CADD 21-7361-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 175 adverse event reports that list this exact device (DI 15019517191738), received between Oct 7, 2020 and Jun 12, 2026 — classified as 175 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (50 reports).

3 other recalls cover devices cleared under the same FDA submission (K031361); they may or may not involve this specific model.

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 175 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Break

  AN EVENT INVOLVING A CADD ADMINISTRATION SET REPORTED THAT TUBING WAS BROKE OFF DURING PATIENT USE, WHICH WOULD HAVE RESULTED IN LEAK. SUCH LEAKS COULD EXPOSE CLINICIAN OR PATIENT TO MEDICATION. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25484799 ↗
• MalfunctionJun 8, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE TUBING BECAME DISCONNECTED AT SOME POINT DURING THE NIGHT AND WAS DISCOVERED IN THE MORNING. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25429345 ↗
• MalfunctionMay 14, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT'S TUBING SET FAILED DURING THE NIGHT AND LEAKED FROM THE SMALL HOUSING AROUND THE FILTER, RESULTING IN A LARGE PORTION OF THE TPN SPILLING ONTO THE BED. PER REPORTER, AS A RESULT THE PATIENT DID NOT RECEIVE THE REQUIRED NUTRITION AND MEDICATIONS ON THAT DAY. A PARTIAL DOSE OF MEDICATION WAS MISSED, AND THERE WAS A DELAY IN THERAPY. NO MEDICAL INTERVENTION WAS REQUIRED. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25176814 ↗
• MalfunctionMar 19, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WERE TWO INCIDENTS WITH LEAKS WITH A CADD HIGH VOLUME ADMIN SET TUBING. THE CUSTOMER STATED THERE WAS NO DELAY IN THERAPY, BUT THERE WAS AN ADVERSE EVENT. THERE WAS UNKNOWN REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639797 ↗
• MalfunctionMar 19, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WERE TWO INCIDENTS WITH LEAKS WITH A CADD HIGH VOLUME ADMIN SET TUBING. THE CUSTOMER STATED THERE WAS NO DELAY IN THERAPY, BUT THERE WAS AN ADVERSE EVENT. THERE WAS UNKNOWN REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639569 ↗
• MalfunctionFeb 12, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT TWO CADD GIVING SETS FROM THIS LOT LEAKED AT THE JUNCTION NEAR THE LOADING CASSETTE. THE PATIENT HAD USED OTHER SETS FROM THE SAME LOT WITHOUT ANY LEAKS. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24326658 ↗
• MalfunctionFeb 6, 2026Air/Gas in Device

  IT WAS REPORTED THAT INSTEAD OF THE MEDICATION FLOWING FROM THE BAG TO THE TUBING, IT STARTED PULLING A SMALL AMOUNT OF THE LIQUID IMMUNOGLOBULIN BUT THEN STARTED PULLING AIR INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283740 ↗
• MalfunctionDec 17, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT WHEN ATTEMPTING TO PRIME THE PUMP, ONLY AIR HAD MOVED THROUGH THE LINE. THE TUBING HAD BEEN REMOVED AND REATTACHED, AND THIS TIME, AIR WITH BUBBLES HAD MOVED THROUGH THE LINE. THE EVENT OCCURRED DURING PATIENT USE AND NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829803 ↗
• MalfunctionSep 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT'S HUSBAND OBSERVED LEAKING AT THE CADD TUBING SITE, SPECIFICALLY AT THE POINT OF ATTACHMENT TO THE CADD PUMP, JUST DISTAL TO THE ATTACHMENT POINT. THIS HAD OCCURRED 3¿4 TIMES DURING USE ON THE PATIENT WHILE RECEIVING PARENTERAL NUTRITION THERAPY. THE DEVICE HAD BEEN IN USE FOR APPROXIMATELY 1 TO 2 HOURS. THE INCIDENT RESULTED IN A DELAY IN THERAPY, BUT NO ADVERSE EVENT WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073316 ↗
• MalfunctionSep 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT'S HUSBAND OBSERVED LEAKING AT THE CADD TUBING SITE, SPECIFICALLY AT THE POINT OF ATTACHMENT TO THE CADD PUMP, JUST DISTAL TO THE ATTACHMENT POINT. THIS HAD OCCURRED 3¿4 TIMES DURING USE ON THE PATIENT WHILE RECEIVING PARENTERAL NUTRITION THERAPY. THE DEVICE HAD BEEN IN USE FOR APPROXIMATELY 1 TO 2 HOURS. THE INCIDENT RESULTED IN A DELAY IN THERAPY, BUT NO ADVERSE EVENT WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073290 ↗
• MalfunctionSep 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT'S HUSBAND OBSERVED LEAKING AT THE CADD TUBING SITE, SPECIFICALLY AT THE POINT OF ATTACHMENT TO THE CADD PUMP, JUST DISTAL TO THE ATTACHMENT POINT. THIS HAD OCCURRED 3¿4 TIMES DURING USE ON THE PATIENT WHILE RECEIVING PARENTERAL NUTRITION THERAPY. THE DEVICE HAD BEEN IN USE FOR APPROXIMATELY 1 TO 2 HOURS. THE INCIDENT RESULTED IN A DELAY IN THERAPY, BUT NO ADVERSE EVENT WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073240 ↗
• MalfunctionSep 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT'S HUSBAND OBSERVED LEAKING AT THE CADD TUBING SITE, SPECIFICALLY AT THE POINT OF ATTACHMENT TO THE CADD PUMP, JUST DISTAL TO THE ATTACHMENT POINT. THIS HAD OCCURRED 3¿4 TIMES DURING USE ON THE PATIENT WHILE RECEIVING PARENTERAL NUTRITION THERAPY. THE DEVICE HAD BEEN IN USE FOR APPROXIMATELY 1 TO 2 HOURS. THE INCIDENT RESULTED IN A DELAY IN THERAPY, BUT NO ADVERSE EVENT WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073222 ↗
• MalfunctionSep 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE ADMIN SET WAS BETWEEN THE PUMP SEGMENT AND THE HOSE. THERE WAS NO REPORTED PATIENT INVOLVEMENT. IT WAS STATED THAT THERE WAS NO HUMAN HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952110 ↗
• MalfunctionAug 6, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT IN TWO SEPARATE INSTANCES DURING A FEEDING SESSION, THE TUBING DETACHED FROM THE WHITE CONNECTOR AND LURE LOCK PIECE. THE REPORTER STATED TO INVESTIGATE FURTHER, THE USER TESTED ANOTHER ADMINISTRATION SET FROM THE SAME LOT AND WAS AGAIN ABLE TO PULL THE TUBING APART FROM THE WHITE ADAPTER AND LURE LOCK TIP. HOWEVER, WHEN TESTING A SET FROM A DIFFERENT LOT NUMBER, THE TUBING REMAINED SECURELY ATTACHED AND COULD NOT BE PULLED APART, SUGGESTING A POTENTIAL DEFECT ISOLATED TO THE REPORTED LOT NUMBER. THE SECOND INSTANCE IS CAPTURED ON EMDR-72450.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22726440 ↗
• MalfunctionAug 6, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT IN TWO SEPARATE INSTANCES DURING A FEEDING SESSION, THE TUBING DETACHED FROM THE WHITE CONNECTOR AND LURE LOCK PIECE. THE REPORTER STATED TO INVESTIGATE FURTHER, THE USER TESTED ANOTHER ADMINISTRATION SET FROM THE SAME LOT AND WAS AGAIN ABLE TO PULL THE TUBING APART FROM THE WHITE ADAPTER AND LURE LOCK TIP. HOWEVER, WHEN TESTING A SET FROM A DIFFERENT LOT NUMBER, THE TUBING REMAINED SECURELY ATTACHED AND COULD NOT BE PULLED APART, SUGGESTING A POTENTIAL DEFECT ISOLATED TO THE REPORTED LOT NUMBER. THE SECOND INSTANCE IS CAPTURED ON (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22726414 ↗
• MalfunctionJun 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PUMP EXHIBITED LEAKING WHERE THE CASSETTE CONNECTS TO THE CADD SOLIS VIP PUMP ON THE UPSTREAM SIDE OF THE PUMP. THERE WAS NO ADVERSE/HARM EVENT REPORTED. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22190221 ↗
• MalfunctionMay 13, 2025Failure to Infuse; Obstruction of Flow; Failure to Infuse

  IT WAS REPORTED THAT THE ADMINISTRATION SET IN COMBINATION WITH CADD-SOLIS VIP, ITEM NUMBER 21-2120-0105-14L, ALARMED FOR DOWNSTREAM OCCLUSION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. RELATED COMPLAINT FOR CADD-SOLIS VIP, ITEM NUMBER 21-2120-0105-14L IS DOCUMENTED ON (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22014314 ↗
• MalfunctionMar 21, 2025Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT THE TUBING WAS NOT CALIBRATING CORRECTLY WHEN CONNECTED TO A PUMP. THEY ALREADY USED 2 PUMPS BUT STILL NOT DELIVERING WITH THE RIGHT AMOUNT OF DOSES. THERE WERE NO ISSUES WITH THE 2 PUMPS; BECAUSE WHEN THEY USED THE THIRD PUMP RIGHT NOW, THE TUBING IS STILL NOT DELIVERING. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED. ADDITIONAL INFORMATION REPORTED THAT USER RECEIVED A NEW LOT NUMBER AND HAD NO PROBLEM WITH DELIVERING FULL DOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21665761 ↗
• MalfunctionMar 14, 2025Disconnection; Disconnection

  IT WAS STATED THAT THE TUBING DISCONNECTED FROM THE LUER LOCK DURING AN ONGOING INFUSION IN THE TUNNELED CENTRAL VENOUS CATHETER. THE EVENT WHILE IN USE WITH A PATIENT, WITH PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21612346 ↗
• MalfunctionMar 10, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT A PATIENT REPORTED AN AIR IN LINE ALARM ISSUE. THERE WAS A PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21567257 ↗
• MalfunctionMar 10, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT A PATIENT REPORTED AN AIR IN LINE ALARM ISSUE. THERE WAS A PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21566163 ↗
• MalfunctionJan 24, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS A LEAKAGE ISSUE DUE TO COMPLETE DISCONNECTION OF THE LUER LOCK. THERE WAS UNKNOWN PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21229608 ↗
• MalfunctionJan 24, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS A LEAKAGE ISSUE. THERE WAS UNKNOWN PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21229414 ↗
• MalfunctionJan 23, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE DEVICE EXHIBITED AN AIR IN LINE ALARM ISSUE. THE EVENT OCCURRED WHILE IN PATIENT USE. THE PATIENT¿S INITIALS ARE K.S BORN ON (B)(6) 1955, FEMALE, WEIGHING 121 LB, AND IDENTIFIED AS WHITE. THE OUTCOME OF THE EVENT IS ONGOING, AS IT HAPPENS A COUPLE OF TIMES A WEEK DURING PATIENTS' INFUSIONS. THERE WAS A PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21224130 ↗
• MalfunctionNov 26, 2024Incomplete or Inadequate Priming; Incomplete or Inadequate Priming

  IT WAS REPORTED THAT THE DEVICE'S "TUBING STOPPED PRIMING." THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20787281 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031361. One submission often covers many models, so check the product and lot details in each record.

• Z-0962-2023 · Dec 9, 2022 · Open, Classified
  CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
• Z-0148-2022 · Jul 14, 2020 · Terminated
  CADD Administration Sets, Model #21-7346-24
• Z-2589-2017 · May 15, 2017 · Terminated
  CADD High Volume Administration Set with FlowStop, 21-7381-24. Product Usage: The CADD High-Volume Administration set is designed for use with the CADD Prizm pump to allow fluid