DLP® 12116Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20643169086719), received between Feb 18, 2021 and Jun 18, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 reports).

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

1 other recall cover devices cleared under the same FDA submission (K834352); 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 24, 2021Open, Classified

   Potential for a wire protrusion through the left heart vent catheter tip

   Z-2504-2021 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2025Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A 12116 DLP LEFT HEART VENT CATHETER, THE CUSTOMER REPORTED THAT THE WIRE OF THE CANNULA HITS THE TIP OF IT AND WAS PROTRUDING. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22284629 ↗
• MalfunctionJul 14, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A 12116 DLP LEFT HEART VENT CATHETER, IT WAS NOTED THAT THE WIRE OF THE CANNULA WAS PROTRUDING THROUGH THE CANNULA TIP. THE CANNULA WAS REPLACED TO COMPLETE THE PROCEDURE. THE CUSTOMER STATED THAT ALL OF THE OTHER CANNULAE IN THE PACK HAD THE SAME ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THIS ISSUE. ADDITIONAL INFORMATION RECEIVED: THE CUSTOMER HAS INDICATED THAT ANOTHER CANNULA LOT ALSO HAS THIS ISSUE. THE ISSUE WITH BOTH LOTS WERE NOTED AT THE SAME TIME. ALL OF THE CANNULA FOR EACH EFFECTED LOT HAD THE SAME ISSUE. ALL CANNULAE WILL BE RETURNED FOR ANALYSIS. THE CANNULA FROM LOT 2019081291 WAS USED DURING A PROCEDURE, BUT WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. THE BELOW QUANTITIES OF EACH LOT WILL BE RETURNED FOR ANALYSIS: (B)(4), ONE PACK OF 2019081291 (B)(4), ONE PACK OF 2020020093 (B)(4) OF 2019081291 (B)(4) OF 2020020093.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17323886 ↗
• MalfunctionJul 3, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A 12116 DLP LEFT HEART VENT CATHETER, IT WAS NOTED THAT THE WIRE OF THE CANNULA WAS PROTRUDING THROUGH THE CANNULA TIP. THE CANNULA WAS REPLACED TO COMPLETE THE PROCEDURE. THE CUSTOMER STATED THAT ALL OF THE OTHER CANNULAE IN THE PACK HAD THE SAME ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THIS ISSUE. ADDITIONAL INFORMATION RECEIVED: THE CUSTOMER HAS INDICATED THAT ANOTHER CANNULA LOT ALSO HAS THIS ISSUE. THE ISSUE WITH BOTH LOTS WERE NOTED AT THE SAME TIME. ALL OF THE CANNULA FOR EACH EFFECTED LOT HAD THE SAME ISSUE. ALL CANNULAE WILL BE RETURNED FOR ANALYSIS. THE CANNULA WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17246166 ↗
• MalfunctionAug 10, 2021Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE, THE CUSTOMER REPORTED THE LEFT HEART VENT CATHETER WAS BENT. THERE WAS NO IMPACT ON THE FLOW DUE TO THE BEND. THE DEVICE WAS REPLACED. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12302319 ↗
• MalfunctionAug 10, 2021Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT POST OPERATIVELY THE CUSTOMER NOTED THAT WHEN THE SUCTION VENT CANNULA WAS REMOVED FROM THE PATIENT, WIRE WAS PROTRUDING FROM THE TIP. THE DEVICE HAD BEEN USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12301570 ↗
• MalfunctionMay 6, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING USE UPON REMOVAL OF THE DLP LEFT HEART VENT CATHETER, THE CUSTOMER REPORTED THE INTRODUCER WAS EXTRUDING FROM THE TIP OF THE DEVICE. THE DEVICE HAD BEEN USED TO COMPLETE THE CASE. THERE WAS NO PATIENT IMPACT OR EFFECT ON THE COURSE OF THE PROCEDURE. NOTHING UNUSUAL WAS NOTED DURING DEVICE INSPECTION PRIOR TO USE. THE DEVICE WAS NOT MANIPULATED EXCESSIVELY IN ANY WAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11783667 ↗
• InjuryApr 14, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE, THE CUSTOMER REPORTED THE WIRE OF THE DLP LEFT HEART VENT CATHETER EXTRUDED AND MADE A SMALL HOLE INTO THE PATIENT'S VENTRICLE. SEE ATTACHED IMAGE OF DEVICE. THE HOLE WAS CLOSED WITH A PATCH. PATIENT SURVIVED WITH NO FURTHER COMPLICATIONS.

  Patient problems: Laceration(s)

  MAUDE report 11663451 ↗
• InjuryFeb 18, 2021Material Separation; Material Deformation; Material Separation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE, THE CUSTOMER REPORTED ON 2ND JANUARY 2021 IN THE VASCULAR SURGERY BLOCK, THE CARE TEAM ENCOUNTERED A PROBLEM WHEN THE LEFT HEART VENT CANNULA WAS REMOVED. THEY HAD A LOT OF TROUBLE PUTTING THE CANNULA IN, AND ON REMOVAL THEY FOUND THAT THE RIGID METAL BAND HAD COME OUT OF ITS PLASTIC SHEATH AND WAS MOST LIKELY THE CAUSE OF A WOUND TO THE PATIENT'S LEFT ATRIUM. THE DEVICE WAS USED TO COMPLETE THE CASE. PATIENT STATUS FOLLOWING THE CASE WAS DESCRIBED AS: ALIVE - NO INJURY. ADDITIONAL INFORMATION RECEIVED - THE SURGEON HAD TO MAKE A SUTURE ON THE LEFT ATRIUM TO STOP THE BLEEDING. IT WAS CONFIRMED THAT NOTHING CAME OFF THE CANNULA.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11342017 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K834352. One submission often covers many models, so check the product and lot details in each record.

• Z-2505-2021 · Aug 24, 2021 · Open, Classified
  DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only