CADD 21-7106-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,321 adverse event reports that list this exact device (DI 10610586023279), received between Apr 5, 2017 and Sep 30, 2026 — classified as 12 injuries, 1,309 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (879 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,321 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950884 ↗
• MalfunctionJul 9, 2026

  THE RN EXCHANGED THE CARTRIDGE CONTAINING REMODULIN AND ATTACHED A NEW CADD [CONTINUOUS AMBULATORY DELIVERY DEVICE] EXTENSION TUBING FOR DELIVERY OF THE MEDICATION TO THE PATIENT. WITHIN APPROXIMATELY 30 MINUTES, THE PATIENT WAS EXPERIENCING A NEW ONSET OF SYMPTOMS RELATED TO REMODULIN (VOMITING, FLUSHING, DIAPHORESIS). THE REMODULIN INFUSION WAS STOPPED, THE PHYSICIAN WAS NOTIFIED AND ORDERS RECEIVED FOR TREATMENT OF SYMPTOMS. A NEW CARTRIDGE AND TUBING WAS OBTAINED PRIOR TO RESTARTING THE INFUSION.

  Patient problems: Diaphoresis; Hot Flashes/Flushes; Vomiting

  MAUDE report 25761444 ↗
• MalfunctionJul 9, 2026

  SHORTLY AFTER THE REMODULIN CARTRIDGE AND CADD [CONTINUOUS AMBULATORY DELIVERY DEVICE] EXTENSION TUBING WAS CHANGED, THE PATIENT EXPERIENCED SEVERE SYMPTOMS OF NAUSEA, VOMITING, FLUSHING, DIAPHORESIS, AND CLOUDED HEARING. INFUSION STOPPED, PHYSICIAN NOTIFIED, TREATMENT PROVIDED PER PHYSICIAN ORDERS. A NEW CASSETTE WAS REQUESTED FROM PHARMACY AND NEW TUBING APPLIED. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS WITH THE NEW CASSETTE AND NEW CADD TUBING. NO KNOWN HARM AT THIS TIME.

  Patient problems: Diaphoresis; Hearing Impairment; Nausea; Vomiting

  MAUDE report 25761442 ↗
• MalfunctionJul 9, 2026

  REMODULIN CASSETTE AND CADD [CONTINUOUS AMBULATORY DELIVERY DEVICE] TUBING CHANGED BY RN WITH SECOND RN VERIFICATION. APPROXIMATELY 50 MINUTES LATER, PATIENT EXPERIENCING NEW ONSET CHEST PAIN AND PRESSURE. INFUSION STOPPED. NEW CASSETTE REQUESTED FROM PHARMACY, NEW EXTENSION TUBING PLACED, NEW PERIPHERAL IV PLACED. NO SYMPTOMS EXPERIENCED BY PATIENT AFTER REPLACEMENT OF CASSETTE, TUBING, AND IV. NO KNOWN HARM AT THIS TIME.

  Patient problems: Chest Pain

  MAUDE report 25761372 ↗
• MalfunctionJun 29, 2026Fluid/Blood Leak; Insufficient Flow or Under Infusion; Air/Gas in Device

  IT WAS REPORTED THAT DURING INFUSION WITH CADD EXTENSION SET EXPERIENCED LEAKAGE FROM THE TUBING¿S PLASTIC CIRCULAR ELEMENT. DUE TO THE LEAKAGE, CASSETTES REQUIRED EARLY REPLACEMENT, RESULTING IN A REDUCED DRUG DOSE WITH A TOTAL LOSS OF 3.24 MCG FROM 25.5 ML DILUTED IN THE CASSETTE. DESPITE STRONG PROTECTION OF THE EXTENSION SET, LEAKS WERE OBSERVED IN THE FILTER, LEAVING WET MARKS ON THE PATIENT¿S CLOTHING, ALONG WITH AIR BUBBLES AND STEAM INSIDE THE FILTER. THE EVENT OCCURRED DURING INFUSION. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25659462 ↗
• MalfunctionJun 29, 2026Fluid/Blood Leak; Insufficient Flow or Under Infusion; Air/Gas in Device

  IT WAS REPORTED THAT DURING INFUSION WITH CADD EXTENSION SET EXPERIENCED LEAKAGE FROM THE TUBING¿S PLASTIC CIRCULAR ELEMENT. DUE TO THE LEAKAGE, CASSETTES REQUIRED EARLY REPLACEMENT, RESULTING IN A REDUCED DRUG DOSE WITH A TOTAL LOSS OF 3.24 MCG FROM 25.5 ML DILUTED IN THE CASSETTE. DESPITE STRONG PROTECTION OF THE EXTENSION SET, LEAKS WERE OBSERVED IN THE FILTER, LEAVING WET MARKS ON THE PATIENT¿S CLOTHING, ALONG WITH AIR BUBBLES AND STEAM INSIDE THE FILTER. THE EVENT OCCURRED DURING INFUSION. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25659344 ↗
• MalfunctionMay 25, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE CADD EXTENSION SET FILTER WAS OBSERVED TO DRIP (LEAKING) DURING USE. THE PUMP DID NOT SIGNAL THIS ISSUE AND THE EVENT OCCURRED AT THE PATIENT'S HOUSE. THERE WAS PATIENT INVOLVEMENT AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25272742 ↗
• MalfunctionMay 25, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE CADD EXTENSION SET FILTER WAS OBSERVED TO DRIP (LEAKING) DURING USE. THE PUMP DID NOT SIGNAL THIS ISSUE AND THE EVENT OCCURRED AT THE PATIENT'S HOUSE. THERE WAS PATIENT INVOLVEMENT AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25272735 ↗
• MalfunctionMay 25, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE CADD EXTENSION SET FILTER WAS OBSERVED TO DRIP (LEAKING) DURING USE. THE PUMP DID NOT SIGNAL THIS ISSUE AND THE EVENT OCCURRED AT THE PATIENT'S HOUSE. THERE WAS PATIENT INVOLVEMENT AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25272591 ↗
• MalfunctionApr 10, 2026Fluid/Blood Leak

  IT WAS STATED THAT AT THE TIME OF CHEMOTHERAPY, A LEAK IN THE TUBING FILTER WAS OBSERVED, FIRST BY THE PATIENT AND THEN BY THE MEDICAL TEAM. FOLLOWED BY AN INTERRUPTION OF CHEMOTHERAPY IN ORDER TO PROCEED WITH A CHANGE OF TUBING TO CONTINUE IT. ISSUE OCCURRED AT THE TIME OF USE OF THE PRODUCT, DURING THE PASSAGE IN THE INFUSION, CHEMOTHERAPY, A LEAK WAS FOUND AT THE LEVEL OF THE FILTER. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24838997 ↗
• MalfunctionMar 31, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT PATIENT STATED THAT HER GOWN SLEEVE FELT WET. THE IV TUBING WAS TRACED UP TO THE PUMP, WHICH WAS INFUSING FLUIDS AND WHEN THE CADD TUBING WAS SLIGHTLY FLEXED, FLUID WAS SEEN SPURTING FROM THE TUBING. THE PUMP WAS STOPPED AND THE TUBING WAS DISCONNECTED FROM THE IV. THE TUBING WAS FLUSHED WITH A SALINE SYRINGE TO CLEAR REMAINING MEDICATION, THEN BAGGED AND TAKEN BY THE RN TO SHOW ADMINISTRATION. THE PATIENT WAS AWAKE AND SITTING IN BED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24748762 ↗
• MalfunctionMar 12, 2026Fluid/Blood Leak

  IT WAS REPORTED THE LEAKAGE FROM THE CADD EXTENSION SET AT THE CONNECTION TO THE Q-SITE. THE PATIENT REPLACED IT WITH ANOTHER CADD EXTENSION SET BUT EXPERIENCED THE SAME LEAKING AT THE SAME CONNECTION AREA. THE PATIENT THEN SWITCHED TO AN OLDER CADD EXTENSION SET FROM A PREVIOUS ORDER AND REPORTED NO FURTHER ISSUES. THE PATIENT BELIEVES THE CURRENT CADD EXTENSION SETS MAY BE DEFECTIVE. THERE WAS PATIENT INVOLVEMENT/NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24584652 ↗
• MalfunctionFeb 27, 2026Complete Blockage

  IT WAS REPORTED THAT DURING THE REPAIR OF THE CADD TANK, IT WAS NOT POSSIBLE TO PURGE THE CADD TUBING BECAUSE THE PUMP SOUNDED IN OCCLUSION. A SECOND ATTEMPT WAS MADE WITH A NEW TUBING OF THE SAME LOT NUMBER AND SAME REPORT WAS OBSERVED. THE ISSUE WAS RESOLVED AFTER REPLACING THE TUBING WITH ONE FROM DIFFERENT BATCH NUMBER. THIS CONCERNS 2 SAMPLES. THERE WAS PATIENT INVOLVEMENT. THERE WAS PATIENT INVOLVEMENT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24476506 ↗
• MalfunctionFeb 27, 2026Complete Blockage

  IT WAS REPORTED THAT DURING THE REPAIR OF THE CADD TANK, IT WAS NOT POSSIBLE TO PURGE THE CADD TUBING BECAUSE THE PUMP SOUNDED IN OCCLUSION. A SECOND ATTEMPT WAS MADE WITH A NEW TUBING OF THE SAME LOT NUMBER AND SAME REPORT WAS OBSERVED. THE ISSUE WAS RESOLVED AFTER REPLACING THE TUBING WITH ONE FROM DIFFERENT BATCH NUMBER. THIS CONCERNS 2 SAMPLES. THERE WAS PATIENT INVOLVEMENT. THERE WAS PATIENT INVOLVEMENT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24475702 ↗
• MalfunctionJan 13, 2026Failure to Infuse

  IT WAS REPORTED THAT THE OCCLUSION ALARM SOUNDED. REPLACING THE PUMP DID NOT STOP THE OCCLUSION ALARM, AND THE ALARM ONLY STOPPED AFTER REPLACING THE TUBE. THE CLAMP OF THE TUBE WAS OPEN, AND NO SPECIFIC CLOGGING LOCATION COULD BE FOUND. THE EVENT OCCURRED DURING THE PATIENT USE. THERE WAS NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24061409 ↗
• MalfunctionDec 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE LINE WAS LEAKING AFTER THE PUMP BEGAN BEEPING. THE EVENT OCCURRED WHILE IN USE WITH THE PATIENT, AND NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23897464 ↗
• MalfunctionDec 17, 2025Complete Blockage; Fluid/Blood Leak; Complete Blockage; Fluid/Blood Leak

  THE CUSTOMER RETURNED THE PRODUCT, FOR SOMETHING STRANGE WAS NOTICED WHILE FILLING OUT THE ROUTE. DURING DEVICE EVALUATION, A LEAK AND DOWNSTREAM OCCLUSION ALARM WERE IDENTIFIED. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23827979 ↗
• MalfunctionDec 2, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT INCREASING DIFFICULTY IN REMOVING THE CASSETTE FROM ONE OF HER INFUSION PUMPS, IDENTIFIED BY SERIAL NUMBER. DESPITE ATTEMPTING TROUBLESHOOTING, THE ISSUE PERSISTED AND WORSENED OVER TIME. AS A RESULT, THE PATIENT SWITCHED TO A BACKUP PUMP, WHICH HAS BEEN FUNCTIONING WITHOUT ANY ISSUES. THE AFFECTED PUMP WAS USED DURING A CONTINUOUS INFUSION, ALTHOUGH THE SPECIFIC FLOW RATE AND VOLUME DELIVERED ARE UNKNOWN. THE POSITION OF THE PUMP AT THE TIME OF THE ALARM IS ALSO UNKNOWN. THE PATIENT CONFIRMED THAT THE PRODUCT FAULT OCCURRED WHILE THE DEVICE WAS IN USE, BUT IT DID NOT CAUSE OR CONTRIBUTE TO ANY CLINICAL INJURY. THE ACTUAL DEVICE IS AVAILABLE FOR INVESTIGATION AND WAS REPLACED UPON RETURN. THE PATIENT HAD A BACKUP DEVICE AND WAS ABLE TO SUCCESSFULLY CONTINUE HER LIFE-SUSTAINING INFUSION THERAPY. ADDITIONALLY, THE PATIENT EXPERIENCED AN OCCLUSION ALARM LAST MONTH RELATED TO ONE OF HER EXTENSION TUBINGS. THE ISSUE WAS RESOLVED AFTER REPLACING THE TUBING. THE AFFECTED PRODUCT HAD A LOT NUMBER OF 6108409, BUT THE EXPIRATION DATE IS UNKNOWN. NO PHOTOGRAPHS WERE PROVIDED, AND PUMP RETURN TRACKING INFORMATION IS NOT AVAILABLE. THE OUTCOME OF THE EVENT IS CONSIDERED RES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23696380 ↗
• MalfunctionNov 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS STATED THAT THERE WAS A LARGE NUMBER OF SMALL AIR BUBBLES APPEARED INSIDE THE FILTER. ADDITIONALLY, A SMALL AMOUNT OF FLUID LEAKED FROM THE HOLE. THE EVENT OCCURRED BEFORE PATIENT USE AT PATIENT'S HOME. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617043 ↗
• MalfunctionNov 21, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE PUMP DID ALARM WITH HIGH ALARM DISPLAYED IN THE SCREEN. THE AIR IN LINE WAS DETECTED AND THE PUMP STOPPED. THE PUMP WAS CONNECTED TO A PATIENT WHEN THE EVENT OCCURRED. THERE WAS NO PATIENT HARM OR NO PATIENT INJURY. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT PATIENT'S HOME. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617039 ↗
• MalfunctionNov 21, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE TUBING GOT DISCONNECTED. THEY TRIED TO RECONNECT IT BUT THERE WAS AN AIR BUBBLE IN THE LINE. THE PUMP STOPPED. THE CLAMP WAS CLOSED, REVIEWED SETTINGS AND POWERED THE PUMP OFF. THERE WAS NO PATIENT HARM OR NO PATIENT INJURY. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT PATIENT'S HOME. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617033 ↗
• MalfunctionNov 17, 2025Device Sensing Problem; Air/Gas in Device; Device Sensing Problem; Air/Gas in Device

  IT WAS REPORTED THAT THE PUMP DID NOT ALARM AIR IN LINE. THE DEVICE WAS CONNECTED TO A PATIENT WHEN THE ERROR/EVENT OCCURRED. A CONTINUOUS INFUSION RATE OF 1.389 ML PER HOUR HAD BEEN PROGRAMMED, WITH A TOTAL RESERVOIR VOLUME OF 100 ML AND A GIVEN VOLUME OF 100 ML. THE AIR DETECTOR AND UPSTREAM SENSOR HAD BEEN TURNED ON BUT LOW. THE LENGTH OF INFUSION HAS BEEN SET TO 72 HOURS. A CSTD WAS USED TO FILL THE CASSETTE. THE PUMP WAS NOT USED TO PRIME THE EXTENSION TUBING. THE METHOD USED TO PRIME WAS SYRINGE. NO PATIENT HARM OR NO PATIENT INJURY. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT PATIENT'S HOME. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. ASSOCIATED CASSETTE AND PUMP COMPLAINTS DOCUMENTED ON (B)(4) AND (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23571835 ↗
• MalfunctionNov 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CADD EXTENSION SET WAS LEAKING DURING PRIMING WHILE PERFORMING A CASSETTE CHANGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23571192 ↗
• MalfunctionNov 7, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE DEVICE STARTED LEAKING AFTER THEY LEFT. THE PUMP WAS TURNED OFF. WHEN THEY ARRIVED, IT WOULD NOT TURN ON. THE FLUOROURACIL CRYSTALLIZED AND EVEN MADE ITS WAY INSIDE THE PUMP. THE PUMP WAS REMOVED FROM THE CASSETTE. NO PATIENT HARM OR NO PATIENT INJURY. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT PATIENT'S HOME. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. ASSOCIATED CASSETTE AND PUMP COMPLAINTS DOCUMENTED ON (B)(4) AND (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23498657 ↗
• MalfunctionNov 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS MINOR LEAKAGE AROUND THE FILTER OF THE SET. THE LEAK WAS RESOLVED AT FIRST BUT REAPPEARED AS SMALL DROPS SHORTLY AFTER. THE INFUSION WAS STOPPED, THE SET WAS CHANGED, AND TREATMENT CONTINUED WITHOUT ISSUES FOR THAT CASSETTE. THE NEXT CASSETTE CHANGE OCCURRED ON (B)(6) 2025, WITH NO ISSUES. ON (B)(6) 2025, THE PATIENT CONTACTED THE HOSPITAL TO REPORT A SIMILAR MINOR LEAK AROUND THE FILTER AND RETURNED TO THE HOSPITAL, WHERE STAFF OBTAINED AN ALTERNATIVE CADD GIVING SET FROM THE CHRISTIE HOSPITAL, BASED ON THEIR REPORTED SUCCESSFUL USE OF THIS TYPE. THESE ALTERNATIVE SETS WERE USED FOR THE REMAINDER OF THE TREATMENT CYCLE, WITH NO FURTHER INCIDENTS REPORTED. THERE WAS PATIENT INVOLVEMENT AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23492136 ↗