problem; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP CORONARY ARTERY OSTIAL CANNULA, IT WAS REPORTED THAT THE CANNULA WAS BLOCKED AND CARDIOPLEGIA INFUSION COULD NOT BE PERFORMED. THE DOCTOR DISCONTINUED USE OF THE PRODUCT AND REPLACED IT WITH A NEW ONE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23971803 ↗
• MalfunctionSep 2, 2025Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  IT WAS REPORTED THAT A DLP CORONARY ARTERY OSTIAL CANNULA WAS ALLEGED TO HAVE A PRODUCT ISSUE DURING USE, THE PERFUSION CANNULA COULD NOT BE PERFUSED AND A BLOCKAGE WAS FOUND IN THE CANNULA WHEN INJECTING WITH A NEEDLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22932224 ↗
• MalfunctionJul 15, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE DLP CORONARY ARTERY OSTIAL CANNULA, THE CANNULA WAS HANDED TO THE OPERATING TABLE AND, WHEN FLUSHED WITH 4:1 BLOOD CARDIOPLEGIA SOLUTION, EXHIBITED NO FLOW. THE CLINICIAN SUGGESTED THE CANNULA WAS BLOCKED. THERE WAS NO DAMAGE TO THE PRODUCT OR PACKAGING. A REPLACEMENT CANNULA OF THE SAME TYPE FROM A DIFFERENT LOT WAS OPENED, RESULTING IN A VERY SHORT PROCEDURAL DELAY OF TWO MINUTES, AND CARDIOPLEGIA WAS DELIVERED SUCCESSFULLY. AFTER THE REPLACEMENT, ATTEMPTS TO FLUSH SALINE THROUGH THE INITIAL CANNULA WERE UNSUCCESSFUL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505281 ↗
• MalfunctionJun 11, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT DURING USE OF THE DLP CORONARY ARTERY OSTIAL CANNULA, AN OBSTRUCTION WAS ENCOUNTERED AND PERFUSION FLOW WAS NOT SMOOTH. TO ENSURE SMOOTH SURGICAL PROGRESS, THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. IT WAS UNKNOWN WHETHER THERE WAS ANY IMPACT TO THE PATIENT AS A RESULT OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22185714 ↗
• MalfunctionFeb 12, 2025Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT BEFORE INSERTING A DLP CORONARY ARTERY OSTIAL CANNULA INTO THE PATIENT, IT WAS REPORTED THAT THE DEVICE HAD A BLOCKAGE WHEN INJECTING INTO THE CORONARY OSTIA. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO PACKAGING DAMAGED (OUTER BOX, INNER PACKAGE, OR STERILE BARRIER). OTHER DEVICES IN THE SAME SHIPPING BOX/CONTAINER WERE NOT DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21362654 ↗
• MalfunctionFeb 6, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A DLP CORONARY ARTERY OSTIAL CANNULA, THE DEVICE WAS FOUND TO BE BLOCKED AND COULD NOT BE USED CLINICALLY. THIS BLOCKAGE LED TO A MINOR DELAY IN ADMINISTERING CARDIOPLEGIA AS THE TEAM SWITCHED TO A NEW CANNULA. ATTEMPTS TO UNBLOCK THE CANNULA USING A SYRINGE AND HIGH PRESSURE WERE UNSUCCESSFUL. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21320297 ↗
• MalfunctionJan 8, 2025Fluid/Blood Leak; Obstruction of Flow; Fluid/Blood Leak; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP CORONARY ARTERY OSTIAL CANNULA, THE CUSTOMER REPORTED A LEAK. THE LEAK WAS BETWEEN THE METAL HANDLE AND THE BLUE PLASTIC DISPERSION TIP AT THE DISTAL END OF THE DEVICE. FLUID WAS NOTED TO BE COMING OUT AROUND THE JUNCTION OF THE TIP CONNECTION AND NOT JUST OUT OF THE END HOLES AS IT SHOULD HAVE BEEN. PATIENT BLOOD LOSS DID NOT OCCUR AS A RESULT OF THIS LEAK. AN UNPLANNED BLOOD TRANSFUSION WAS NOT REQUIRED. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS AN ABNORMAL DISTRIBUTION OF THE SPG SOLUTION. THERE WAS INTERNAL OBSTRUCTION POSSIBLE. THE OSTIAL CARDIOPLEGIA WAS HANDHELD. THE ORIGINAL INTENDED PROCEDURE WAS FOR AN AORTIC ROOT REPLACEMENT WITH 27MM KONNECT GRAFT, CORONARY ARTERY BYPASS GRAFTING AND SAPHENOUS VEIN GRAFT TO DISTAL RIGHT CORONARY ARTERY (RCA).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106019 ↗
• MalfunctionOct 3, 2024Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP CORONARY ARTERY OSTIAL CANNULA, IT WAS REPORTED THAT DURING BLOOD CARDIOPLEGIA, THE CUSTOMER WAS UNABLE TO GET FLOW THROUGH THE DEVICE, CUSTOMER ATTEMPTED TO FLUSH THE DEVICE WITH SALINE BUT THERE WAS STILL NO FLOW. AS THIS WAS DURING CARDIOPULMONARY BYPASS THE PATIENT WAS FULLY HEPARINISED AND THE CANNULA HAD JUST BEEN CONNECTED SO BLOOD HAD NOT BEEN SAT STAGNANT IN THE CANNULA. 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 20360979 ↗
• MalfunctionSep 19, 2024Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, DLP CORONARY ARTERY OSTIAL CANNULAE WERE USED FOR AORTIC VALVE REPLACEMENT (AVR) AND CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE. THE CANNULAE WERE BLOCKED AND FAILED TO DELIVER CARDIOPLEGIA. A NEW CANNULA WAS THEN USED TO DELIVER CARDIOPLEGIA. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20255724 ↗
• MalfunctionSep 19, 2024Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, DLP CORONARY ARTERY OSTIAL CANNULAE WERE USED FOR AORTIC VALVE REPLACEMENT (AVR) AND CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE. THE CANNULAE WERE BLOCKED AND FAILED TO DELIVER CARDIOPLEGIA. A NEW CANNULA WAS THEN USED TO DELIVER CARDIOPLEGIA. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20255617 ↗
• MalfunctionSep 19, 2024Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, DLP CORONARY ARTERY OSTIAL CANNULAE WERE USED FOR AORTIC VALVE REPLACEMENT (AVR) AND CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE. THE CANNULAE WERE BLOCKED AND FAILED TO DELIVER CARDIOPLEGIA. A NEW CANNULA WAS THEN USED TO DELIVER CARDIOPLEGIA. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20255597 ↗
• MalfunctionSep 12, 2024Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP CORONARY ARTERY OSTIAL CANNULA, IT WAS REPORTED THAT DURING AN AVR AND CORONARY ARTERY BYPASS GRAFTING (CABG) PROCEDURE, THE FIRST CANNULA WAS BLOCKED AND FAILED TO DELIVER CARDIOPLEGIA. THE FIRST DEVICE WAS REPLACED WITH ANOTHER CANNULA WHICH WAS ALSO FOUND TO BE DEFECTIVE. THE SECOND DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE WITH A SMALLER CANNULA (30010) THAT WAS USED TO DELIVER THE CARDIOPLEGIA. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. ADDITIONAL DLP CORONARY ARTERY OSTIAL CANNULAE WERE RETURNED FOR ANALYSIS. DURING ANALYSIS ONE OF THE RETURNED CANNULAE WAS BLOCKED AND HAD NO FLOW. THE REMAINING RETURNED CANNULAE PERFORMED AS A EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20199995 ↗
• MalfunctionSep 3, 2024Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP CORONARY ARTERY OSTIAL CANNULA, IT WAS REPORTED THAT DURING AN AVR AND CORONARY ARTERY BYPASS GRAFTING (CABG) PROCEDURE, THE FIRST CANNULA WAS BLOCKED AND FAILED TO DELIVER CARDIOPLEGIA. THE FIRST DEVICE WAS REPLACED WITH ANOTHER CANNULA WHICH WAS ALSO FOUND TO BE DEFECTIVE. THE SECOND DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE WITH A SMALLER CANNULA THAT WAS USED TO DELIVER THE CARDIOPLEGIA. ADDITIONAL DLP CORONARY ARTERY OSTIAL CANNULAE WERE RETURNED FOR ANALYSIS. DURING ANALYSIS ONE OF THE RETURNED CANNULAE WAS BLOCKED AND HAD NO FLOW. THE REMAINING RETURNED CANNULAE PERFORMED AS A EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20125673 ↗
• MalfunctionMay 10, 2024Obstruction of Flow; Material Deformation; Obstruction of Flow; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF DLP CORONARY ARTERY OSTIAL CANNULAE, IT WAS REPORTED THAT THE CUSTOMER OPENED TWO OF THESE DEVICES DURING THE PROCEDURE AND BOTH SEEMED TO HAVE AN OBSTRUCTION THAT PREVENTED BLOOD FROM FLOWING THROUGH. THERE WAS NO DAMAGE TO THE PACKAGING. THE DEVICES WERE 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 19284048 ↗
• MalfunctionMay 10, 2024Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF DLP CORONARY ARTERY OSTIAL CANNULAE, IT WAS REPORTED THAT THE CUSTOMER OPENED TWO OF THESE DEVICES DURING THE PROCEDURE AND BOTH SEEMED TO HAVE AN OBSTRUCTION THAT PREVENTED BLOOD FROM FLOWING THROUGH. THERE WAS NO DAMAGE TO THE PACKAGING. THE DEVICES WERE 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 19284034 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131269, K821149. One submission often covers many models, so check the product and lot details in each record.

• Z-1795-2024 · Mar 19, 2024 · Open, Classified
  Medtronic DLP Coronary Ostial Cannulae, Model Number 30050