DLP® 12110 (UDI 20763000946436)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20763000946436), received between Feb 18, 2025 and Jul 31, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 reports).

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

2 other recalls cover devices cleared under the same FDA submission (K834039); 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. Aug 6, 2025Open, Classified

   The catheters may not retain their shape.

   Z-2481-2025 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP LEFT HEART VENT CATHETER, IT WAS REPORTED THAT RECENT PRODUCTS HAVE MUCH STIFFER WIRES THAT SPRING UP, UNLIKE BEFORE. THE CUSTOMER IS REQUESTING WHETHER THE DEVICE SPECIFICATIONS HAVE BEEN CHANGED. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO OTHER ISSUES OBSERVED WITH THE DEVICE OTHER THAN THE STIFFNESS OF THE TIP WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22675422 ↗
• InjuryJun 23, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING USE OF THE DLP LEFT HEART VENT CATHETER, SURGEONS OBSERVED INCREASED STIFFNESS OF THE CANNULA, MAKING IT MORE DIFFICULT TO BEND INTO THE DESIRED POSITION. THERE ARE CONCERNS WHETHER THERE HAS BEEN A BAD BATCH OR HAS THERE BEEN A PERMANENT CHANGE WITH THESE CATHETERS. THE USE OF THE DEVICE WAS UNSPECIFIED. IT WAS UNKNOWN IF THERE WERE ANY  COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22305839 ↗
• MalfunctionMar 25, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE DLP LEFT HEART VENT CATHETER, THE CANNULA DID NOT HOLD ITS POSITION AND STRAIGHTENED AFTER BEING BENT INTO PLACE. THE SURGEON NOTED THAT THIS ISSUE HAD BEEN OCCURRING FOR ABOUT A MONTH, DESPITE HAVING USED THE CANNULA IN THE PULMONARY ARTERY DURING PULMONARY THROMBOENDARTERECTOMIES (PTES) FOR YEARS WITHOUT SUCH PROBLEMS. THE USE OF THE DEVICE WAS UNSPECIFIED. NO IMPACT TO THE PATIENT WAS ASSOCIATED WITH THIS EVENT, AND THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21686345 ↗
• MalfunctionFeb 18, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP LEFT HEART VENT CATHETER, IT WAS REPORTED THAT THE GUIDEWIRE WAS NOT FORMING THE CANNULA INTO THE DESIRED POSITION. IT WAS BENDING BACK TOWARDS ITS ORIGINAL POSITION. THE CUSTOMER WAS TRYING TO FORM THE CANNULA INTO THE DEVICE'S INTENDED USE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21399819 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K834039. One submission often covers many models, so check the product and lot details in each record.

• Z-2480-2025 · Aug 6, 2025 · Open, Classified
  DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
• Z-2482-2025 · Aug 6, 2025 · Open, Classified
  DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115