DLP® 20014LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20613994495550), received between Jul 26, 2024 and Jul 26, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2024Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP AORTIC ROOT CANNULAE WITH A VENT LINE, IT WAS REPORTED THAT THE PATIENT HAD SURGERY FOR A REPLACEMENT AORTIC VALVE WITH A 23MM MECHANICAL HEART VALVE. THE PATIENT HAD A THYECTOMY REPAIR AORTIC ANEURYSM WITH A 30MM STRAIGHT GELWEAVE GRAFT WITH A CARDIOPULMOARY BYPASS. THE PATIENT HAD AN ENCOMPASS MAZE PROCEDURE AND A LIGATION OF THE LEFT ATRIAL APPENDAGE WITH A 40MM ATRICLIP. THE ECHOCARDIOGRAPHY TRANSESOPHAGEAL AORTIC ROOT CANNULA WAS BEING REMOVED FROM THE PATIENT AND THE CATHETER TIP BROKE OFF POSSIBLY INSIDE THE PATIENT. IT WAS UNCLEAR WHETHER IT BROKE OFF INSIDE THE AORTA OR WITHIN THE PARACARDIAL SPACE. THE PATIENT WAS ON 16 MEQ, ACETYLSALICYLIC ACID (ASA) 81MG, COUMADIN, POTASSIUM CHLORIDE (KLOR-CON) PER SLIDING SCALE, 40MG OF LASIX IV BID, 25MG OF LOPRESSOR, 90MG OF MESTINON, MULTIPLE ORGAN DYSFUNCTION (MOD) PAIN, 1200MG OF MUCINEX, 1-2 TABLETS OF NORCO, Q6HR PRN NOVOLOG INSULIN, 200MG OF PAIN AMIODRONE, 40MG OF PRILOSEC, 2 TABLETS OF SENOKOT AND 650MG OF TYLENOL Q4HR PRN. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19836677 ↗