DLP® 30155Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 20613994575962), received between Mar 3, 2025 and Mar 4, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Material Separation” (16 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.

• MalfunctionMar 4, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT THE ISSUE WITH THE UNUSED DEVICE WAS DISCOVERED UPON CHECKING THE STOCK AFTER THE PROCEDURE. IT WAS REPORTED THAT THE JOINT AT THE TIP BETWEEN THE ADVANCED PLASTIC AND METAL ROTATES. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIP WAS NOT OBSTRUCTED. THE TIP DID NOT DETACH FROM THE CANNULA BODY. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21515126 ↗
• MalfunctionMar 4, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT THE ISSUE WITH THE UNUSED DEVICE WAS DISCOVERED UPON CHECKING THE STOCK AFTER THE PROCEDURE. IT WAS REPORTED THAT THE JOINT AT THE TIP BETWEEN THE ADVANCED PLASTIC AND METAL ROTATES. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIP WAS NOT OBSTRUCTED. THE TIP DID NOT DETACH FROM THE CANNULA BODY. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21515097 ↗
• MalfunctionMar 3, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE, AT INVENTORY CHECK OF A DLP HIGH FLOW CORONARY ARTERY OSTIAL CANNULA, IT WAS REPORTED THAT THE PLASTIC-METAL BOND AT THE TIP WAS TWIRLED. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIP WAS NOT OBSTRUCTED. THE TIP DID NOT DETACH FROM THE CANNULA BODY. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21504030 ↗
• MalfunctionMar 3, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE, AT INVENTORY CHECK OF A DLP HIGH FLOW CORONARY ARTERY OSTIAL CANNULA, IT WAS REPORTED THAT THE PLASTIC-METAL BOND AT THE TIP WAS TWIRLED. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIP WAS NOT OBSTRUCTED. THE TIP DID NOT DETACH FROM THE CANNULA BODY. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503970 ↗
• MalfunctionMar 3, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE, AT INVENTORY CHECK OF A DLP HIGH FLOW CORONARY ARTERY OSTIAL CANNULA, IT WAS REPORTED THAT THE PLASTIC-METAL BOND AT THE TIP WAS TWIRLED. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIP WAS NOT OBSTRUCTED. THE TIP DID NOT DETACH FROM THE CANNULA BODY. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503864 ↗
• MalfunctionMar 3, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE, AT INVENTORY CHECK OF A DLP HIGH FLOW CORONARY ARTERY OSTIAL CANNULA, IT WAS REPORTED THAT THE PLASTIC-METAL BOND AT THE TIP WAS TWIRLED. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIP WAS NOT OBSTRUCTED. THE TIP DID NOT DETACH FROM THE CANNULA BODY. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503762 ↗
• MalfunctionMar 3, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE, AT INVENTORY CHECK OF A DLP HIGH FLOW CORONARY ARTERY OSTIAL CANNULA, IT WAS REPORTED THAT THE PLASTIC-METAL BOND AT THE TIP WAS TWIRLED. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIP WAS NOT OBSTRUCTED. THE TIP DID NOT DETACH FROM THE CANNULA BODY. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503614 ↗
• MalfunctionMar 3, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE, AT INVENTORY CHECK OF A DLP HIGH FLOW CORONARY ARTERY OSTIAL CANNULA, IT WAS REPORTED THAT THE PLASTIC-METAL BOND AT THE TIP WAS TWIRLED. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIP WAS NOT OBSTRUCTED. THE TIP DID NOT DETACH FROM THE CANNULA BODY. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503261 ↗
• MalfunctionMar 3, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE, AT INVENTORY CHECK OF A DLP HIGH FLOW CORONARY ARTERY OSTIAL CANNULA, IT WAS REPORTED THAT THE PLASTIC-METAL BOND AT THE TIP WAS TWIRLED. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIP WAS NOT OBSTRUCTED. THE TIP DID NOT DETACH FROM THE CANNULA BODY. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503230 ↗
• MalfunctionMar 3, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE, AT INVENTORY CHECK OF A DLP HIGH FLOW CORONARY ARTERY OSTIAL CANNULA, IT WAS REPORTED THAT THE PLASTIC-METAL BOND AT THE TIP WAS TWIRLED. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIP WAS NOT OBSTRUCTED. THE TIP DID NOT DETACH FROM THE CANNULA BODY. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503190 ↗
• MalfunctionMar 3, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE, AT INVENTORY CHECK OF A DLP HIGH FLOW CORONARY ARTERY OSTIAL CANNULA, IT WAS REPORTED THAT THE PLASTIC-METAL BOND AT THE TIP WAS TWIRLED. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIP WAS NOT OBSTRUCTED. THE TIP DID NOT DETACH FROM THE CANNULA BODY. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503148 ↗
• MalfunctionMar 3, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE, AT INVENTORY CHECK OF A DLP HIGH FLOW CORONARY ARTERY OSTIAL CANNULA, IT WAS REPORTED THAT THE PLASTIC-METAL BOND AT THE TIP WAS TWIRLED. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIP WAS NOT OBSTRUCTED. THE TIP DID NOT DETACH FROM THE CANNULA BODY. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503079 ↗
• MalfunctionMar 3, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE, AT INVENTORY CHECK OF A DLP HIGH FLOW CORONARY ARTERY OSTIAL CANNULA, IT WAS REPORTED THAT THE PLASTIC-METAL BOND AT THE TIP WAS TWIRLED. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIP WAS NOT OBSTRUCTED. THE TIP DID NOT DETACH FROM THE CANNULA BODY. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503035 ↗
• MalfunctionMar 3, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE, AT INVENTORY CHECK OF A DLP HIGH FLOW CORONARY ARTERY OSTIAL CANNULA, IT WAS REPORTED THAT THE PLASTIC-METAL BOND AT THE TIP WAS TWIRLED. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIP WAS NOT OBSTRUCTED. THE TIP DID NOT DETACH FROM THE CANNULA BODY. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503026 ↗
• MalfunctionMar 3, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE, AT INVENTORY CHECK OF A DLP HIGH FLOW CORONARY ARTERY OSTIAL CANNULA, IT WAS REPORTED THAT THE PLASTIC-METAL BOND AT THE TIP WAS TWIRLED. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIP WAS NOT OBSTRUCTED. THE TIP DID NOT DETACH FROM THE CANNULA BODY. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503009 ↗
• MalfunctionMar 3, 2025Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE, AT INVENTORY CHECK OF A DLP HIGH FLOW CORONARY ARTERY OSTIAL CANNULA, IT WAS REPORTED THAT THE PLASTIC-METAL BOND AT THE TIP WAS TWIRLED. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIP WAS NOT OBSTRUCTED. THE TIP DID NOT DETACH FROM THE CANNULA BODY. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21502951 ↗

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