Level 1 DI-60HLRecalls & reported problems

Summary

The FDA's MAUDE database contains 150 adverse event reports that list this exact device (DI 20695085406010), received between Nov 1, 2019 and Apr 8, 2026 — classified as 1 death, 149 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (72 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 150 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Fluid/Blood Leak

  IT WAS STATED IN THE REPORT THAT THE CHEMICAL LEAKAGE OCCURRED DURING PRIMING. THE EVENT OCCURRED IN JULY-2024. THE ACTUAL ITEM IS AVAILABLE FOR INVESTIGATION. THIS OCCURRED BEFORE PATIENT USE/DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24817721 ↗
• MalfunctionFeb 11, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE LEAKAGE FROM THE FILTER WAS CONFIRMED DURING PATIENT USE. THE EVENT OCCURRED DURING PATIENT USE/ADMINISTRATION AT FACILITY. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24316931 ↗
• MalfunctionNov 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE EXHIBITED A HOLE NEAR THE LOWER CLAMP THAT CAUSED TRANSFUSION TO SPRAY OUT OF THE HOLE. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535770 ↗
• MalfunctionAug 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS STATED THAT THE LIQUID WAS LEAKING, FROM ALUMINUM PART. THE EVENT OCCURRED DURING PATIENT USE/ADMINISTRATION AT FACILITY. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22816130 ↗
• MalfunctionAug 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER RETURNED THE DEVICE FOR "LEAKAGE OF WATER FROM THE CIRCUIT," DURING DEVICE ANALYSIS, IT WAS FOUND THAT THE DEVICE WAS LEAKING FROM THE INFUSATE TUBING OUTLET AT THE BOTTOM OF THE HEAT EXCHANGER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737240 ↗
• MalfunctionJul 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE EXHIBITED LEAKAGE FROM THE TUBE CONNECTION. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22511306 ↗
• MalfunctionJun 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER RETURNED THE PRODUCT FOR WATER IS LEAKING FROM THE ALUMINUM CONNECTION, DURING DEVICE EVALUATION, IT WAS DETERMINED THAT A LEAK WAS OBSERVED AT THE INFUSATE TUBING OUTLET AT THE BOTTOM OF THE HEAT EXCHANGER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22302903 ↗
• MalfunctionJun 9, 2025Fluid/Blood Leak; Device Ingredient or Reagent Problem; Fluid/Blood Leak; Device Ingredient or Reagent Problem

  IT WAS STATED THAT LIQUID LEAKAGE WAS OBSERVED DURING THE CIRCULATING. THE EVENT OCCURRED BEFORE PATIENT USE/DURING PRIMING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22170982 ↗
• MalfunctionMay 1, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE DEVICE HAD A LEAKAGE FOUND IN THE TUBE. THE EVENT OCCURRED BEFORE OPENING/DURING OPENING/DURING UNPACKING AT FACILITY. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942438 ↗
• MalfunctionMar 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKAGE WAS FOUND ON BLUE D-60 MANIFOLD AT THE BEGINNING OF USE. THE PROBLEM WAS RESOLVED BY REPLACING WITH A NEW SET. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT THE HOSPITAL. THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21679472 ↗
• MalfunctionDec 9, 2024Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS LEAKAGE FOUND ON THE TUBING SYSTEM AT THE BEGINNING OF USE (LESS THAN 3 MINUTES). THEN THE TUBE DETACHED FROM THE OUTER WHITE TUBE. THIS PROBLEM WAS RESOLVED BY REPLACING WITH A NEW SET. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878893 ↗
• MalfunctionDec 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WATER LEAKS FROM THE CIRCUIT. THE EVENT OCCURRED DURING PRIMING AT THE FACILITY; NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20865561 ↗
• MalfunctionSep 17, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKAGE OCCURRED DURING PRIMING. THIS OCCURRED BEFORE PATIENT USE/DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237584 ↗
• MalfunctionAug 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WITH THE DEVICE THE PART WHERE THE GAS-VENT FILTER AND THE BLOOD TRANSFUSION ROUTE (A TUBING) WERE CONNECTED WAS LEAKING. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20033058 ↗
• MalfunctionAug 8, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LIQUID LEAKED FROM THE GRAY TIP. THIS OCCURRED DURING PATIENT USE/ADMINISTRATION. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939476 ↗
• MalfunctionJul 17, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE DEVICE WAS TRANSFUSING BLOOD TO THE PATIENT, BLOOD WAS LEAKING OUT FROM THE CONNECTION OF THE UPPER TUBE THAT IS COMING OUT OF THE SIDE OF THE FILTER WITH THE GAS VENT IN THE CIRCUIT. THE CIRCUIT WAS CHANGED OUT WITH A NEW ONE AND THEN IT WORKED FINE. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19766863 ↗
• MalfunctionJul 2, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PRIMING THE DEVICE WAS LEAKING MEDICAL SOLUTION FROM THE GRAY TIP. NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19656843 ↗
• MalfunctionJun 27, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BLOOD LEAKED FROM THE CONNECTION OF THE FLOW ROUTE IN THE DIRECTION OF THE AIR FILTER. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19626123 ↗
• MalfunctionMay 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A CIRCULATING WATER LEAK. THIS OCCURRED BEFORE PATIENT USE/DURING PRIMING AT FACILITY. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19363866 ↗
• MalfunctionMay 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE PRODUCT WAS USED, BLOOD LEAKAGE FROM THE CIRCUIT WAS CONFIRMED. ADVERSE PATIENT EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19351926 ↗
• MalfunctionApr 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE LEAKED FLUID ONTO THE FLOOR. THE TUBING WAS CUT OFF DURING THE PROCESS BECAUSE IT WAS CONSIDERED DANGEROUS. THIS OCCURRED DURING INFUSION. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19181222 ↗
• MalfunctionApr 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CHEMICAL SOLUTION LEAKED WHEN USING THE PRODUCT. THE EVENT OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19087605 ↗
• MalfunctionApr 2, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT "WHEN THE PRODUCT WAS USED, IT WAS OBSERVED THAT IT WAS DIFFICULT TO PASS THE INFUSION SOLUTION." THE EVENT OCCURRED IN LATE FEB-2024. THIS OCCURRED DURING PATIENT USE. NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19020851 ↗
• MalfunctionMar 27, 2024Break; Separation Problem; Break; Separation Problem

  IT WAS REPORTED THAT AFTER PRIMING, THE FIRST RBC (BLOOD PRODUCT) WAS ADMINISTERED UNDER PRESSURE, AND WHILE CONNECTING THE SECOND RBC TO THE SPIKE OF THE CIRCUIT, THE OPERATORS HAND SLIPPED AND SEPARATED THE SPIKE NEEDLE WHILE IT WAS STILL CONNECTED TO THE RBC. IT IS THOUGHT THAT THE WEIGHT OF ONE RBC WAS APPLIED TO THE UPPER TIP OF THE DRIP CHAMBER, CAUSING IT TO BREAK AND BREAK OFF. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18987896 ↗
• MalfunctionJan 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BLOOD FOR A TRANSFUSION LEAKED. THE LEAK APPEARED TO HAVE COME FROM AROUND THE JOINT BETWEEN THE FILTER BODY WITH THE GAS VENT AND THE TUBE. AFTER THAT, A NEW TUBE WAS USED AND THERE WAS NO PROBLEM. THIS OCCURRED DURING PATIENT USE. NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18458246 ↗