Cleo 21-7221-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 30610586028346), received between Mar 20, 2017 and Apr 16, 2026 — classified as 1 death, 28 injuries, 98 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (35 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 127 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKAGE OCCURRED DURING USE AT THE ABDOMEN INSERTION SITE. THE LEAKAGE WAS REPORTED ON THE CANNULA SIDE AT THE CLIP (TUBING) CONNECTION, OCCURRING AFTER A FEW MINUTES TO HOURS FOLLOWING PLACEMENT. A TOTAL OF THREE DEVICES WERE INVOLVED, WITH 2 DIFFERENT LOT NUMBERS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24897219 ↗
• MalfunctionMar 18, 2026Obstruction of Flow

  IT WAS REPORTED THAT, IN LESS THAN AN HOUR, AN OCCLUSION ALARM, BLOCKED FLOW OCCURRED. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED. THIS REPORT CAPTURES TWO OF FOUR OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24630391 ↗
• MalfunctionMar 18, 2026Obstruction of Flow

  IT WAS REPORTED THAT, IN LESS THAN AN HOUR, AN OCCLUSION ALARM, BLOCKED FLOW OCCURRED. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED. THIS REPORT CAPTURES FOUR OF FOUR OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24628308 ↗
• MalfunctionMar 18, 2026Obstruction of Flow

  IT WAS REPORTED THAT, IN LESS THAN AN HOUR, AN OCCLUSION ALARM, BLOCKED FLOW OCCURRED. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED. THIS REPORT CAPTURES THREE OF FOUR OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24628306 ↗
• MalfunctionMar 18, 2026Obstruction of Flow

  IT WAS REPORTED THAT, IN LESS THAN AN HOUR, AN OCCLUSION ALARM, BLOCKED FLOW OCCURRED. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED. THIS REPORT CAPTURES ONE OF FOUR OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24628303 ↗
• MalfunctionMar 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT, DURING USE OF THE PRODUCT, A LEAK FROM THE SIDE CANNULA TO THE INSERTION POINT WAS OBSERVED. THERE WAS PATIENT INVOLVEMENT. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521990 ↗
• MalfunctionMar 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT, DURING USE OF THE PRODUCT, A LEAK FROM THE SIDE CANNULA TO THE INSERTION POINT WAS OBSERVED. THERE WAS PATIENT INVOLVEMENT. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521985 ↗
• MalfunctionMar 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT, DURING USE OF THE PRODUCT, A LEAK FROM THE SIDE CANNULA TO THE INSERTION POINT WAS OBSERVED. THERE WAS PATIENT INVOLVEMENT. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521970 ↗
• MalfunctionMar 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT, DURING USE OF THE PRODUCT, A LEAK FROM THE SIDE CANNULA TO THE INSERTION POINT WAS OBSERVED. THERE WAS PATIENT INVOLVEMENT. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521966 ↗
• MalfunctionMar 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT, DURING USE OF THE PRODUCT, A LEAK FROM THE SIDE CANNULA TO THE INSERTION POINT WAS OBSERVED. THERE WAS PATIENT INVOLVEMENT. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521840 ↗
• MalfunctionMar 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT, DURING USE OF THE PRODUCT, A LEAK FROM THE SIDE CANNULA TO THE INSERTION POINT WAS OBSERVED. THERE WAS PATIENT INVOLVEMENT. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521811 ↗
• MalfunctionMar 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT, DURING USE OF THE PRODUCT, A LEAK FROM THE SIDE CANNULA TO THE INSERTION POINT WAS OBSERVED. THERE WAS PATIENT INVOLVEMENT. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521670 ↗
• MalfunctionMar 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT, DURING USE OF THE PRODUCT, A LEAK FROM THE SIDE CANNULA TO THE INSERTION POINT WAS OBSERVED. THERE WAS PATIENT INVOLVEMENT. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521663 ↗
• MalfunctionMar 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT, DURING USE OF THE PRODUCT, A LEAK FROM THE SIDE CANNULA TO THE INSERTION POINT WAS OBSERVED. THERE WAS PATIENT INVOLVEMENT. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521650 ↗
• MalfunctionMar 3, 2026Break

  IT WAS REPORTED THAT THE CLEO CATHETER TIP HAD BEEN FOUND BROKEN OFF FROM THE PATIENT'S TWO MOST RECENT SITE AND THE LOCATION OF THE LODGED FRAGMENT HAD REMAINED UNKNOWN. THEY HAD BELIEVED THE ISSUE TO BE A DEFECT ASSOCIATED WITH CLEO LOT (EXPIRATION DATE UNKNOWN). THEY HAD STATED THAT THE PATIENT HAD BEEN SEEN BY THE PHYSICIAN AFTER THE FIRST OCCURRENCE AND HAD FOLLOWED UP ACCORDINGLY. THE FATHER HAD FURTHER REPORTED THAT THE PHYSICIAN HAD ADVISED MONITORING THE SITE FOR REDNESS, ITCHING, OR INFECTION, AND THAT AN ULTRASOUND MIGHT BE REQUIRED. THE FATHER HAD DECLINED THE ULTRASOUND, ELECTING INSTEAD TO WAIT, AND HAD STATED THAT THE AREA APPEARED HEALED. THEY HAD ALSO REPORTED THAT THE AREA BENEATH THE CATHETER SITE HAD FELT SOMEWHAT FIRM BUT OTHERWISE NORMAL. THE REGISTERED PHARMACIST (RPH) HAD ADVISED THE FATHER TO FOLLOW UP WITH THE PHYSICIAN¿S OFFICE REGARDING AN ULTRASOUND, AND A CLINICAL NURSE SPECIALIST (CNS) HAD BEEN ASSIGNED TO REVIEW THE DETAILS. THE RPH HAD ALSO INSTRUCTED THE FATHER TO CALL 911 IF THE ISSUE WERE TO RECUR. THE PATIENT¿S CURRENT REMODULIN DOSE HAD BEEN 100 NG PER KG PER MIN SUBCUTANEOUSLY. THE PATIENT HAD BEEN SELF-FILLING REMUNITY VIA THE REMUNITY PUMP A

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24500727 ↗
• MalfunctionMar 2, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT, DURING USE OF THE PRODUCT, A LEAK FROM THE SIDE CANNULA TO THE INSERTION POINT WAS OBSERVED. THERE WAS PATIENT INVOLVEMENT. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482279 ↗
• MalfunctionJul 23, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS A LEAK ON THE CANNULA SIDE. THE PROBLEM OCCURRED DURING INFUSION WHILE THE CATHETER WAS IN USE. THE SITE OF PLACEMENT OF THE CATHETER WAS THE ARM. THERE WAS PATIENT INVOLVEMENT, AND NO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576396 ↗
• MalfunctionJul 23, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS A LEAK ON THE CANNULA SIDE. THE PROBLEM OCCURRED DURING INFUSION WHILE THE CATHETER WAS IN USE. THE SITE OF PLACEMENT OF THE CATHETER WAS THE ARM. THERE WAS PATIENT INVOLVEMENT, AND NO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576328 ↗
• MalfunctionJul 23, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS A LEAK ON THE CANNULA SIDE. THE PROBLEM OCCURRED DURING INFUSION WHILE THE CATHETER WAS IN USE. THE SITE OF PLACEMENT OF THE CATHETER WAS THE ARM. THERE WAS PATIENT INVOLVEMENT, AND NO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576319 ↗
• MalfunctionJul 23, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS A LEAK ON THE CANNULA SIDE. THE PROBLEM OCCURRED DURING INFUSION WHILE THE CATHETER WAS IN USE. THE SITE OF PLACEMENT OF THE CATHETER WAS THE ARM. THERE WAS PATIENT INVOLVEMENT, AND NO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576318 ↗
• MalfunctionJul 23, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS A LEAK ON THE CANNULA SIDE. THE PROBLEM OCCURRED DURING INFUSION WHILE THE CATHETER WAS IN USE. THE SITE OF PLACEMENT OF THE CATHETER WAS THE ARM. THERE WAS PATIENT INVOLVEMENT, AND NO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576310 ↗
• MalfunctionJul 23, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS A LEAK ON THE CANNULA SIDE. THE PROBLEM OCCURRED DURING INFUSION WHILE THE CATHETER WAS IN USE. THE SITE OF PLACEMENT OF THE CATHETER WAS THE ARM. THERE WAS PATIENT INVOLVEMENT, AND NO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576203 ↗
• MalfunctionNov 22, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT AN OCCLUSION OCCURRED IN THE INFUSION SYSTEM DURING USE WITH THE PATIENT. PER THE REPORTER, THERE WERE NO PATIENT ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18193475 ↗
• MalfunctionNov 22, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT AN OCCLUSION OCCURRED IN THE INFUSION SYSTEM DURING USE WITH THE PATIENT. PER THE REPORTER, THERE WERE NO PATIENT ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18193470 ↗
• MalfunctionNov 22, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT AN OCCLUSION OCCURRED IN THE INFUSION SYSTEM DURING USE WITH THE PATIENT. PER THE REPORTER, THERE WERE NO PATIENT ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18193397 ↗