DLP® 30112Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 20613994575986), received between Feb 6, 2025 and Feb 18, 2025 — classified as 41 malfunctions.

The most frequently reported specific device problem is “Material Separation” (41 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 41 reports, in the reporter's own words as published by the FDA.

• 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 21399883 ↗
• 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 21397566 ↗
• 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 21395011 ↗
• 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 21394371 ↗
• 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 21394310 ↗
• 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 21394032 ↗
• 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 21393989 ↗
• 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 21392664 ↗
• 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 21392510 ↗
• 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 21372887 ↗
• 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 21372872 ↗
• 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 21372860 ↗
• 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 21372813 ↗
• 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 21372802 ↗
• 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 21372800 ↗
• 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 21372749 ↗
• 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 21372719 ↗
• 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 21372713 ↗
• 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 21372710 ↗
• 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 21372669 ↗
• 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 21372664 ↗
• 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 21372628 ↗
• 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 21372604 ↗
• 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 21372570 ↗
• 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 21372306 ↗

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