DLP® 12010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20613994619215), received between Oct 17, 2017 and May 23, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 19, 2024Open, Classified

   Potential for unsealed sterile packing.

   Z-1797-2024 · Root cause: Process control · FDA record ↗

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.

• InjuryMay 23, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP PERICARDIAL SUMP, IT WAS REPORTED THAT THE TIP OF THE SUMP GOT CAUGHT IN THE MITRAL VALVE CHORDAE, THE TIP EXTENDED AND TRAPPED THE CHORDAE. THE SURGEON THEN HAD TO CUT THE TIP OF THE SUMP WITH A WIRE CUTTER TO FREE THE CHORDAE. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER BELIEVES THE EVENT TO BE RELATED TO THE DEVICE DUE TO THE CONSTRUCTION OF THE WEIGHTED TIP OF THE DEVICE AND HOW THE RINGS MANAGED TO CATCH THE CHORDAE.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16982312 ↗
• InjurySep 14, 2022Material Separation; Material Deformation; Material Separation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP PERICARDIAL SUMP IN THE CARDIOVASCULAR OPERATING ROOM (CVOR) DURING A MINI-VALVE CASE, THE PERICARDIAL SUMP WAS TUNNELED TO THE CARDIAC CHAMBER BUT NOT PASSED THROUGH THE VALVE. WHEN THE SURGEON WENT TO PULL THE PERICARDIAL SUMP BACK THE WEIGHTED BALL TIP SLIPPED OFF THE END OF THE SUMP AND THE METAL WIRE CAME UNRAVELED. AN X-RAY WAS PERFORMED AND THORACIC SURGEONS CAME IN TO ASSIST IN A LAPAROSCOPIC REMOVAL OF THE WEIGHTED BALL TIP. THERE WERE NO ADDITIONAL REPORTED ADVERSE PATIENT EFFECTS BECAUSE OF THIS ISSUE. THE CUSTOMER STATED THAT THERE WERE NO UNREMOVED FOREIGN OBJECTS (URFO) AS IT WAS DISCOVERED AND RESOLVED DURING THE PROCEDURE. THE CUSTOMER STATED THAT THE ISSUE WITH THIS SUMP IS THAT THE WEIGHTED BALL AND WIRE ARE EXTERNAL ON THE END OF THE SUMP. IN THE ORIGINAL PRODUCT THEY USED, THEY WERE INCASED IN THE SUMP ITSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15416694 ↗
• InjuryOct 17, 2017Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  MEDTRONIC RECEIVED INFORMATION THAT DURING AN AORTIC VALVE PROCEDURE, THE CUSTOMER PASSED THIS PERICARDIAL SUMP THROUGH THE AORTIC VALVE AND THE METAL SPRING ON THE TIP OF THE DEVICE BECAME TANGLED IN THE CHORDAE TENDONAE OF THE MITRAL VALVE. THE CUSTOMER WORKED FOR APPROXIMATELY 20 MINUTES TO GET THE DEVICE UNWRAPPED FROM THE CHORDAE WITHOUT SUCCESS. THE DEVICE HAD TO BE CUT INTO PIECES WITH A WIRE CUTTER IN ORDER TO BE REMOVED. AFTER REMOVING AND COMING OFF BYPASS, THE ECHOCARDIOGRAM SHOWED SEVERE MITRAL REGURGITATION. DUE TO THE PATIENT'S NATIVE MITRAL LEAFLETS BEING THICK, THE CUSTOMER WAS UNABLE TO REPAIR THE VALVE AND SUBSEQUENTLY HAD TO REPLACE IT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 6956049 ↗

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-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.