TegoRecalls & reported problems across all models

We found 2 models of Tego by Icu Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 686 adverse event reports in the FDA's MAUDE database, received between Jul 31, 2017 and Sep 10, 2026 — classified as 2 deaths, 16 injuries, 668 malfunctions.

The most frequently reported specific device problem is “No Flow” (179 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Tego recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Dec 19, 2025Open, Classified

   Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear; may result in fluid leaks, occluded fluid flow, inability to inject/withdraw blood product, delayed/interrupted therapy, exposure to biological contaminants, air infused into the body

   Z-1111-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported Tego problems

Tego models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Tego™ D1000

  Set, administration, intravascular
  1 recall2 deaths655 reports
• Tego™ D1005

  Set, administration, intravascular
  31 reports

Recent Tego adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Degraded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722698 ↗
• MalfunctionSep 9, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50698734 ↗
• MalfunctionSep 7, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50653102 ↗
• MalfunctionAug 31, 2026Fluid/Blood Leak

  Additional used device has been received for the investigation and a reported incident involving a Tego Connector was associated with blockages and leaks. No patient harm or injuries were reported as a result of the event, and there was no delay in therapy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50524488 ↗
• MalfunctionAug 31, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50522528 ↗
• MalfunctionAug 11, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209191 ↗
• MalfunctionJun 16, 2026Degraded

  THE EVENT INVOLVED A TEGO, AND IT WAS REPORTED THAT SHEARING OF SILICONE SHEATH WAS NOTED. THERE WAS PATIENT INVOLVEMENT, THERE WAS NO DELAY IN THERAPY, NO ONE WAS HARMED AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25516917 ↗
• MalfunctionJun 16, 2026Degraded

  THE EVENT INVOLVED A TEGO, AND IT WAS REPORTED THAT SHEARING OF SILICONE SHEATH WAS NOTED. THERE WAS PATIENT INVOLVEMENT, THERE WAS NO DELAY IN THERAPY, NO ONE WAS HARMED AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25516910 ↗
• MalfunctionJun 10, 2026Disconnection; No Flow

  AN EVENT INVOLVING A TEGO CONNECTOR WAS REPORTED THAT WHILE ATTEMPTING TO DRAW LABORATORY SAMPLES, BLOOD FLOW COULD NOT BE ACHIEVED. UPON REMOVAL OF THE VACUTAINER, THE SILICONE COMPONENT OF THE TEGO WAS OBSERVED TO BE LOOSE, SO TEGO WAS REPLACED. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25455743 ↗
• MalfunctionMay 29, 2026Fluid/Blood Leak

  A TEGO® CONNECTOR REPORTEDLY "POPPED OFF" OF 5 ML AND 20ML SYRINGES AND THIS CAUSED BLOOD TO SPILL DURING A PATIENT'S HEMODIALYSIS PROCEDURE. THE CUSTOMER ALSO STATED THAT THIS ISSUE GENERALLY CAUSED DISRUPTION (POSSIBLY A DELAY) TO HEMODIALYSIS PROCEDURES. NO HARM OCCURRED AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25336883 ↗
• MalfunctionMay 28, 2026Complete Blockage; No Flow

  ON AN UNSPECIFIED DATE, A TEGO® CONNECTOR WAS REPORTEDLY UNABLE TO ASPIRATE THROUGH THE DEVICE THAT WAS IN USE WITH PATIENTS IN THE TRAINING ROOM FOR HOME HEMODIALYSIS TRAINING. THEY HAD TO REMOVE THE TEGO'S TO ASPIRATE BLOOD FROM THE CENTRAL VENOUS CATHETER (CVC) LIMBS, MOST OF THE TIME DUE TO A LONG STRINGY BLOOD CLOT BUT SOMETIMES THAT WASN'T THE CASE. THEY ARE HAVING TO CHANGE OUT THE TEGOS APPROXIMATELY 3X WEEK DUE TO THIS ISSUE. THEY HAVE STARTED TO INSTILL HEPARIN IN THE DWELLS, SO THEY WILL SEE IF THAT HELPS. THERE WAS PATIENT INVOLVEMENT WITH NO HARM. THIS EMDR REFLECTS 2 SIMILAR OCCURRENCES/EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25323078 ↗
• MalfunctionMay 20, 2026Fluid/Blood Leak

  EVENT OCCURRED REGARDING A TEGO CONNECTOR WHERE THE REPORTER REPORTED THAT, "DURING THE BEGINNING OF A DIALYSIS SESSION, AND IN SOME CASES DURING THE ENDING OF THE DIALYSIS SESSION, A LEAKAGE (BACKFLOW) FROM THE TEGO VALVES WAS OBSERVED. THEY CHANGED THE TEGO VALVES OF THE CUSTOMER WITH NEW ONES, BUT THE PROBLEM PERSISTED. THE DATE OF THE EVENT WAS ON (B)(6) 2026 UNTIL(B)(6) 2026, AND FROM (B)(6) 2026 UNTIL (B)(6) 2026. THIS WAS IDENTIFIED IN FIVE (5) DIFFERENT CASES (PATIENTS). NO EASILY IDENTIFIABLE CUTS OR HOLES OR OTHER IMPERFECTIONS WERE NOTICED ON THE PRODUCT. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25229656 ↗
• MalfunctionMay 15, 2026No Flow; Material Split, Cut or Torn

  AN EMAIL WITH ATTACHED MEDWATCH MW5186281 WAS RECEIVED ON BEHALF OF A CUSTOMER FACILITY REGARDING A TEGO CONNECTOR IN WHICH IT WAS REPORTED BY A REGISTERED NURSE THAT A TEGO CAP USED ON ARTERIAL/VENOUS LUMEN HAD BLOOD CLOT ON THE INSIDE OF THE TEGO CONNECTOR AND REGISTERED NURSE NOTED THAT THERE WAS ALSO SOME TEARING TO THE SILICON SEAL AS WELL. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25194510 ↗
• MalfunctionMar 16, 2026Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN FEBRUARY 2026 AND INVOLVED A TEGO¿ CONNECTOR. IT IS UNCLEAR IF THE CENTRAL VENOUS ACCESS DEVICE (CVAD) WAS CLAMPED AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE SEPTUM APPEARED TO BE DOMED/PROTRUDING OUTWARD. THE EVENT OCCURRED DURING PATIENT USE WHEN A NEW TEGO WAS CHANGED PRIOR TO COMMENCEMENT OF HEMODIALYSIS (HD). THE SET WAS REPLACED AND THERAPY RESUMED WITHOUT ANY PROBLEM. THERE WAS NO IV SOLUTION OR MEDICATION USED. THERE WAS PATIENT INVOLVEMENT, BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24611326 ↗
• MalfunctionMar 9, 2026No Flow

  THE EVENT INVOLVED A TEGO® CONNECTOR. IT WAS REPORTED THAT IT DID NOT PERFORM RINSE BACK AS TEGO CAPS DID NOT ALLOW BLOOD TO FLOW FROM THE VENUS LINE. THERE WAS PATIENT INVOLVEMENT. NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24550811 ↗

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