DLP® 30014Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20613994576020), received between Jul 24, 2023 and May 1, 2026 — classified as 1 death, 5 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP CORONARY ARTERY OSTIAL CANNULA, IT WAS REPORTED THAT DURING A MVR (MITRAL VALVE REPLACEMENT), AVR (AORTIC VALVE REPLACEMENT) AND LAA (LEFT ATRIAL APPENDAGE) IN A YOUNG PATIENT, THERE WAS A LARGE ANTEGRADE DOSE WITH QUICK ARREST AT THE ONSET OF THE CASE. AI (AORTIC INSUFFICIENCY) OSTIAL PLEGIA WAS DELIVERED FOR MOST OF THE CASE. THE SURGICAL PREFERENCE WAS TO UTILIZE TWO SEPARATE HANDHELD DLP 30014 DEVICES FOR THE RIGHT AND LEFT OSTIA'S. THE CUSTOMER STARTED BY INITIATING THE RIGHT, THEN UNCLIPPED THE LEFT. THE CORONARY ANATOMY WAS NON-REMARKABLE. THE SURGEON CHECKED THE MYOCARDIAL TEMPERATURE MANUALLY FROM TIME TO TIME AND FOUND THE LV (LEFT VENTRICLE) TEMPERATURE SATISFACTORY, BUT AFTER UNCLAMPING, THE HEART WENT INTO INTRACTABLE VT (VENTRICULAR TACHYCARDIA) WITH AN AKINETIC LV (LEFT VENTRICLE). EVENTUALLY THE CUSTOMER RE-CLAMPED, GAVE PLEGE AND THE LV (LEFT VENTRICLE) RECOVERED TO SUPPORT OFF PUMP, ALTHOUGH THE PATIENT LUNGS WERE FLOODED IN THE PROCESS. THE PATIENT HAS AN OPEN STERNUM ON VV ECMO (VENO-VENOUS EXTRACORPOREAL MEMBRANE OXYGENATION) CURRENTLY. AFTER THE CUSTOMER RE-CLAMPED, THEY FOUND THE LIKELY CULPRIT OF THE PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25054789 ↗
• MalfunctionJan 29, 2026Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP CORONARY ARTERY OSTIAL CANNULA, IT WAS REPORTED THAT THE DEVICE WAS COMPLETELY BLOCKED AND THERE WAS NO FLOW AT ALL THROUGH THE CANNULA. THE INSTRUMENT 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 24211059 ↗
• DeathDec 23, 2025Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP CORONARY ARTERY OSTIAL CANNULA, IT WAS REPORTED THAT DURING MVR (MITRAL VALVE REPLACEMENT), AVR (AORTIC VALVE REPLACEMENT) AND LAA (LAA  LEFT ATRIAL APPENDAGE) IN YOUNG PATIENT, THERE WAS A LARGE ANTEGRADE DOSE WITH QUICK ARREST AT THE ONSET OF THE CASE. AI (AORTIC INSUFFICIENCY) OSTIAL PLEGIA WAS DELIVERED FOR MOST OF THE CASE. THE SURGICAL PREFERENCE WAS TO UTILIZE 2 SEPARATE HANDHELD DLP 30014 DEVICES FOR THE RIGHT AND LEFT OSTIA'S. CUSTOMER STARTED BY INITIATING THE RIGHT, THEN UNCLIPPED THE LEFT. NON REMARKABLE CORONARY ANATOMY. SURGEON DID CHECK FOR MYOCARDIAL TEMP MANUALLY FROM TIME TO TIME AND FOUND THE LV ( LEFT VENTRICLE) TEMP SATISFACTORY, BUT AFTER UNCLAMPING THE HEART WENT INTO INTRACTABLE VT (VENTRICULAR TACHYCARDIA) WITH AN AKINETIC LV (LEFT VENTRICLE). EVENTUALLY CUSTOMER RE-CLAMP GAVE PLEGE AND THE LV (LEFT VENTRICLE) RECOVERED TO SUPPORT OFF PUMP, ALTHOUGH PATIENT LUNGS WAS FLOODED IN THE PROCESS. PATIENT HAS AN OPEN STERNUM ON VV (VENO-VENOUS) ECMO CURRENTLY. AFTER CUSTOMER RE-CLAMP, THEY FOUND THE LIKELY CULPRIT OF THE PROBLEM AS A BLOCKED HANDHELD CANNULA. THE RCA CANNULA DELIVERS 200CC/MIN AT 250MMHG WHIL

  Patient problems: Pulmonary Edema; Tachycardia

  MAUDE report 23875239 ↗
• MalfunctionSep 17, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT PRIOR TO USE THE DLP CORONARY ARTERY OSTIAL CANNULA WAS ALLEGED TO HAVE AN OCCLUSION OF THE CORONARY OSTIAL CANNULA. 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 23070647 ↗
• MalfunctionAug 29, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT DURING USE OF DLP CORONARY ARTERY OSTIAL CANNULA , THE MYOCARDIAL PROTECTION SOLUTION COULD NOT FLOW PROPERLY DUE TO AN OBSTRUCTION IN THE DEVICE. THE BLOCKAGE IN THE INTERNAL TUBING PREVENTED NORMAL PERFUSION OF THE MYOCARDIAL PROTECTION SOLUTION, CAUSING AN INCREASE IN PUMP PRESSURE. THE DEVICE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22920641 ↗
• MalfunctionJul 24, 2023Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP CORONARY ARTERY OSTIAL CANNULA, IT WAS REPORTED THAT THE CANNULA WAS CLOGGED. THE DEVICE WAS REPLACED FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17378316 ↗

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