DLP® 30212Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 20613994575955), received between Aug 15, 2023 and Mar 4, 2025 — classified as 54 malfunctions.

The most frequently reported specific device problem is “Material Separation” (54 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. 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.

• MalfunctionMar 4, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE, OF THE DLP HIGH FLOW CORONARY ARTERY OSTIAL CANNULAE, IT WAS REPORTED THAT THE TIPS ROTATED. THE CUSTOMER ALSO NOTICED THAT THE TIP OF ONE DLP HIGH FLOW CORONARY ARTERY OSTIAL CANNULA HAD DETACHED BEFORE IT WAS USED. THE CANNULAE WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIPS THAT ROTATED DURING USE DID NOT DETACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21512829 ↗
• MalfunctionMar 4, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE, OF THE DLP HIGH FLOW CORONARY ARTERY OSTIAL CANNULAE, IT WAS REPORTED THAT THE TIPS ROTATED. THE CUSTOMER ALSO NOTICED THAT THE TIP OF ONE DLP HIGH FLOW CORONARY ARTERY OSTIAL CANNULA HAD DETACHED BEFORE IT WAS USED. THE CANNULAE WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIPS THAT ROTATED DURING USE DID NOT DETACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21512727 ↗
• MalfunctionFeb 18, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP CORONARY OSTIAL PERFUSION CANNULAE, THE CUSTOMER REPORTED THAT THEY HAVE OBSERVED THAT THE TIPS ON ALL THE DEVICES OF VARIOUS LOT NUMBERS WERE ALL ROTATING BY THEMSELVES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIPS WERE NOT OBSTRUCTED. IT WAS NOTICED THAT THE TIPS EASILY DETACHED FROM THE C CANNULAE BODIES. THE CANNULAE WERE NOT HEATED OR COOLED PRIOR TO USE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE TIPS WERE SPINNING WHILE THE CARDIAC SURGEON WAS HOLDING THE CANNULAE AND THEY NOTICED THAT THE TIPS MOVED FREELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21400344 ↗
• MalfunctionFeb 18, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP CORONARY OSTIAL PERFUSION CANNULAE, THE CUSTOMER REPORTED THAT THEY HAVE OBSERVED THAT THE TIPS ON ALL THE DEVICES OF VARIOUS LOT NUMBERS WERE ALL ROTATING BY THEMSELVES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIPS WERE NOT OBSTRUCTED. IT WAS NOTICED THAT THE TIPS EASILY DETACHED FROM THE CANNULAE BODIES. THE CANNULAE WERE NOT HEATED OR COOLED PRIOR TO USE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE TIPS WERE SPINNING WHILE THE CARDIAC SURGEON WAS HOLDING THE CANNULAE AND THEY NOTICED THAT THE TIPS MOVED FREELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21400090 ↗
• MalfunctionFeb 18, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP CORONARY OSTIAL PERFUSION CANNULAE, THE CUSTOMER REPORTED THAT THEY HAVE OBSERVED THAT THE TIPS ON ALL THE DEVICES OF VARIOUS LOT NUMBERS WERE ALL ROTATING BY THEMSELVES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIPS WERE NOT OBSTRUCTED. IT WAS NOTICED THAT THE TIPS EASILY DETACHED FROM THE C CANNULAE BODIES. THE CANNULAE WERE NOT HEATED OR COOLED PRIOR TO USE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE TIPS WERE SPINNING WHILE THE CARDIAC SURGEON WAS HOLDING THE CANNULAE AND THEY NOTICED THAT THE TIPS MOVED FREELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21398584 ↗
• MalfunctionFeb 18, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP CORONARY OSTIAL PERFUSION CANNULAE, THE CUSTOMER REPORTED THAT THEY HAVE OBSERVED THAT THE TIPS ON ALL THE DEVICES OF VARIOUS LOT NUMBERS WERE ALL ROTATING BY THEMSELVES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIPS WERE NOT OBSTRUCTED. IT WAS NOTICED THAT THE TIPS EASILY DETACHED FROM THE C ANNULAE BODIES. THE CANNULAE WERE NOT HEATED OR COOLED PRIOR TO USE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE TIPS WERE SPINNING WHILE THE CARDIAC SURGEON WAS HOLDING THE CANNULAE AND THEY NOTICED THAT THE TIPS MOVED FREELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21398172 ↗
• MalfunctionFeb 18, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP CORONARY OSTIAL PERFUSION CANNULAE, THE CUSTOMER REPORTED THAT THEY HAVE OBSERVED THAT THE TIPS ON ALL THE DEVICES OF VARIOUS LOT NUMBERS WERE ALL ROTATING BY THEMSELVES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIPS WERE NOT OBSTRUCTED. IT WAS NOTICED THAT THE TIPS EASILY DETACHED FROM THE CANNULAE BODIES. THE CANNULAE WERE NOT HEATED OR COOLED PRIOR TO USE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE TIPS WERE SPINNING WHILE THE CARDIAC SURGEON WAS HOLDING THE CANNULAE AND THEY NOTICED THAT THE TIPS MOVED FREELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21397237 ↗
• MalfunctionFeb 18, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP CORONARY OSTIAL PERFUSION CANNULAE, THE CUSTOMER REPORTED THAT THEY HAVE OBSERVED THAT THE TIPS ON ALL THE DEVICES OF VARIOUS LOT NUMBERS WERE ALL ROTATING BY THEMSELVES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIPS WERE NOT OBSTRUCTED. IT WAS NOTICED THAT THE TIPS EASILY DETACHED FROM THE CANNULAE BODIES. THE CANNULAE WERE NOT HEATED OR COOLED PRIOR TO USE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE TIPS WERE SPINNING WHILE THE CARDIAC SURGEON WAS HOLDING THE CANNULAE AND THEY NOTICED THAT THE TIPS MOVED FREELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21396542 ↗
• MalfunctionFeb 18, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP CORONARY OSTIAL PERFUSION CANNULAE, THE CUSTOMER REPORTED THAT THEY HAVE OBSERVED THAT THE TIPS ON ALL THE DEVICES OF VARIOUS LOT NUMBERS WERE ALL ROTATING BY THEMSELVES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIPS WERE NOT OBSTRUCTED. IT WAS NOTICED THAT THE TIPS EASILY DETACHED FROM THE C CANNULAE BODIES. THE CANNULAE WERE NOT HEATED OR COOLED PRIOR TO USE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE TIPS WERE SPINNING WHILE THE CARDIAC SURGEON WAS HOLDING THE CANNULAE AND THEY NOTICED THAT THE TIPS MOVED FREELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21396368 ↗
• MalfunctionFeb 18, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP CORONARY OSTIAL PERFUSION CANNULAE, THE CUSTOMER REPORTED THAT THEY HAVE OBSERVED THAT THE TIPS ON ALL THE DEVICES OF VARIOUS LOT NUMBERS WERE ALL ROTATING BY THEMSELVES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIPS WERE NOT OBSTRUCTED. IT WAS NOTICED THAT THE TIPS EASILY DETACHED FROM THE C CANNULAE BODIES. THE CANNULAE WERE NOT HEATED OR COOLED PRIOR TO USE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE TIPS WERE SPINNING WHILE THE CARDIAC SURGEON WAS HOLDING THE CANNULAE AND THEY NOTICED THAT THE TIPS MOVED FREELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21395714 ↗
• MalfunctionFeb 18, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP CORONARY OSTIAL PERFUSION CANNULAE, THE CUSTOMER REPORTED THAT THEY HAVE OBSERVED THAT THE TIPS ON ALL THE DEVICES OF VARIOUS LOT NUMBERS WERE ALL ROTATING BY THEMSELVES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIPS WERE NOT OBSTRUCTED. IT WAS NOTICED THAT THE TIPS EASILY DETACHED FROM THE C ANNULAE BODIES. THE CANNULAE WERE NOT HEATED OR COOLED PRIOR TO USE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE TIPS WERE SPINNING WHILE THE CARDIAC SURGEON WAS HOLDING THE CANNULAE AND THEY NOTICED THAT THE TIPS MOVED FREELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21394257 ↗
• MalfunctionFeb 18, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP CORONARY OSTIAL PERFUSION CANNULAE, THE CUSTOMER REPORTED THAT THEY HAVE OBSERVED THAT THE TIPS ON ALL THE DEVICES OF VARIOUS LOT NUMBERS WERE ALL ROTATING BY THEMSELVES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIPS WERE NOT OBSTRUCTED. IT WAS NOTICED THAT THE TIPS EASILY DETACHED FROM THE CANNULAE BODIES. THE CANNULAE WERE NOT HEATED OR COOLED PRIOR TO USE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE TIPS WERE SPINNING WHILE THE CARDIAC SURGEON WAS HOLDING THE CANNULAE AND THEY NOTICED THAT THE TIPS MOVED FREELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21393858 ↗
• MalfunctionFeb 18, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP CORONARY OSTIAL PERFUSION CANNULAE, THE CUSTOMER REPORTED THAT THEY HAVE OBSERVED THAT THE TIPS ON ALL THE DEVICES OF VARIOUS LOT NUMBERS WERE ALL ROTATING BY THEMSELVES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIPS WERE NOT OBSTRUCTED. IT WAS NOTICED THAT THE TIPS EASILY DETACHED FROM THE CANNULAE BODIES. THE CANNULAE WERE NOT HEATED OR COOLED PRIOR TO USE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE TIPS WERE SPINNING WHILE THE CARDIAC SURGEON WAS HOLDING THE CANNULAE AND THEY NOTICED THAT THE TIPS MOVED FREELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21393644 ↗
• MalfunctionFeb 18, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP CORONARY OSTIAL PERFUSION CANNULAE, THE CUSTOMER REPORTED THAT THEY HAVE OBSERVED THAT THE TIPS ON ALL THE DEVICES OF VARIOUS LOT NUMBERS WERE ALL ROTATING BY THEMSELVES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIPS WERE NOT OBSTRUCTED. IT WAS NOTICED THAT THE TIPS EASILY DETACHED FROM THE C ANNULAE BODIES. THE CANNULAE WERE NOT HEATED OR COOLED PRIOR TO USE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE TIPS WERE SPINNING WHILE THE CARDIAC SURGEON WAS HOLDING THE CANNULAE AND THEY NOTICED THAT THE TIPS MOVED FREELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21392968 ↗
• MalfunctionFeb 18, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP CORONARY OSTIAL PERFUSION CANNULAE, THE CUSTOMER REPORTED THAT THEY HAVE OBSERVED THAT THE TIPS ON ALL THE DEVICES OF VARIOUS LOT NUMBERS WERE ALL ROTATING BY THEMSELVES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIPS WERE NOT OBSTRUCTED. IT WAS NOTICED THAT THE TIPS EASILY DETACHED FROM THE CANNULAE BODIES. THE CANNULAE WERE NOT HEATED OR COOLED PRIOR TO USE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE TIPS WERE SPINNING WHILE THE CARDIAC SURGEON WAS HOLDING THE CANNULAE AND THEY NOTICED THAT THE TIPS MOVED FREELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21392583 ↗
• MalfunctionFeb 13, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP HIGH FLOW CORONARY ARTERY OSTIAL CANNULAE, IT WAS REPORTED THAT THE HOSPITAL WAREHOUSE CHECKED ALL THE PRODUCTS IN THE HOSPITAL AND MANY OF THE DEVICES HAD A LOOSE SUCTION TIP, BUT THE REST DID NOT. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. THE CUSTOMER STATED THAT IF THE SUCTION TIP WAS LOOSE, IT MIGHT CAUSE THE TIP END TO FALL OFF DURING USE, CAUSING UNNECESSARY TROUBLE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT FOR THE DEVICES RETURNED IN THE SEALED POUCHES, IT WAS DETERMINED THAT SOME OF THESE DEVICES HAD LOOSE TIPS AS THE CUSTOMER TURNED THE TIP THROUGH THE BAG AND OBSERVED THAT THEY WERE LOOSE. THE COMPLAINED PRODUCTS WERE ALL DEFECTIVE AND HAD BEEN CHECKED. THEY WERE CHECKED BY TURNING THE TIP THROUGH THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374951 ↗
• MalfunctionFeb 13, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP HIGH FLOW CORONARY ARTERY OSTIAL CANNULAE, IT WAS REPORTED THAT THE HOSPITAL WAREHOUSE CHECKED ALL THE PRODUCTS IN THE HOSPITAL AND MANY OF THE DEVICES HAD A LOOSE SUCTION TIP, BUT THE REST DID NOT. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. THE CUSTOMER STATED THAT IF THE SUCTION TIP WAS LOOSE, IT MIGHT CAUSE THE TIP END TO FALL OFF DURING USE, CAUSING UNNECESSARY TROUBLE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT FOR THE DEVICES RETURNED IN THE SEALED POUCHES, IT WAS DETERMINED THAT SOME OF THESE DEVICES HAD LOOSE TIPS AS THE CUSTOMER TURNED THE TIP THROUGH THE BAG AND OBSERVED THAT THEY WERE LOOSE. THE COMPLAINED PRODUCTS WERE ALL DEFECTIVE AND HAD BEEN CHECKED. THEY WERE CHECKED BY TURNING THE TIP THROUGH THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374853 ↗
• MalfunctionFeb 13, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP HIGH FLOW CORONARY ARTERY OSTIAL CANNULAE, IT WAS REPORTED THAT THE HOSPITAL WAREHOUSE CHECKED ALL THE PRODUCTS IN THE HOSPITAL AND MANY OF THE DEVICES HAD A LOOSE SUCTION TIP, BUT THE REST DID NOT. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. THE CUSTOMER STATED THAT IF THE SUCTION TIP WAS LOOSE, IT MIGHT CAUSE THE TIP END TO FALL OFF DURING USE, CAUSING UNNECESSARY TROUBLE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT FOR THE DEVICES RETURNED IN THE SEALED POUCHES, IT WAS DETERMINED THAT SOME OF THESE DEVICES HAD LOOSE TIPS AS THE CUSTOMER TURNED THE TIP THROUGH THE BAG AND OBSERVED THAT THEY WERE LOOSE. THE COMPLAINED PRODUCTS WERE ALL DEFECTIVE AND HAD BEEN CHECKED. THEY WERE CHECKED BY TURNING THE TIP THROUGH THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374791 ↗
• MalfunctionFeb 13, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP HIGH FLOW CORONARY ARTERY OSTIAL CANNULAE, IT WAS REPORTED THAT THE HOSPITAL WAREHOUSE CHECKED ALL THE PRODUCTS IN THE HOSPITAL AND MANY OF THE DEVICES HAD A LOOSE SUCTION TIP, BUT THE REST DID NOT. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. THE CUSTOMER STATED THAT IF THE SUCTION TIP WAS LOOSE, IT MIGHT CAUSE THE TIP END TO FALL OFF DURING USE, CAUSING UNNECESSARY TROUBLE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT FOR THE DEVICES RETURNED IN THE SEALED POUCHES, IT WAS DETERMINED THAT SOME OF THESE DEVICES HAD LOOSE TIPS AS THE CUSTOMER TURNED THE TIP THROUGH THE BAG AND OBSERVED THAT THEY WERE LOOSE. THE COMPLAINED PRODUCTS WERE ALL DEFECTIVE AND HAD BEEN CHECKED. THEY WERE CHECKED BY TURNING THE TIP THROUGH THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374753 ↗
• MalfunctionFeb 13, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP HIGH FLOW CORONARY ARTERY OSTIAL CANNULAE, IT WAS REPORTED THAT THE HOSPITAL WAREHOUSE CHECKED ALL THE PRODUCTS IN THE HOSPITAL AND MANY OF THE DEVICES HAD A LOOSE SUCTION TIP, BUT THE REST DID NOT. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. THE CUSTOMER STATED THAT IF THE SUCTION TIP WAS LOOSE, IT MIGHT CAUSE THE TIP END TO FALL OFF DURING USE, CAUSING UNNECESSARY TROUBLE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT FOR THE DEVICES RETURNED IN THE SEALED POUCHES, IT WAS DETERMINED THAT SOME OF THESE DEVICES HAD LOOSE TIPS AS THE CUSTOMER TURNED THE TIP THROUGH THE BAG AND OBSERVED THAT THEY WERE LOOSE. THE COMPLAINED PRODUCTS WERE ALL DEFECTIVE AND HAD BEEN CHECKED. THEY WERE CHECKED BY TURNING THE TIP THROUGH THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374746 ↗
• MalfunctionFeb 13, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP HIGH FLOW CORONARY ARTERY OSTIAL CANNULAE, IT WAS REPORTED THAT THE HOSPITAL WAREHOUSE CHECKED ALL THE PRODUCTS IN THE HOSPITAL AND MANY OF THE DEVICES HAD A LOOSE SUCTION TIP, BUT THE REST DID NOT. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. THE CUSTOMER STATED THAT IF THE SUCTION TIP WAS LOOSE, IT MIGHT CAUSE THE TIP END TO FALL OFF DURING USE, CAUSING UNNECESSARY TROUBLE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT FOR THE DEVICES RETURNED IN THE SEALED POUCHES, IT WAS DETERMINED THAT SOME OF THESE DEVICES HAD LOOSE TIPS AS THE CUSTOMER TURNED THE TIP THROUGH THE BAG AND OBSERVED THAT THEY WERE LOOSE. THE COMPLAINED PRODUCTS WERE ALL DEFECTIVE AND HAD BEEN CHECKED. THEY WERE CHECKED BY TURNING THE TIP THROUGH THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374669 ↗
• MalfunctionFeb 13, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP HIGH FLOW CORONARY ARTERY OSTIAL CANNULAE, IT WAS REPORTED THAT THE HOSPITAL WAREHOUSE CHECKED ALL THE PRODUCTS IN THE HOSPITAL AND MANY OF THE DEVICES HAD A LOOSE SUCTION TIP, BUT THE REST DID NOT. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. THE CUSTOMER STATED THAT IF THE SUCTION TIP WAS LOOSE, IT MIGHT CAUSE THE TIP END TO FALL OFF DURING USE, CAUSING UNNECESSARY TROUBLE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT FOR THE DEVICES RETURNED IN THE SEALED POUCHES, IT WAS DETERMINED THAT SOME OF THESE DEVICES HAD LOOSE TIPS AS THE CUSTOMER TURNED THE TIP THROUGH THE BAG AND OBSERVED THAT THEY WERE LOOSE. THE COMPLAINED PRODUCTS WERE ALL DEFECTIVE AND HAD BEEN CHECKED. THEY WERE CHECKED BY TURNING THE TIP THROUGH THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374612 ↗
• MalfunctionFeb 13, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP HIGH FLOW CORONARY ARTERY OSTIAL CANNULAE, IT WAS REPORTED THAT THE HOSPITAL WAREHOUSE CHECKED ALL THE PRODUCTS IN THE HOSPITAL AND MANY OF THE DEVICES HAD A LOOSE SUCTION TIP, BUT THE REST DID NOT. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. THE CUSTOMER STATED THAT IF THE SUCTION TIP WAS LOOSE, IT MIGHT CAUSE THE TIP END TO FALL OFF DURING USE, CAUSING UNNECESSARY TROUBLE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT FOR THE DEVICES RETURNED IN THE SEALED POUCHES, IT WAS DETERMINED THAT SOME OF THESE DEVICES HAD LOOSE TIPS AS THE CUSTOMER TURNED THE TIP THROUGH THE BAG AND OBSERVED THAT THEY WERE LOOSE. THE COMPLAINED PRODUCTS WERE ALL DEFECTIVE AND HAD BEEN CHECKED. THEY WERE CHECKED BY TURNING THE TIP THROUGH THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374605 ↗
• MalfunctionFeb 13, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP HIGH FLOW CORONARY ARTERY OSTIAL CANNULAE, IT WAS REPORTED THAT THE HOSPITAL WAREHOUSE CHECKED ALL THE PRODUCTS IN THE HOSPITAL AND MANY OF THE DEVICES HAD A LOOSE SUCTION TIP, BUT THE REST DID NOT. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. THE CUSTOMER STATED THAT IF THE SUCTION TIP WAS LOOSE, IT MIGHT CAUSE THE TIP END TO FALL OFF DURING USE, CAUSING UNNECESSARY TROUBLE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT FOR THE DEVICES RETURNED IN THE SEALED POUCHES, IT WAS DETERMINED THAT SOME OF THESE DEVICES HAD LOOSE TIPS AS THE CUSTOMER TURNED THE TIP THROUGH THE BAG AND OBSERVED THAT THEY WERE LOOSE. THE COMPLAINED PRODUCTS WERE ALL DEFECTIVE AND HAD BEEN CHECKED. THEY WERE CHECKED BY TURNING THE TIP THROUGH THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374445 ↗
• MalfunctionFeb 13, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE DLP HIGH FLOW CORONARY ARTERY OSTIAL CANNULAE, IT WAS REPORTED THAT THE HOSPITAL WAREHOUSE CHECKED ALL THE PRODUCTS IN THE HOSPITAL AND MANY OF THE DEVICES HAD A LOOSE SUCTION TIP, BUT THE REST DID NOT. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. THE CUSTOMER STATED THAT IF THE SUCTION TIP WAS LOOSE, IT MIGHT CAUSE THE TIP END TO FALL OFF DURING USE, CAUSING UNNECESSARY TROUBLE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT FOR THE DEVICES RETURNED IN THE SEALED POUCHES, IT WAS DETERMINED THAT SOME OF THESE DEVICES HAD LOOSE TIPS AS THE CUSTOMER TURNED THE TIP THROUGH THE BAG AND OBSERVED THAT THEY WERE LOOSE. THE COMPLAINED PRODUCTS WERE ALL DEFECTIVE AND HAD BEEN CHECKED. THEY WERE CHECKED BY TURNING THE TIP THROUGH THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374396 ↗

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