Cleo 21-7222-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 30610586028353), received between Jul 10, 2017 and May 9, 2024 — classified as 5 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (6 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2024Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE CATHETERS DIDN'T STICK TO THE SKIN DURING INSERTION. THIS OCCURRED WITH 3 - 4 CATHETERS. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281793 ↗
• MalfunctionMay 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT OBSERVED A LEAKAGE AT THE ADAPTER BETWEEN THE TUBING AND THE CATHETER, AFTER A FEW HOURS OF INSERTION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16913596 ↗
• MalfunctionMay 10, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE ADHESIVE BARELY OR DOES NOT ADHERE TO THE PATIENT'S SKIN. CATHETER NEEDS TO BE CHANGED ALMOST 4 TIMES A DAY. NO CLINICAL CONSEQUENCE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16903795 ↗
• MalfunctionMay 9, 2023Fluid/Blood Leak; Insufficient Flow or Under Infusion; Fluid/Blood Leak; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE DEVICE WAS LEAKING ON CATHETER CONNECTION AND MEDICATION WAS NOT BEING DELIVERED PROPERLY. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16894228 ↗
• MalfunctionMay 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT OBSERVED A LEAKAGE AT THE ADAPTER BETWEEN THE TUBING AND THE CATHETER, AFTER A FEW HOURS OF INSERTION. THERE WAS NO PATIENT, OR CLINICIAN INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16892591 ↗
• MalfunctionMay 8, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT THE CAP ON THE KIT IS CROOKED, SO INSULIN LEAKED OUT INSTEAD OF INTO THE SUBCUTANEOUS FAT TISSUE. THIS OCCURRED AT NIGHT AFTER THE USER HAD TO CHANGE A CATHETER DUE TO KINKING RESULTING IN HIGH BLOOD GLUCOSE, SO THIS SEVERE HYPERGLYCEMIA CONTINUED FOR SEVERAL HOURS. THE USER WAS ABLE TO CORRECT IT BUT STATED A LESS EXPERIENCED USER WOULD PROBABLY HAVE HAD TO GO TO A HOSPITAL OR EMERGENCY ROOM. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED.

  Patient problems: Hyperglycemia

  MAUDE report 16892125 ↗
• MalfunctionMay 8, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT THE CATHETER WAS KINKING. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16892046 ↗
• MalfunctionMay 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT CATHETER COULD NOT BE FIXED AND WAS PULLED OUT AGAIN WHEN THE INSERTER WAS DETACHED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16889939 ↗
• MalfunctionMay 8, 2023Leak/Splash; Patient Device Interaction Problem; Leak/Splash; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING INSERTION OF CATHETER, THE CANNULA DID NOT GO THROUGH THE SKIN AND THE NURSE DID NOT NOTICE AT THE MOMENT. THIS HAS HAPPENED ON SEVERAL OCCASIONS WITH EITHER LEAKAGE OR THE NEEDLE NOT RETRACTING, AND ANOTHER REPORT OF THE WHITE CAP OF THE CATHETER BEING BROKEN OFF. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16888877 ↗
• MalfunctionMay 8, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED, THAT 12 CATHETERS WERE NOT TOLERATED AND HAD TO BE REMOVED PREMATURELY. ALLERGIC REACTION / INFECTION OF THE SETTING SITE. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED.

  Patient problems: Local Reaction

  MAUDE report 16888236 ↗
• MalfunctionApr 14, 2023Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE DEVICE ALARMED A DISCONNECTION OF THE INFUSION LINE DURING THE NIGHT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16745882 ↗
• MalfunctionOct 31, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE WHILE REMOVING THE NEEDLE, SHORT TUBE WAS NO LONGER PALPABLE. IT COULD NOT EVEN BE FELT AT THE PATIENT ANYMORE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15700395 ↗
• MalfunctionOct 27, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE WHILE REMOVING THE NEEDLE, SHORT TUBE WAS NO LONGER PALPABLE. IT COULD NOT EVEN BE FELT AT THE PATIENT ANYMORE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15680161 ↗
• MalfunctionOct 27, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE WHILE REMOVING THE NEEDLE, SHORT TUBE WAS NO LONGER PALPABLE. IT COULD NOT EVEN BE FELT AT THE PATIENT ANYMORE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15680102 ↗
• MalfunctionSep 7, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT THE TUBE BECAME DISCONNECTED FROM THE DISC. THE NURSES DO HOURLY CHECK OF THE TUBING AND SITE SO THE PROBLEM WAS CAUGHT EARLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15369422 ↗
• MalfunctionSep 7, 2022Material Perforation; Material Perforation

  IT WAS REPORTED THAT THE CLIENT HAD HIGH BLOOD GLUCOSE LEVELS WITH MULTIPLE CATHETERS AND WHEN THE NEEDLE WAS TRIGGERED, IT PERFORATED THE CATHETER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Hyperglycemia

  MAUDE report 15369109 ↗
• MalfunctionSep 5, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS A LEAKAGE FROM TUBING OBSERVED DURING INFUSION BELOW THE SCREW THREAD. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15354224 ↗
• MalfunctionApr 4, 2022Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED REGARDING A CADD CLEO INFUSION SET BEING USED TO INFUSE APOMORPHINE. IT WAS REPORTED THAT THE PATIENT OBSERVED A LEAKAGE AT THE ADAPTER BETWEEN THE TUBING AND THE CATHETER, AFTER A FEW HOURS OF INSERTION. THERE WAS NO PATIENT, OR CLINICIAN INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14003226 ↗
• InjuryJun 24, 2020Loss of or Failure to Bond; Infusion or Flow Problem; Loss of or Failure to Bond; Infusion or Flow Problem

  INFORMATION RECEIVED A SMITH MEDICAL CLEO INFUSION SET HAD SEVERAL MALFUNCTIONS WHERE IT CAUSED CONSUMER TO HAVE COMPLICATIONS ASSOCIATED WITH DIABETES. FIRST NOTED THE SPRING DID NOT WORK. SECONDLY, THE GLUE BETWEEN THE PLASTIC TAPE AND SOLID PART OF DEVICE WAS NOT STICKING; AFTER ONE HOUR SEPARATED. THE REPORT STATES LISTED ABOVE MALFUNCTIONS CAUSED HER TO HAVE HYPERGLYCEMIA AND CLOSE MONITORING OF BLOOD GLUCOSE LEVELS,CHECKING FOR KETONES IN URINE, WHICH SUBSEQUENTIALLY CAUSED INTERVENTIONS OF INSULIN SLIDING SCALE INJECTIONS WITH AIDE FROM HOSPITAL NURSE. ONE OTHER OCCASION TH TUBE SEPARATED FROM THE ADHESIVE. THE CONSUMER PROVIDED PICTURES OF THE MALFUNCTIONS. NO OTHER LONG TERM ADVERSE EVENTS REPORTED. HYPERGLYCEMIA CAN CAUSE DIABETIC KETOACIDOSIS. INTERVENTIONS WERE REQUIRED TO PRECLUDE SERIOUS INJURY FOR RISK OF KIDNEY FAILURE, HEART AND MOST COMMON CEREBRAL EDEMA. CRITICAL CARE WOULD NEED TO BE IMPLEMENTED TO STABILIZE THE PATIENT.

  Patient problems: Hyperglycemia

  MAUDE report 10189838 ↗
• InjuryNov 15, 2019Loss of or Failure to Bond; Infusion or Flow Problem; Loss of or Failure to Bond; Infusion or Flow Problem

  INFORMATION RECEIVED A SMITH MEDICAL CLEO INFUSION SET HAD SEVERAL MALFUNCTIONS WHERE IT CAUSED CONSUMER TO HAVE COMPLICATIONS ASSOCIATED WITH DIABETES. FIRST NOTED THE SPRING DID NOT WORK. SECONDLY ,THE GLUE BETWEEN THE PLASTIC TAPE AND SOLID PART OF DEVICE WAS NOT STICKING; AFTER ONE HOUR SEPARATED. THE REPORT STATES LISTED ABOVE MALFUNCTIONS CAUSED HER TO HAVE HYPERGLYCEMIA AND CLOSE MONITORING OF BLOOD GLUCOSE LEVELS,CHECKING FOR KETONES IN URINE, WHICH SUBSEQUENTIALLY CAUSED INTERVENTIONS OF INSULIN SLIDING SCALE INJECTIONS WITH AIDE FROM HOSPITAL NURSE. ONE OTHER OCCASION TH TUBE SEPARATED FROM THE ADHESIVE. THE CONSUMER PROVIDED PICTURES OF THE MALFUNCTIONS. NO OTHER LONG TERM ADVERSE EVENTS REPORTED. HYPERGLYCEMIA CAN CAUSE DIABETIC KETOACIDOSIS. INTERVENTIONS WERE REQUIRED TO PRECLUDE SERIOUS INJURY FOR RISK OF KIDNEY FAILURE, HEART AND MOST COMMON CEREBRAL EDEMA. CRITICAL CARE WOULD NEED TO BE IMPLEMENTED TO STABILIZE THE PATIENT.

  Patient problems: Hyperglycemia

  MAUDE report 9329667 ↗
• InjuryNov 14, 2019Loss of or Failure to Bond; Infusion or Flow Problem; Loss of or Failure to Bond; Infusion or Flow Problem

  INFORMATION RECEIVED A SMITH MEDICAL CLEO INFUSION SET HAD SEVERAL MALFUNCTIONS WHERE IT CAUSED CONSUMER TO HAVE COMPLICATIONS ASSOCIATED WITH DIABETES. FIRST NOTED THE SPRING DID NOT WORK. SECONDLY ,THE GLUE BETWEEN THE PLASTIC TAPE AND SOLID PART OF DEVICE WAS NOT STICKING; AFTER ONE HOUR SEPARATED. THE REPORT STATES LISTED ABOVE MALFUNCTIONS CAUSED HER TO HAVE HYPERGLYCEMIA AND CLOSE MONITORING OF BLOOD GLUCOSE LEVELS,CHECKING FOR KETONES IN URINE, WHICH SUBSEQUENTIALLY CAUSED INTERVENTIONS OF INSULIN SLIDING SCALE INJECTIONS WITH AIDE FROM HOSPITAL NURSE. ONE OTHER OCCASION TH TUBE SEPARATED FROM THE ADHESIVE. THE CONSUMER PROVIDED PICTURES OF THE MALFUNCTIONS. NO OTHER LONG TERM ADVERSE EVENTS REPORTED. HYPERGLYCEMIA CAN CAUSE DIABETIC KETOACIDOSIS. INTERVENTIONS WERE REQUIRED TO PRECLUDE SERIOUS INJURY FOR RISK OF KIDNEY FAILURE, HEART AND MOST COMMON CEREBRAL EDEMA. CRITICAL CARE WOULD NEED TO BE IMPLEMENTED TO STABILIZE THE PATIENT.

  Patient problems: Hyperglycemia

  MAUDE report 9325446 ↗
• InjuryNov 14, 2019Loss of or Failure to Bond; Infusion or Flow Problem; Loss of or Failure to Bond; Infusion or Flow Problem

  INFORMATION RECEIVED A SMITH MEDICAL CLEO INFUSION SET HAD SEVERAL MALFUNCTIONS WHERE IT CAUSED CONSUMER TO HAVE COMPLICATIONS ASSOCIATED WITH DIABETES. FIRST NOTED THE SPRING DID NOT WORK. SECONDLY ,THE GLUE BETWEEN THE PLASTIC TAPE AND SOLID PART OF DEVICE WAS NOT STICKING; AFTER ONE HOUR SEPARATED. THE REPORT STATES LISTED ABOVE MALFUNCTIONS CAUSED HER TO HAVE HYPERGLYCEMIA AND CLOSE MONITORING OF BLOOD GLUCOSE LEVELS,CHECKING FOR KETONES IN URINE, WHICH SUBSEQUENTIALLY CAUSED INTERVENTIONS OF INSULIN SLIDING SCALE INJECTIONS WITH AIDE FROM HOSPITAL NURSE. ONE OTHER OCCASION TH TUBE SEPARATED FROM THE ADHESIVE. THE CONSUMER PROVIDED PICTURES OF THE MALFUNCTIONS. NO OTHER LONG TERM ADVERSE EVENTS REPORTED. HYPERGLYCEMIA CAN CAUSE DIABETIC KETOACIDOSIS. INTERVENTIONS WERE REQUIRED TO PRECLUDE SERIOUS INJURY FOR RISK OF KIDNEY FAILURE, HEART AND MOST COMMON CEREBRAL EDEMA. CRITICAL CARE WOULD NEED TO BE IMPLEMENTED TO STABILIZE THE PATIENT.

  Patient problems: Hyperglycemia

  MAUDE report 9325296 ↗
• MalfunctionNov 14, 2019Loss of or Failure to Bond; Infusion or Flow Problem; Loss of or Failure to Bond; Infusion or Flow Problem

  INFORMATION RECEIVED A SMITH MEDICAL CLEO INFUSION SET HAD SEVERAL MALFUNCTIONS WHERE IT CAUSED CONSUMER TO HAVE COMPLICATIONS ASSOCIATED WITH DIABETES. FIRST NOTED THE SPRING DID NOT WORK. SECONDLY ,THE GLUE BETWEEN THE PLASTIC TAPE AND SOLID PART OF DEVICE WAS NOT STICKING; AFTER ONE HOUR SEPARATED. THE REPORT STATES LISTED ABOVE MALFUNCTIONS CAUSED HER TO HAVE HYPERGLYCEMIA AND CLOSE MONITORING OF BLOOD GLUCOSE LEVELS,CHECKING FOR KETONES IN URINE, WHICH SUBSEQUENTIALLY CAUSED INTERVENTIONS OF INSULIN SLIDING SCALE INJECTIONS WITH AIDE FROM HOSPITAL NURSE. ONE OTHER OCCASION TH TUBE SEPARATED FROM THE ADHESIVE. THE CONSUMER PROVIDED PICTURES OF THE MALFUNCTIONS. NO OTHER LONG TERM ADVERSE EVENTS REPORTED. HYPERGLYCEMIA CAN CAUSE DIABETIC KETOACIDOSIS. INTERVENTIONS WERE REQURIED TO PRECLUDE SERIOUS INJURY FOR RISK OF KIDNEY FAILURE, HEART AND MOST COMMON CEREBRAL EDEMA. CRITICAL CARE WOULD NEED TO BE IMPLEMETED TO STABALIZE THE PATIENT.

  Patient problems: Hyperglycemia

  MAUDE report 9322658 ↗
• MalfunctionApr 20, 2018Break; Break

  INFORMATION WAS RECEIVED INDICATING THAT FOUR DAYS PRIOR THE CANNULA TO A SMITHS MEDICAL CLEO® 90 INFUSION SET BROKE OFF UNDER THE PATIENT'S SKIN. THE PATIENT REPORTS SEEKING MEDICAL ATTENTION TWO TIMES AND HAS BEEN PRESCRIBED ANTIBIOTICS. COMPLAINTS OF THE SITE BEING REDDENED AND SCABBED OVER. REPORTED THAT IF THE CANNULA DOES NOT COME OUT ON ITS OWN, THE PATIENT WILL HAVE TO GO TO THE EMERGENCY ROOM TO HAVE IT REMOVED. NO FURTHER ADVERSE EFFECTS ARE REPORTED.

  Patient problems: Foreign Body In Patient; Unspecified Infection

  MAUDE report 7447375 ↗
• MalfunctionSep 27, 2017Mechanical Problem; Mechanical Problem

  IT WAS REPORTING THAT DURING PLACEMENT OF A CLEO® 90 INFUSION SET, THE NEEDLE DIDN'T RETRACT INTO THE INSERTER, INSTEAD IT REMAINED STUCK IN THE CANNULA. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6898043 ↗