DLP® 12110 (UDI 20643169880676)Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 20643169880676), received between Aug 13, 2024 and Jul 3, 2025 — classified as 3 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (19 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A DLP LEFT HEART VENT CATHETER, IT WAS REPORTED THAT THE VENT WAS NOT AS MALLEABLE AS IT WAS BEFORE, AND THE CUSTOMER ASKED WHETHER THERE WAS ANY CHANGE IN THE CANNULA¿S MATERIAL OR COMPONENTS. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22400775 ↗
• InjuryJul 2, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT SURGEONS OBSERVED INCREASED STIFFNESS OF THE DLP LEFT HEART VENT CATHETER, 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 22383101 ↗
• InjuryMar 25, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE DLP LEFT HEART VENT CATHETER , THE TIP OF THE VENT PERFORATED THE LEFT ATRIUM. THE MALLEABLE VENT WAS NOTED TO BE MUCH STIFFER THAN NORMAL AND WOULD NOT REMAIN IN THE DESIRED PLACE OR SHAPE. AS A RESULT, THE SURGEON HAD TO PAUSE THE CASE TO REPAIR THE ATRIUM TO PREVENT BLEEDING. THE DEVICE WAS CONTINUED TO BE USED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Perforation of Vessels

  MAUDE report 21685533 ↗
• InjuryFeb 18, 2025Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP LEFT HEART VENT CATHETERS, IT WAS REPORTED THAT THE CASE WAS FOR AN ARCH, VSD WITH DHCA. THE SURGEON NOTED THAT THE 10 FR. VENT (12110) SEEMED STIFFER THAN NORMAL AND WAS NOT HOLDING ITS SHAPE WELL. CUSTOMER COMPLAINED THAT IT WAS APPLYING TORQUE TO THE HEART. DURING THE CASE, THE TISSUE OF THE RIGHT SUPERIOR PULMONARY VEIN, WHERE THE VENT WAS PLACES, TORE AND REQUIRED SURGICAL REPAIR. IT TOOK ABOUT 10 MINUTES TO SURGICALLY REPAIR WITH SUTURES. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 21402847 ↗
• MalfunctionFeb 18, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT PRIOR TO USE OF A DLP LEFT HEART VENT CATHETER, THE DEVICE DID NOT MAINTAIN SHAPE ONCE BENT, INDICATING A POTENTIAL ISSUE WITH THE WIRE OR DUROMETER OF THE PLASTIC. THE CUSTOMER HAS RECENTLY NOTICED THIS CHANGE IN THE VENTS, WHICH ARE SUPPOSED TO BE MALLEABLE, AND QUESTIONED WHETHER THERE WAS A CHANGE IN THE WIRE OR PLASTIC DUROMETER. THIS ISSUE WAS OBSERVED IN THE CURRENT LOT AND THE CUSTOMER STATED THEY HAVE ALMOST STOPPED USING THEM DUE TO THEIR POOR FUNCTIONALITY. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE OBSERVED TO THE DEVICE OR PACKAGING. THE ISSUE WAS ABOUT THE VENT FEELING DIFFERENT AND NOT BEING AS MALLEABLE AS WHAT IT WAS BEFORE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT SIX ADDITIONAL DEVICES HAVE BEEN RETURNED FOR TESTING. IT WAS STATED THAT ALL THESE VENT CATHETERS ARE NOT MALLEABLE LIKE THE ONES THE CUSTOMER ARE USED TO AND THEY HAVE RECEIVED IN THE PAST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21401992 ↗
• MalfunctionFeb 18, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT PRIOR TO USE OF A DLP LEFT HEART VENT CATHETER, THE DEVICE DID NOT MAINTAIN SHAPE ONCE BENT, INDICATING A POTENTIAL ISSUE WITH THE WIRE OR DUROMETER OF THE PLASTIC. THE CUSTOMER HAS RECENTLY NOTICED THIS CHANGE IN THE VENTS, WHICH ARE SUPPOSED TO BE MALLEABLE, AND QUESTIONED WHETHER THERE WAS A CHANGE IN THE WIRE OR PLASTIC DUROMETER. THIS ISSUE WAS OBSERVED IN THE CURRENT LOT AND THE CUSTOMER STATED THEY HAVE ALMOST STOPPED USING THEM DUE TO THEIR POOR FUNCTIONALITY. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE OBSERVED TO THE DEVICE OR PACKAGING. THE ISSUE WAS ABOUT THE VENT FEELING DIFFERENT AND NOT BEING AS MALLEABLE AS WHAT IT WAS BEFORE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT SIX ADDITIONAL DEVICES HAVE BEEN RETURNED FOR TESTING. IT WAS STATED THAT ALL THESE VENT CATHETERS ARE NOT MALLEABLE LIKE THE ONES THE CUSTOMER ARE USED TO AND THEY HAVE RECEIVED IN THE PAST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21400488 ↗
• MalfunctionFeb 18, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT PRIOR TO USE OF A DLP LEFT HEART VENT CATHETER, THE DEVICE DID NOT MAINTAIN SHAPE ONCE BENT, INDICATING A POTENTIAL ISSUE WITH THE WIRE OR DUROMETER OF THE PLASTIC. THE CUSTOMER HAS RECENTLY NOTICED THIS CHANGE IN THE VENTS, WHICH ARE SUPPOSED TO BE MALLEABLE, AND QUESTIONED WHETHER THERE WAS A CHANGE IN THE WIRE OR PLASTIC DUROMETER. THIS ISSUE WAS OBSERVED IN THE CURRENT LOT AND THE CUSTOMER STATED THEY HAVE ALMOST STOPPED USING THEM DUE TO THEIR POOR FUNCTIONALITY. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE OBSERVED TO THE DEVICE OR PACKAGING. THE ISSUE WAS ABOUT THE VENT FEELING DIFFERENT AND NOT BEING AS MALLEABLE AS WHAT IT WAS BEFORE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT SIX ADDITIONAL DEVICES HAVE BEEN RETURNED FOR TESTING. IT WAS STATED THAT ALL THESE VENT CATHETERS ARE NOT MALLEABLE LIKE THE ONES THE CUSTOMER ARE USED TO AND THEY HAVE RECEIVED IN THE PAST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21399364 ↗
• MalfunctionFeb 18, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT PRIOR TO USE OF A DLP LEFT HEART VENT CATHETER, THE DEVICE DID NOT MAINTAIN SHAPE ONCE BENT, INDICATING A POTENTIAL ISSUE WITH THE WIRE OR DUROMETER OF THE PLASTIC. THE CUSTOMER HAS RECENTLY NOTICED THIS CHANGE IN THE VENTS, WHICH ARE SUPPOSED TO BE MALLEABLE, AND QUESTIONED WHETHER THERE WAS A CHANGE IN THE WIRE OR PLASTIC DUROMETER. THIS ISSUE WAS OBSERVED IN THE CURRENT LOT AND THE CUSTOMER STATED THEY HAVE ALMOST STOPPED USING THEM DUE TO THEIR POOR FUNCTIONALITY. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE OBSERVED TO THE DEVICE OR PACKAGING. THE ISSUE WAS ABOUT THE VENT FEELING DIFFERENT AND NOT BEING AS MALLEABLE AS WHAT IT WAS BEFORE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT SIX ADDITIONAL DEVICES HAVE BEEN RETURNED FOR TESTING. IT WAS STATED THAT ALL THESE VENT CATHETERS ARE NOT MALLEABLE LIKE THE ONES THE CUSTOMER ARE USED TO AND THEY HAVE RECEIVED IN THE PAST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21396841 ↗
• MalfunctionFeb 18, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT PRIOR TO USE OF A DLP LEFT HEART VENT CATHETER, THE DEVICE DID NOT MAINTAIN SHAPE ONCE BENT, INDICATING A POTENTIAL ISSUE WITH THE WIRE OR DUROMETER OF THE PLASTIC. THE CUSTOMER HAS RECENTLY NOTICED THIS CHANGE IN THE VENTS, WHICH ARE SUPPOSED TO BE MALLEABLE, AND QUESTIONED WHETHER THERE WAS A CHANGE IN THE WIRE OR PLASTIC DUROMETER. THIS ISSUE WAS OBSERVED IN THE CURRENT LOT AND THE CUSTOMER STATED THEY HAVE ALMOST STOPPED USING THEM DUE TO THEIR POOR FUNCTIONALITY. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE OBSERVED TO THE DEVICE OR PACKAGING. THE ISSUE WAS ABOUT THE VENT FEELING DIFFERENT AND NOT BEING AS MALLEABLE AS WHAT IT WAS BEFORE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT SIX ADDITIONAL DEVICES HAVE BEEN RETURNED FOR TESTING. IT WAS STATED THAT ALL THESE VENT CATHETERS ARE NOT MALLEABLE LIKE THE ONES THE CUSTOMER ARE USED TO AND THEY HAVE RECEIVED IN THE PAST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21396124 ↗
• MalfunctionFeb 18, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT PRIOR TO USE OF A DLP LEFT HEART VENT CATHETER, THE DEVICE DID NOT MAINTAIN SHAPE ONCE BENT, INDICATING A POTENTIAL ISSUE WITH THE WIRE OR DUROMETER OF THE PLASTIC. THE CUSTOMER HAS RECENTLY NOTICED THIS CHANGE IN THE VENTS, WHICH ARE SUPPOSED TO BE MALLEABLE, AND QUESTIONED WHETHER THERE WAS A CHANGE IN THE WIRE OR PLASTIC DUROMETER. THIS ISSUE WAS OBSERVED IN THE CURRENT LOT AND THE CUSTOMER STATED THEY HAVE ALMOST STOPPED USING THEM DUE TO THEIR POOR FUNCTIONALITY. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE OBSERVED TO THE DEVICE OR PACKAGING. THE ISSUE WAS ABOUT THE VENT FEELING DIFFERENT AND NOT BEING AS MALLEABLE AS WHAT IT WAS BEFORE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT SIX ADDITIONAL DEVICES HAVE BEEN RETURNED FOR TESTING. IT WAS STATED THAT ALL THESE VENT CATHETERS ARE NOT MALLEABLE LIKE THE ONES THE CUSTOMER ARE USED TO AND THEY HAVE RECEIVED IN THE PAST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21392158 ↗
• MalfunctionJan 14, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT PRIOR TO USE OF DLP LEFT HEART VENT CATHETERS, THE DEVICE DID NOT MAINTAIN SHAPE ONCE BENT, INDICATING A POTENTIAL ISSUE WITH THE WIRE OR DUROMETER OF THE PLASTIC. THE CUSTOMER HAS RECENTLY NOTICED THIS CHANGE IN THE VENTS, WHICH ARE SUPPOSED TO BE MALLEABLE, AND QUESTIONED WHETHER THERE WAS A CHANGE IN THE WIRE OR PLASTIC DUROMETER. THIS ISSUE WAS OBSERVED IN THE CURRENT LOT AND THE CUSTOMER STATED THEY HAVE ALMOST STOPPED USING THEM DUE TO THEIR POOR FUNCTIONALITY. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21146974 ↗
• MalfunctionJan 13, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT PRIOR TO USE OF A DLP LEFT HEART VENT CATHETER, THE DEVICE DID NOT MAINTAIN SHAPE ONCE BENT, INDICATING A POTENTIAL ISSUE WITH THE WIRE OR DUROMETER OF THE PLASTIC. THE CUSTOMER HAS RECENTLY NOTICED THIS CHANGE IN THE VENTS, WHICH ARE SUPPOSED TO BE MALLEABLE, AND QUESTIONED WHETHER THERE WAS A CHANGE IN THE WIRE OR PLASTIC DUROMETER. THIS ISSUE WAS OBSERVED IN THE CURRENT LOT AND THE CUSTOMER STATED THEY HAVE ALMOST STOPPED USING THEM DUE TO THEIR POOR FUNCTIONALITY. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21136083 ↗
• MalfunctionNov 28, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP LEFT HEART VENT CATHETERS, THE CUSTOMER REPORTED THAT THE DEVICE DOES NOT SEEM TO HOLD THE SHAPE IT IS BENT TO, AS IT ALWAYS HAS IN THE PAST. THE CUSTOMER BENDS THE DEVICE TO THE SHAPE AND ANGLE NEEDED FOR INSERTION BUT THE DEVICE SEEMS TO UNBEND ITSELF. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20804341 ↗
• MalfunctionOct 17, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, IT WAS REPORTED THAT THIS DLP LEFT HEART VENT CATHETER SEEMED TO HAVE CHANGED. THE GUIDEWIRE SEEMED STIFFER THAN USUAL AND DID NOT HOLD ITS SHAPE WHEN IT WAS BENT IN THE DESIRED DIRECTION.THE CUSTOMER WAS CONCERNED ABOUT CAUSING PATIENT INJURY. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20468787 ↗
• MalfunctionOct 16, 2024Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP LEFT HEART VENT CATHETER, IT WAS REPORTED THAT THE CANNULA DID NOT MAINTAIN ITS SHAPE DESPITE THE PRESENCE OF THE METAL ROD. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20459698 ↗
• MalfunctionOct 14, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP LEFT HEART VENT CATHETER, THE SURGEONS ARE REPORTING A VERY STIFF CANNULA AND WORRY ABOUT THE IMPACT ON THE MITRAL. THE USE OF THE DEVICE WAS ASKED BUT UNKNOWN. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20437572 ↗
• MalfunctionOct 8, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP LEFT HEART VENT CATHETER, IT WAS REPORTED THAT THE MEDIAL TIP WAS DIFFICULT TO BEND, STIFFER THAN USUAL. THE USE OF THE DEVICE IS UNKNOWN. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20394244 ↗
• MalfunctionOct 2, 2024Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS DLP LEFT HEART VENT CATHETERS HAD AN ISSUE AND DOES NOT RETAIN ITS SHAPE DESPITE THE PRESENCE OF THE METAL ROD. FAILURE TO MAINTAIN THE DESIRED SHAPE LEADS TO A RISK OF HEART INJURY (PULMONARY VEIN, LEFT ATRIUM OR LEFT VENTRICLE) IN 2-YEAR-OLDS. THE PROBLEM RECURRED 2 TIMES IN A ROW AND 8 CANNULAS WERE OPENED OUT OF THE 10 CONTAINED IN A BOX, AND ALL HAD THE SAME DEFECT. THE SURGEON HAD TO CHANGE THE BATCH NUMBER (NOT COMMUNICATED) IN ORDER TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES FOR THE CHILD, AND NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20350466 ↗
• MalfunctionOct 2, 2024Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS DLP LEFT HEART VENT CATHETERS HAD AN ISSUE AND DOES NOT RETAIN ITS SHAPE DESPITE THE PRESENCE OF THE METAL ROD. FAILURE TO MAINTAIN THE DESIRED SHAPE LEADS TO A RISK OF HEART INJURY (PULMONARY VEIN, LEFT ATRIUM OR LEFT VENTRICLE) IN 2-YEAR-OLDS. THE PROBLEM RECURRED 2 TIMES IN A ROW AND 8 CANNULAS WERE OPENED OUT OF THE 10 CONTAINED IN A BOX, AND ALL HAD THE SAME DEFECT. THE SURGEON HAD TO CHANGE THE BATCH NUMBER (NOT COMMUNICATED) IN ORDER TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES FOR THE CHILD., AND NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20350433 ↗
• MalfunctionOct 2, 2024Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS DLP LEFT HEART VENT CATHETERS HAD AN ISSUE AND DOES NOT RETAIN ITS SHAPE DESPITE THE PRESENCE OF THE METAL ROD. FAILURE TO MAINTAIN THE DESIRED SHAPE LEADS TO A RISK OF HEART INJURY (PULMONARY VEIN, LEFT ATRIUM OR LEFT VENTRICLE) IN 2-YEAR-OLDS. THE PROBLEM RECURRED 2 TIMES IN A ROW AND 8 CANNULAS WERE OPENED OUT OF THE 10 CONTAINED IN A BOX, AND ALL HAD THE SAME DEFECT. THE SURGEON HAD TO CHANGE THE BATCH NUMBER (NOT COMMUNICATED) IN ORDER TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES FOR THE CHILD., AND NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20350425 ↗
• MalfunctionOct 2, 2024Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS DLP LEFT HEART VENT CATHETERS HAD AN ISSUE AND DOES NOT RETAIN ITS SHAPE DESPITE THE PRESENCE OF THE METAL ROD. FAILURE TO MAINTAIN THE DESIRED SHAPE LEADS TO A RISK OF HEART INJURY (PULMONARY VEIN, LEFT ATRIUM OR LEFT VENTRICLE) IN 2-YEAR-OLDS. THE PROBLEM RECURRED 2 TIMES IN A ROW AND 8 CANNULAS WERE OPENED OUT OF THE 10 CONTAINED IN A BOX, AND ALL HAD THE SAME DEFECT. THE SURGEON HAD TO CHANGE THE BATCH NUMBER (NOT COMMUNICATED) IN ORDER TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES FOR THE CHILD., AND NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20350392 ↗
• MalfunctionOct 2, 2024Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS DLP LEFT HEART VENT CATHETERS HAD AN ISSUE AND DOES NOT RETAIN ITS SHAPE DESPITE THE PRESENCE OF THE METAL ROD. FAILURE TO MAINTAIN THE DESIRED SHAPE LEADS TO A RISK OF HEART INJURY (PULMONARY VEIN,LEFT ATRIUM OR LEFT VENTRICLE) IN 2-YEAR-OLDS. THE PROBLEM RECURRED 2 TIMES IN A ROW AND 8 CANNULAS WERE OPENED OUT OF THE 10 CONTAINED IN A BOX, AND ALL HAD THE SAME DEFECT. THE SURGEON HAD TO CHANGE THE BATCH NUMBER (NOT COMMUNICATED) IN ORDER TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES FOR THE CHILD, AND NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20349975 ↗
• MalfunctionOct 2, 2024Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS DLP LEFT HEART VENT CATHETERS HAD AN ISSUE AND DOES NOT RETAIN ITS SHAPE DESPITE THE PRESENCE OF THE METAL ROD. FAILURE TO MAINTAIN THE DESIRED SHAPE LEADS TO A RISK OF HEART INJURY (PULMONARY VEIN, LEFT ATRIUM OR LEFT VENTRICLE) IN 2-YEAR-OLDS. THE PROBLEM RECURRED 2 TIMES IN A ROW AND 8 CANNULAS WERE OPENED OUT OF THE 10 CONTAINED IN A BOX, AND ALL HAD THE SAME DEFECT. THE SURGEON HAD TO CHANGE THE BATCH NUMBER (NOT COMMUNICATED) IN ORDER TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES FOR THE CHILD., AND NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20349967 ↗
• MalfunctionOct 2, 2024Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS DLP LEFT HEART VENT CATHETERS HAD AN ISSUE AND DOES NOT RETAIN ITS SHAPE DESPITE THE PRESENCE OF THE METAL ROD. FAILURE TO MAINTAIN THE DESIRED SHAPE LEADS TO A RISK OF HEART INJURY (PULMONARY VEIN, LEFT ATRIUM OR LEFT VENTRICLE) IN 2-YEAR-OLDS. THE PROBLEM RECURRED 2 TIMES IN A ROW AND 8 CANNULAS WERE OPENED OUT OF THE 10 CONTAINED IN A BOX, AND ALL HAD THE SAME DEFECT. THE SURGEON HAD TO CHANGE THE BATCH NUMBER (NOT COMMUNICATED) IN ORDER TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES FOR THE CHILD., AND NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20349925 ↗
• MalfunctionOct 1, 2024Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS DLP LEFT HEART VENT CATHETERS HAD AN ISSUE AND DOES NOT RETAIN ITS SHAPE DESPITE THE PRESENCE OF THE METAL ROD. FAILURE TO MAINTAIN THE DESIRED SHAPE LEADS TO A RISK OF HEART INJURY (PULMONARY VEIN, LEFT ATRIUM OR LEFT VENTRICLE) IN 2-YEAR-OLDS. THE PROBLEM RECURRED 2 TIMES IN A ROW AND 8 CANNULAS WERE OPENED OUT OF THE 10 CONTAINED IN A BOX, AND ALL HAD THE SAME DEFECT. THE SURGEON HAD TO CHANGE THE BATCH NUMBER (NOT COMMUNICATED) IN ORDER TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES FOR THE CHILD, AND NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20345708 ↗

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-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