DLP® 12113Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20643169881338), received between Apr 14, 2023 and Sep 9, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (5 reports).

2 FDA recall records name this device's identifier, 2 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-2480-2025 · Root cause: Process change control · FDA record ↗

2. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP LEFT HEART VENT CATHETER, IT WAS REPORTED THAT THE METAL IN THE PRODUCT SEEMS DIFFERENT. IT IS THICKER AND STIFFER THAN BEFORE AND DOES NOT HOLD ITS SHAPE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. THE CUSTOMER IS ASKING IF THE WIRE WAS CHANGED OR SOMETHING WAS CHANGED IN THE DESIGN. THERE ARE PICTURES COMPARING IT TO THE 15 FRENCH AND THE WIRE LOOKS WAY BIGGER IN THE 13 FRENCH AGAINST THE OLD 15 FRENCH. UNOPENED PACKAGES WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23001568 ↗
• MalfunctionJun 4, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT PRIOR TO USE OF A DLP LEFT HEART VENT CATHETER, THE CUSTOMER STATED THAT THE CANNULA DID NOT BEND LIKE IT NORMALLY DOES. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22139661 ↗
• MalfunctionJan 20, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP LEFT HEART VENT CATHETER, THE CUSTOMER REPORTED THAT THE WIRE WAS NOT STIFF ENOUGH AND WOULD NOT HOLD A BEND. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21191451 ↗
• MalfunctionDec 6, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP LEFT HEART VENT CATHETER, IT WAS REPORTED THAT THE CANNULA DID NOT BEND AS IT USUALLY DOES, POSSIBLY INDICATING A DIFFERENT WIRE WAS USED. THE CUSTOMER THOUGHT THAT IT WAS DIFFERENT FROM WHAT WAS TYPICALLY USED. THE DEVICE WAS USED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20861932 ↗
• MalfunctionJan 29, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP LEFT HEART VENT CATHETER, IT WAS REPORTED THAT THE CUSTOMER DID NOT FEEL THE WIRE REINFORCEMENTS HELD THE SHAPE OF THE VENT AS HE WAS PLACING IT IN THE HEART. THE CUSTOMER BELIEVES THERE WAS SOME KIND OF CHANGE TO THE MATERIAL OR MANUFACTURING OF THE CANNULA AND WOULD LIKE IT EXAMINED TO MAKE SURE NOTHING HAS CHANGED. THERE WAS NO BLOOD LOSS AND NO HARM TO THE PATIENT. 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 18594436 ↗
• MalfunctionApr 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP LEFT HEART VENT CATHETERS, IT WAS REPORTED THAT AFTER THE VENT WAS INSERTED INTO THE PATIENT, THERE WAS A VERY SMALL BLOOD LEAK (A FEW MILLILITERS MAXIMUM) FROM THE REGION OF THE LUER LOCK CONNECTOR. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. THERE WAS NO BLOOD LOSS AND NO DAMAGE SEEN TO ANY PACKAGING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16740982 ↗

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-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
• Z-2481-2025 · Aug 6, 2025 · Open, Classified
  DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110