Tablo(R) Cartridge PN-0008544Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850001011273), received between Oct 15, 2024 and Oct 28, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS AIR IN LINE AND BLOOD LEAK DURING TREATMENT. TREATMENT WAS DISCONTINUED, RESULTING IN THE LOSS OF TWO FULL CIRCUITS OF BLOOD. A THIRD CARTRIDGE FROM A DIFFERENT LOT NUMBER WAS USED WITH NO ISSUES OBSERVED. THE PATIENT SUBSEQUENTLY RECEIVED A DOUBLE DOSE OF EPOGEN THE FOLLOWING WEEK PER PHYSICIAN DIRECTION, THEN RESUMED THE NORMAL DOSE AFTER HEMOGLOBIN DROPPED BY ONE POINT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23403978 ↗
• MalfunctionOct 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE ARE HOSPITAL UTILIZATION OF TABLO DIALYSIS MACHINES AND BLOOD LINES FROM LOT NUMBERS WITH KNOWN PROBLEMS. USE OF THESE PRODUCTS AND EQUIPMENT IS EXPOSING CRITICALLY-ILL PATIENTS TO UNNECESSARILY HAZARDOUS CONDITIONS INVOLVING RISK OF SIGNIFICANT BLOOD LOSS, HEMOLYSIS, AIR EMBOLISM, AND SYSTEMIC INFECTION. FAULTY BLOOD LOT LINES ARE CAUSING BLOOD LEAKS INTERNALLY AND EXTERNALLY. INTERNAL BLOOD LEAKS ARE NEARLY UNDETECTABLE, LEADING TO AN UNKNOWN LEVEL OF CONTAMINATION. SINCE MACHINES ARE NOT PATIENT-SPECIFIC, INDIVIDUAL PATIENT EXPOSURE TO POTENTIAL BLOOD BORNE PATHOGENS, SUCH AS HEPATITIS B, IS INCREASED. HOSPITAL USE OF EXPIRED ACID BATHS FOR DIALYSIS TREATMENTS AND SHARING OF SINGLE-USE DIALYSATE BATHS BETWEEN MULTIPLE PATIENTS WHEN STOCK IS LOW.

  Patient problems: Insufficient Information

  MAUDE report 20457720 ↗