DLP® 12112Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20613994619277), received between Jan 6, 2025 and Feb 10, 2026 — classified as 1 death, 2 malfunctions.

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

2 other recalls cover devices cleared under the same FDA submission (K850385); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathFeb 10, 2026Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP PERICARDIAL/INTRACARDIAC SUMP, IT WAS REPORTED THAT IT HAD A PROBLEM. THE DEVICE WAS REPLACED DURING THE PROCEDURE. THE PATIENT PASSED AWAY. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE SURGEON STATED THAT DURING USE THEY NOTICED THAT THE DEVICE HAD TOUCHED THE LATERAL WALL OF THE LEFT VENTRICLE, WITH THE RISK OF PERFORATION. THERE WAS AN IMPACT TO THE PATIENT AS A SECOND SURGERY WAS PERFORMED TO REPAIR THE LESION IN THE PATIENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PATIENT IS NOW DECEASED FOLLOWING REPEATED SURGERIES. A PERFORATION OF THE LATERAL WALL WAS CONFIRMED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE EXACT CAUSE OF DEATH WAS NOT IDENTIFIED. THE PATIENT'S DEATH WAS NOT BELIEVED TO BE LINKED TO THE PERFORMANCE OF THE DLP PERICARDIAL/INTRACARDIAC SUMP.

  Patient problems: Perforation

  MAUDE report 24301875 ↗
• MalfunctionMay 22, 2025Contamination; Contamination

  IT WAS REPORTED THAT PRIOR TO USE OF A DLP PERICARDIAL/INTRACARDIAC SUMP, A HAIR WAS OBSERVED IN THE STERILE PACKAGING. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22069460 ↗
• MalfunctionJan 6, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT UPON OPENING THE STERILE PACKAGING OF THE DLP PERICARDIAL/INTRACARDIAC SUMP, A DAMAGED CONNECTOR WAS DISCOVERED, RENDERING THE DEVICE UNUSABLE. THERE WAS NO DAMAGE TO THE EXTERNAL PACKAGING AND THE DEVICE WAS STORED IN ITS ORIGINAL CARDBOARD OUTER PACKAGING UNTIL NEEDED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078106 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K850385. One submission often covers many models, so check the product and lot details in each record.

• Z-1797-2024 · Mar 19, 2024 · Open, Classified
  Medtronic Left Heart Vent Catheters: a) DLP Intracardiac Sump 20 Fr, Model Number 12012, b) DLP Left Heart Vent Catheter 10 Fr., Model Number 12008, c) DLP Left Heart Vent Cath
• Z-0609-2009 · Sep 29, 2008 · Terminated
  DLP(R) Pericardial/Intracardiac Sump Cannulae, 20 Fr., P/N: 12112. This product is intended for draining the pericardial sac or the cardiac chambers.