Tablo(R) Cartridge PN-0005643Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00850001011211), received between Oct 11, 2022 and Aug 11, 2023 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2023Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT THERE WAS ARTERIAL POD SEPARATION ONE HOUR AND 30 MINUTES INTO PATIENT TREATMENT ON TABLO AND NO ALARM OCCURRED BEFORE AND DURING THE INCIDENT. THERE WAS AN ESTIMATE OF 400 - 500 ML BLOOD LOSS. IT WAS NOTED THAT THE PATIENT IS FEELING SICK AND MAY NEED TRANSFUSION. NOTE: USER STATES THE PATIENT MAY NEED BLOOD TRANSFUSION; HOWEVER, THIS CANNOT BE CONFIRMED, OTHER THAN THAT PATIENT WAS NOTED AS IN STABLE CONDITION.

  Patient problems: Insufficient Information

  MAUDE report 17515604 ↗
• InjuryMar 7, 2023Fluid/Blood Leak; Loose or Intermittent Connection

  DURING DIALYSIS, BLOOD LEAKING ONTO FLOOR FROM TOP OF DIALYZER OF SLED MACHINE. CNC HAD FLUSHED THE SYSTEM WHEN THE TMP ROSE PRIOR TO THE BLOOD LEAK. HE ALSO TIGHTENED RED CONNECTOR TO DIALYZER WHILE RN WAS IN THE ROOM AND BLOOD LEAK STOPPED MOMENTARILY. AFTER A FEW MINUTES, YOU COULD SEE THE CONNECTION LOOSEN AND BLOOD LEAK RE-APPEARED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16504133 ↗
• InjuryMar 7, 2023Fluid/Blood Leak; Obstruction of Flow

  PATIENT ON SEDATION HOLIDAY AND SPONTANEOUS BREATHING TRIAL ON VENT RECEIVING DIALYSIS. HE HAD A STRONG COUGH AND THE SLED MACHINE CLOTTED AND LEAKED AT TOP OF FILTER. TREATMENT COMPLETED BASED ON THE TABLO HUB REPORT. IN INTENSIVE CARE UNIT END STAGE RENAL DISEASE, HYPERKALEMIA, TYPE 2 DIABETES MELLITUS; ASTHMA, DEPENDENCE ON RENAL DIALYSIS, OBESITY, NICOTINE DEPENDENCE.

  Patient problems: Cough

  MAUDE report 16504121 ↗
• MalfunctionOct 11, 2022Defective Alarm; Fluid/Blood Leak; Temperature Problem

  NEARING END OF SLED (SUSTAINED LOW-EFFICIENCY DIALYSIS) TREATMENT, TOP PORTION OF SLED DIALYZER LEAKED. APPROX 400CC BLOOD INTO THE FLOOR. SLED DID NOT ALARM. LURE LOCK WAS CHECKED AND SECURE, TREATMENT RESUMED AND FLUSH STARTED. TREATMENT CONTINUED FOR 10 MINUTES BEFORE THE TMP BECAME TOO HIGH AND FORCED TO STOP THE TREATMENT AND RETURN BLOOD 30 MINUTES EARLY. PT HAD BEEN GIVEN HEPARIN BOLUS VIA SLED FOR THIS TREATMENT. PT HAS BEEN ON SLED MULTIPLE TIMES NOW AND THE FILTER HAS CLOGGED/CLOTTED MULTIPLE TIMES PER TREATMENT. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15589112 ↗
• MalfunctionOct 11, 2022Disconnection; Fluid/Blood Leak

  SLED: COMPLETE DISCONNECTION BETWEEN RED (ACCESS LINE) AND THE DIALYZER/FILTER. BLOOD DRIPPING ONTO FLOOR. ACCESS ALARMS. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15588666 ↗