Tego™ D1000Recalls & reported problems

Summary

The FDA's MAUDE database contains 655 adverse event reports that list this exact device (DI 00840619026059), received between Jul 31, 2017 and Sep 10, 2026 — classified as 2 deaths, 15 injuries, 638 malfunctions.

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

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

1 other recall cover devices cleared under the same FDA submission (K053106); 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. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 655 reports, 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 ↗
• MalfunctionMar 9, 2026No Flow

  THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING AN UNSPECIFIED TEGO CONNECTOR. IT WAS REPORTED THAT THE CUSTOMER WAS UNABLE TO CORRECTLY ATTACH LINE SAFETY CLIP WHILE TEGO WAS IN PLACE (CVC CONNECTION BENDS). IT WAS ALSO STATED THAT TEGO HAS CLOTTED AND REQUIRED EXTRA CHANGES. THE EVENT OCCURRED DURING PATIENT USE. THERE WAS PATIENT INVOLVEMENT; NO PATIENT HARM, BUT DELAY IN TREATMENT WAS CAUSED BY THE EXTRA TIME IN DIAGNOSING THE ISSUE, THEN CHANGING THE CAPS IS THE ONLY REAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24549684 ↗
• MalfunctionMar 5, 2026Tear, Rip or Hole in Device Packaging; Air/Gas in Device

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A TEGO¿ CONNECTOR WHERE THE CUSTOMER REPORTED THAT AS THE PLUNGER WAS PULLED BACK, THE ENTIRE SYRINGE RELEASED FROM THE END OF THE CONNECTOR CAP, AND AIR BEGAN TO BE SUCKED INTO THE EXPOSED LUMEN. THE CLAMP WAS IMMEDIATELY CLOSED. UPON INSPECTION, THE CUSTOMER STATED THAT THE RUBBERIZED COATING ON THE TEGO CONNECTOR CAP HAD TORN AND THE SEAL INSIDE THE END OF THE CAP PULLED OUT RESULTING IN THE SYRINGE SLIDING OFF AND AIR EXPOSURE. THE HOME HEMODIALYSIS (HHD) REGISTERED NURSE (RN) WAS IMMEDIATELY NOTIFIED. APPROXIMATELY 0.5ML OF AIR AND 5ML OLD BLOOD REMOVED FROM LUMEN WITH FRESH 10ML SYRINGE WITHOUT RESISTANCE. THERE WAS PATIENT INVOLVEMENT BUR HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519764 ↗
• MalfunctionMar 4, 2026No Flow

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A TEGO CONNECTOR WHERE THE CUSTOMER REPORTED THAT THEY HAD DIFFICULTY WITH ASPIRATION OF THE VENOUS LUMEN; THERE WAS NO BLOOD COMING OUT DURING CENTRAL VENOUS CATHETER CARE. 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 24513806 ↗
• MalfunctionMar 3, 2026Air/Gas in Device

  AN EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVED A TEGO CONNECTOR WHERE IT WAS REPORTED THAT THE PRODUCT SEEMS TO BE GETTING MORE AIR INTO THE CIRCUIT. ONCE THEY TAKE OFF THE BUNGS, THE PROBLEM IS RESOLVED COMPLETELY. THE PATIENTS HAVE BEEN ADVISED BY THEIR HEALTH CARE PROFESSIONAL TO NOT USE THESE BUNGS AND ONLY USE WHITE CAPS AT THE END OF TREATMENT. THE PATIENT DOES NOT HAVE ANY ILL EFFECTS OR HOSPITALIZATION, AS A DIRECT RESULT OF THIS. BUT ONE OF THE PATIENTS IS IN HOSPITAL DUE TO CENTRAL LINE ISSUES. THERE WERE PATIENT INVOLVEMENT AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24494340 ↗
• MalfunctionMar 3, 2026Air/Gas in Device

  AN EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVED A TEGO CONNECTOR WHERE IT WAS REPORTED THAT THE PRODUCT SEEMS TO BE GETTING MORE AIR INTO THE CIRCUIT. ONCE THEY TAKE OFF THE BUNGS, THE PROBLEM IS RESOLVED COMPLETELY. THE PATIENT HAS BEEN ADVISED BY THEIR HEALTH CARE PROFESSIONAL TO NOT USE THESE BUNGS AND ONLY USE WHITE CAPS AT THE END OF TREATMENT. THERE WERE PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24494315 ↗
• MalfunctionFeb 27, 2026Air/Gas in Device

  AN EVENT INVOLVED A TEGO CONNECTOR; REPORTED THAT AIR WAS DETECTED 2 HOURS INTO THE RUN. AIR WAS SEEN FROM THE TEGO OR CATHETER LUMEN ALONG THE ARTERIAL DIALYSIS LINE. THERE WAS PATIENT INVOLVEMENT, BUT UNKNOWN DELAY IN THERAPY AND NO DEATH OR SERIOUS DETERIORATION OF A PERSON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24467933 ↗
• MalfunctionFeb 27, 2026Material Separation

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN (B)(6) 2025 AND INVOLVED A TEGO CONNECTOR. IT WAS REPORTED THAT TEGO DID NOT HAVE A PROPER CONNECTION, AND THAT THEY SHUTTERED, BEARING THE DANGER THAT THESE SHUTTERED PARTS COULD ENTER THE PATIENT'S BLOOD STREAM. THE RUBBER PART WAS CUT OFF THE PRODUCT DURING PRIMING AND INFUSION. THERE WAS AN INVOLVED PATIENT THAT WAS UNAWARE OF THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24466620 ↗
• MalfunctionFeb 25, 2026No Flow

  EVENT OCCURRED REGARDING A TEGO CONNECTOR F/CATHETER WHERE IT WAS REPORTED THAT DEVICE PLUGS UP WHENEVER PATIENT TRIES TO USE IT AND DOES NOT WANT TO USE IT ANYMORE. THERE WERE PATIENT INVOLVEMENT AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24443349 ↗
• MalfunctionFeb 18, 2026Fluid/Blood Leak

  ADDITIONAL INFORMATION: THE PRODUCT WAS KEPT IN ITS ORIGINAL PACKAGING IN THE FACILITY'S WAREHOUSE.

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

  MAUDE report 24378795 ↗
• InjuryFeb 16, 2026No Flow

  A EVENT WAS RECEIVED REGARDING A TEGO® CONNECTOR IN WHICH IT WAS REPORTED THAT THEY HAD DIFFICULTY MAINTAINING BLOOD FLOW AT ONSET OF TREATMENT, AND THE PATIENT DEVELOPED AN INFECTION. FOLLOWING TROUBLESHOOTING FOUND NO FURTHER ISSUE WITH BLOOD FLOW ONCE TEGO CAP REMOVED FROM CATHETER. NEW TEGO PLACED ON CATHETER AT END OF TREATMENT. HOME HEMO PATIENT RECEIVING TREATMENTS AT THE DIALYSIS FACILITY. THERE WAS NO MEDICATION ADMINISTERED, ONLY HEMODIALYSIS TREATMENT. IT WAS INFUSED VIA CENTRAL LINE CATHETER. IV ANTIBIOTICS ADMINISTERED AFTER BLOOD CULTURES OBTAINED. PATIENT HOSPITALIZED ON (B)(6) 2025 FOR CARDIAC WORKUP TO RULE OUT ENDOCARDITIS PATIENT RECEIVED 6 WEEKS OF IV ANTIBIOTICS AND HAS NOW RECOVERED. NO DEFECT OBSERVED ON TEGO. CATHETER REPLACED. THE PATIENT RECEIVED FULL HEMODIALYSIS TREATMENT ONCE THE TEGO CONNECTOR WAS REMOVED. BACTEREMIA RESOLVED FOLLOWING COURSE OF IV ANTIBIOTICS. THERE WAS NO DELAY IN TREATMENT.

  Patient problems: Bacterial Infection

  MAUDE report 24345505 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K053106. One submission often covers many models, so check the product and lot details in each record.

• Z-0988-2017 · Aug 24, 2016 · Terminated
  Tego Connector, Item No. D1000, NM1000 The Tego Needle Free Access Device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an