Cleo 21-7232-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 30610586028414), received between Mar 23, 2017 and Jul 21, 2025 — classified as 27 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (13 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 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED MULTIPLE ADVERSE EVENTS, INCLUDING HEADACHE, FATIGUE, LOSS OF APPETITE, INFUSION SITE PAIN, INFUSION SITE RASH, ADHESIVE TAPE ALLERGY, WEIGHT LOSS, CATHETER SITE-RELATED REACTION, DEVICE DISLODGEMENT, WIRELESS COMMUNICATION ISSUES WITH THE DEVICE, AND OVERALL DISSATISFACTION WITH THE DEVICE. THE PATIENT BEGAN THERAPY WITH REMODULIN (TREPROSTINIL SODIUM, CONCENTRATION 10.0 MG/ML) DELIVERED VIA THE REMUNITY [SELF-FILLED] PUMP. THE REPORTED DOSE WAS 0.03125 G/KG, ADMINISTERED CONTINUOUSLY VIA THE SUBCUTANEOUS (SQ) ROUTE USING A SELF-FILLED CASSETTE CONTAINING 1.9 ML AT A RATE OF 19 L PER HOUR.

  Patient problems: Fatigue; Headache; Rash; Weight Changes

  MAUDE report 22556266 ↗
• MalfunctionAug 27, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE DEVICE HAD COME OFF AT SOME POINT MID-INFUSION. USER ERROR WAS CONSIDERED, BUT NOW, POSSIBLY BEING THE THIRD TIME, THERE IS QUESTION THAT THE GLUE ON THE CLEO INFUSION ¿PORT¿ MAY NOT BE ADEQUATE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED. THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20079694 ↗
• MalfunctionAug 23, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE DEVICE PEELED OFF ON THE BELLY OF THE PATIENT. THE WHITE STICKY GAUZE CAME OFF THE CLEAR CIRCULAR TAPE WHICH HAD REMAINED ON THE TEGADERM DRESSING THAT REMAINED ON THE BELLY. EVENT OCCURRED WHILE IN USE WITH THE PATIENT, THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20048452 ↗
• MalfunctionJul 9, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE DEVICE PEELED OFF ON THE BELLY OF THE PATIENT. THE WHITE STICKY GAUZE CAME OFF THE CLEAR CIRCULAR TAPE WHICH HAD REMAINED ON THE TEGADERM DRESSING THAT REMAINED ON THE BELLY. EVENT OCCURRED WHILE IN USE WITH THE PATIENT, THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19706699 ↗
• MalfunctionJun 11, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT INFUSION DEVICE PLACED ON TOP OF TEGADERM HAS COME OFF, WITH THE PLATE OF THE INFUSION DEVICE SEPARATING FROM THE WHITE STICKY TAPE/DRESSING UNDER THE PLATE. THIS WAS THE FOURTH TIME THERE WERE ISSUES WITH THE INFUSION DEVICE COMING OFF THE PATIENT'S SKIN, RAISING THE QUESTION WHETHER THE GLUE ON THE INFUSION PORT WAS ADEQUATE. THE PATIENT REPLACED THE DEVICE AND RESTARTED THE INFUSION. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509806 ↗
• MalfunctionMay 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT INTO THE PUNCH, INSTEAD IT GOT STUCK TWISTED IN THE USERS SKIN AND WAS DIFFICULT TO REMOVE .NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16901969 ↗
• MalfunctionMay 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, THAT THERE WAS LEAKAGE OBSERVED FROM CATHETER. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16900154 ↗
• MalfunctionApr 21, 2023Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE CANNULA/HUB WAS NOT RELEASING FROM THE INSERTION PIECE/NOT STICKING TO THE SKIN/TEGADERM. TEN 10 BOXES OF THE PRODUCT FROM THE AFFECTED LOT WAS SET TO THE SIDE. I ALSO HAVE 2 OF THE DEFECTIVE SOFT SETS SAVED, (1 WHERE THE NEEDLE IS VISIBLY BENT, AND 1 WHERE THE ADHESIVE DOT DID NOT SEPARATE FROM THE APPLICATOR). NORMALLY, PART OF THE DEVICE IS APPLIED USING A SMALL NEEDLE TO INSERT A SIMILARLY SMALL AND SOFT CANNULA UNDER THE SKIN AS PART OF THE INSERTION PROCESS THE EXTERNAL PORTION OF THE DEVICE IS SECURED TO THE SKIN USING ADHESIVE. BOTH ISSUES WITH THE DEVICE DESCRIBED ABOVE (BEND NEEDLE AND ADHESIVE DOT NOT RELEASING FROM THE APPLICATOR) PREVENTED THE DEVICE FROM BEING INSERTED/APPLIED SUCCESSFULLY. AT THIS TIME, IT DID NOT APPEAR THAT ANY PATIENTS WERE HARMED DUE TO THESE DEFECTS. ADDITIONAL INFORMATION RECEIVED VIA EMAIL, NURSE NOTED THAT AFTER 2 ATTEMPTS TO INSERT A SOFT SET THAT THE ADHESIVE FOR THE CANNULA/HUB WAS NOT STICKING TO THE PATIENT. SOFT SET INSERTION PIECE INSPECTED ON A THIRD UNIT AND NOTED THAT THE NEEDLE WAS BENT. OTHER SOFT SETS FROM THE SAME BOX CHECKED BY NURSE AND SEVERAL NOTED TO HAVE BENT NEEDLES. THEY HAVE EXPERIENCED THE ISSU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16790780 ↗
• MalfunctionApr 21, 2023Material Twisted/Bent; Mechanical Jam; Material Twisted/Bent; Mechanical Jam

  IT WAS REPORTED THAT THE DEVICE HAS BENT NEEDLE AND THE ADHESIVE IS NOT RELEASING FROM THE APPLICATOR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16786565 ↗
• MalfunctionMar 23, 2023Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT, DURING THE CHANGE OF THE SITE, THE CATHETER REMAINED IN THE INJECTION SITE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16598339 ↗
• InjuryDec 6, 2022Break; Break

  IT WAS REPORTED THAT THE NEEDLE BREAKS AND REMAINS PARTIALLY IN THE SKIN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 15926121 ↗
• MalfunctionSep 22, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT HAD PAIN FROM HER GROIN TO HER RIGHT BREAST AS WELL AS SITE PAIN IN HER RIGHT INFUSION SITE. SHE STATES SHE REMOVED THE INFUSION DEVICE, BUT THE CANNULA REMAINED IN HER SKIN. SHE STATES THE PAIN FROM HER GROIN TO HER RIGHT BREAST HAS RESOLVED BUT HER SITE PAIN, ALTHOUGH BETTER, IS STILL PAINFUL. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15464828 ↗
• MalfunctionSep 9, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS A LEAKAGE AT THE CATHETER-TUBING CONNECTION DURING THE DELIVERY OF THE MEDICATION. INSTALLATION SITES WERE CHANGED REGULARLY. THE PATIENT HAD BLOCKAGES BECAUSE OF THIS LEAKAGE. THE LOT NUMBER OF THE INFUSION SET HAS BEEN CHANGED AND THE ISSUE HAS SINCE RESOLVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15395060 ↗
• MalfunctionSep 9, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT CALLED THE EMERGENCY LINE REGARDING TUBING ISSUE, THE TUBING WAS CUT AND ALMOST SEPARATED INTO TWO PIECES. THE CUSTOMER IMMEDIATELY CHANGED TO A NEW TUBING AND STARTED THE INFUSION. THERE WAS NO CHANGES IN BREATHING, CHEST PAIN OR ANY OTHER SYMPTOMS: NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15393847 ↗
• MalfunctionSep 7, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED BY PATIENT THAT THE SITE DOES NOT LAST VERY LONG WITH THE DEVICE AND WILL BE SWITCHING TO ANOTHER BRAND. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15369110 ↗
• MalfunctionSep 6, 2022Break; Break

  IT WAS REPORTED THAT WHEN FLUSHING THE PORT PRIOR TO MEDICATION ADMINISTRATION, FLUID WAS NOTED TO BE UNDER THE DRESSING. THE DRESSING WAS REMOVED FOR INSPECTION AND MULTIPLE PIECES OF PLASTIC FELL OUT FROM UNDER THE DRESSING ALONG WITH THE SALINE. THE KNOB THAT THE NEEDLE INSERTS IN HAD BROKEN OFF FROM THE BASE WITH THE CANNULA STILL ATTACHED TO IT. HALF OF THE OCTAGON SHAPED ENCLOSURE HAD ALSO BROKEN AWAY FROM THE BASE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15361059 ↗
• MalfunctionSep 4, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS A LEAK BETWEEN THE TUBING AND THE DEVICE RIGHT AFTER THE SET'S APPLICATION. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353929 ↗
• MalfunctionAug 31, 2022Leak/Splash; Connection Problem; Material Deformation; Leak/Splash; Connection Problem; Material Deformation

  IT WAS REPORTED THAT THE DEVICE'S OVERLAY ADHESIVE WAS NOT ADHERING TO THE SUBJECT. ADHERENCE TO THE DEVICE IS STRONGER THAN ADHERENCE TO SUBJECT CAUSING LIFTING AND REMOVAL OF THE CATHETER AFTER INSERTION. THE CATHETER WAS DAMAGED AND LEAKAGE WAS ALSO REPORTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15329915 ↗
• MalfunctionAug 31, 2022Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  IT WAS REPORTED THAT THE DEVICE WAS CRUMPLED AND LEAKAGE WAS OBSERVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15329795 ↗
• MalfunctionJun 14, 2022Device Alarm System; Device Alarm System

  (2/2, REFERENCE (B)(6) FOR RELATED COMPLAINTS) (DOCUMENTING CASSETTE 1) PER MEDWATCH MW5109733: SPONTANEOUS CALL: SPOKE WITH PATIENT REGARDING CADD LEGACY PUMP SLOW SINGLE BEEP. PUMP SHOWS NO MESSAGE INITIALLY BUT THEN IT STATES NO DISPOSABLE CLAMP TUBING. ISSUE STARTED ON DAY UNKNOWN 2022 AND PATIENT WAS ABLE TO START THE BACKUP PUMP WITHOUT ISSUES. AUTHOR REVIEWED AND INSTRUCTED PATIENT TO RUN A TEST USING THE OLD PARTIALLY USED CASSETTE AND TO LOOK AT THE AREA WHERE THE BLUE TAB WAS TO SEE IF PART OF THE CASSETTE BLADDER WAS PROTRUDING OUT. PATIENT DID CONFIRM THAT THIS WAS TRUE AND USING A BLUNT DEVICE WAS ABLE TO PUSH THE BLADDER BACK INTO THE CASSETTE. PATIENT REPLACED BATTERIES, STARTED PUMP WHICH BEGAN INFUSING AND CONTINUED TO INFUSE. AUTHOR INSTRUCTED PATIENT TO KEEP THE PUMP RUNNING TO TEST IF IT ALARMS AGAIN FOR ANY REASON AND TO NOTIFY THE PHARMACY AS NEEDED. PATIENT VERBALIZED UNDERSTANDING. CASSETTE LOT NUMBER AND PUMP SERIAL NUMBER UNKNOWN. NO FURTHER INFO. PUMP RETURN TRACKING INFO IS NOT AVAILABLE. PHOTOGRAPHS WERE NOT PROVIDED. THIS IS A CONTINUOUS INFUSION. SET FLOW RATE AND VOLUME DELIVERED ARE UNK. POSITION OF THE PUMP WHEN ALARM OCCURRED IS UNK. DID THE REPOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14690354 ↗
• MalfunctionJun 14, 2022Device Alarm System; Device Alarm System

  IT WAS REPORTED THE PUMP ALARMED NO DISPOSABLE CLAMP TUBING. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14686772 ↗
• MalfunctionApr 11, 2022Loss of or Failure to Bond; Material Twisted/Bent; Loss of or Failure to Bond; Material Twisted/Bent

  IT WAS REPORTED THAT AFTER 2 ATTEMPTS TO INSERT A SOFT SET THAT THE ADHESIVE FOR THE CANNULA/HUB WAS NOT STICKING TO THE PATIENT. SOFT SET INSERTION PIECE INSPECTED ON A THIRD UNIT AND NOTED THAT THE NEEDLE WAS BENT. OTHER SOFT SETS FROM THE SAME BOX CHECKED BY NURSE AND SEVERAL NOTED TO HAVE BENT NEEDLES. WE HAVE ALSO EXPERIENCED THE ISSUE WITH CANNULA/HUB NOT RELEASING FROM THE INSERTION PIECE/NOT STICKING TO THE SKIN/TEGADERM WITH OTHER UNITS (WHERE THERE WAS NO ISSUE WITH BENT NEEDLES). NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14073782 ↗
• MalfunctionOct 12, 2018Device Damaged Prior to Use; Device Damaged Prior to Use

  INFORMATION WAS RECEIVED THAT THE CADD CLEO INFUSION SET HAS A VISIBLE NEEDLE THAT WAS BENT. NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7962539 ↗
• InjurySep 8, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT "THE PATIENT NOTICED THE DETACHMENT OF THE NEEDLE 9MM" AND "THE FILM IV 3000 KEEPING THE NEEDLE IN PLACE FOR INFUSION" OF THE CLEO® 90 INFUSION SET. THE PATIENT WAS RECEIVING REMODULIN 5 MG/ML. THE PATIENT REPORTED MILD DYSPNEA WHEN THE NURSE ARRIVED LATER. THE NURSE NOTED THE PATIENT'S OXYGEN SATURATION LEVEL WAS VERY LOW AT 72% AND PROCEEDED TO INSERT ANOTHER NEEDLE AND RESTORED REMODULIN INFUSION. NO OTHER ADVERSE EVENTS WERE REPORTED.

  Patient problems: Dyspnea; Low Oxygen Saturation

  MAUDE report 6851131 ↗
• InjuryJun 16, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED THAT DURING USE OF A CLEO® 90 INFUSION SET, THE PATIENT'S PUMP ALARMED "INFUSION IS BLOCKED". THE TUBING WAS CHECKED AND WAS "FINE", THE ISSUE WAS WITH THE SITE. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE AROUND 400 MG/DL AT THE TIME OF THE EVENT. TO ADDRESS THE HIGH BLOOD GLUCOSE LEVELS, THE PATIENT ADMINISTERED MANUAL INJECTIONS. NO PERMANENT INJURY WAS REPORTED. SEE MFR: 3012307300-2017-01330, 3012307300-2017-01332, 3012307300-2017-01333, 3012307300-2017-01334, 3012307300-2017-01335, 3012307300-2017-01336, AND 3012307300-2017-01337.

  Patient problems: Hyperglycemia

  MAUDE report 6648262 ↗