CADD 21-7357-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10610586027390), received between Sep 21, 2018 and Sep 15, 2025 — classified as 1 injury, 36 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT EXPERIENCED LEAKAGE WITH THE TUBING SET, AT ONE OF THE END CONNECTIONS. THIS ISSUE OCCURRED ON THREE SEPARATE OCCASIONS WITH THE SAME PATIENT. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23057520 ↗
• MalfunctionSep 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT EXPERIENCED LEAKAGE WITH THE TUBING SET, AT ONE OF THE END CONNECTIONS. THIS ISSUE OCCURRED ON THREE SEPARATE OCCASIONS WITH THE SAME PATIENT. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23057492 ↗
• MalfunctionSep 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT EXPERIENCED LEAKAGE WITH THE TUBING SET, AT ONE OF THE END CONNECTIONS. THIS ISSUE OCCURRED ON THREE SEPARATE OCCASIONS WITH THE SAME PATIENT. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23057449 ↗
• MalfunctionJun 19, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PUMP UNDER DELIVERED A DOSE OF INTRAVENOUS IMMUNOGLOBULIN (IVIG). THE PATIENT'S INITIALS ARE (B)(6), BORN ON (B)(6) 1969, MALE, WHITE 182.98 LBS. INFUSION GOT CUT SHORT. THE EVENT OCCURRED DURING INFUSION. NO PATIENT INJURY WAS REPORTED. THE EVENT OCCURRED DURING INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293253 ↗
• MalfunctionJun 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT FLUID SOAKED THROUGH PATIENT'S INFUSION BACKPACK DURING INFUSION (ABOUT 13 HOURS INTO 16 HOUR INFUSION). INFUSION WAS DISCONTINUED AND REMAINDER OF SOLUTION WAS DISCARDED DUE TO CONCERN FOR CONTAMINATION. LEAKING OCCURRED ON THE DOWNSTREAM SIDE OF THE PUMP. THERE WAS A DELAY IN THERAPY. THERE WAS NO ADVERSE/HARM EVENT REPORTED. THE PRODUCT IS NOT CONTAMINATED AND DOES NOT CONTAIN A BIOHAZARD OR CHEMOTHERAPEUTIC AGENT. THE MEDICATION USED WAS PARENTERAL NUTRITION WITHOUT LIPIDS. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203009 ↗
• MalfunctionApr 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A LEAK WAS DETECTED AT INITIATION OF MEDICATION INFUSION. TUBING WAS INSPECTED AND DEFECT DETECTED. DISCOVERED DURING PRIMING. NO DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21902038 ↗
• MalfunctionNov 13, 2024Inaccurate Information; Inaccurate Information

  IT WAS STATED THAT THE CUSTOMER RECEIVED AT LEAST ONE PACKAGE OF REF 21-7357-24 (PER THE BACK OF THE PACKAGE) TUBING (WITHOUT FILTER) BUT THE FLIP SIDE OF THE PACKAGING PAPER INFORMATION SHOWED A PICTURE OF A 1.2 MICRON FILTER ATTACHED TO THE TUBING, APPEARS TO BE INFORMATION FOR REF 21-7364-24 (TUBING WITH FILTER). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678059 ↗
• MalfunctionJan 11, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING INFUSION, THE HIGH VOLUME ADMINISTRATION SET TUBING DETACHED FROM THE CLAVE AT THE END OF THE TUBING AND A SCANT AMOUNT OF LIQUID WAS LEAKING. THE TUBING WAS DISCONNECTED AND RECONNECTED AND INFUSION CONTINUED WITHOUT INCIDENT. AT THE END OF THE INFUSION, WHEN THE TUBING WAS DISCONNECTED FROM THE PATIENT, THE TUBING DISLODGED FROM THE CLAVE AT THE END. IT WAS NOTED THAT THE PATIENT HAD RECEIVED THE FULL DOSE OF MEDICATION PRIOR TO THE TUBING COMING APART AND THEREFORE DID NOT REQUIRE ANY ADDITIONAL INTERVENTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18496926 ↗
• MalfunctionDec 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE END OF THE INFUSION SET (BCV) WAS ATTACHED THE END OF THE PICC, BUT THE REST OF THE SET HAD COME LOOSE AND WAS HANGING BESIDE THE PATIENT. THE ADMIN SET WAS SCREWED ON NORMALLY AND THE NURSE DIDN´T NOTICE ANYTHING ODD. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18378714 ↗
• MalfunctionDec 7, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED A PATIENT HAD ON A HIGH VOLUME INFUSION OVERNIGHT AND IT HAD AIR IN LINE AT THE END OF THE INFUSION THAT WAS NOT DETECTED. THERE WAS APPROXIMATELY 70.2 ML LEFT OF THE 2L INFUSION. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER. PUMP SETTINGS: RATE: 91 ML/HOUR; AMOUNT GIVEN: 1929.8 ML RESERVOIR VOLUME: 70.2 ML. DRUG REGIMEN: 3680 MG MESNA IN 2000 ML NS CADD PUMP INFUSION OVER 22 HOURS. START TIME WAS 14:45 ON (B)(6) 2023, END TIME WAS 12:04 ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18288290 ↗
• MalfunctionSep 19, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE TUBING DISCONNECTED FROM ITS OWN PORT. PATIENT INVOLVEMENT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17776887 ↗
• MalfunctionSep 19, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE TUBING DISCONNECTED FROM ITS OWN PORT. PATIENT INVOLVEMENT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17776885 ↗
• MalfunctionSep 19, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE TUBING DISCONNECTED FROM ITS OWN PORT. PATIENT INVOLVEMENT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17776868 ↗
• MalfunctionJun 29, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING WAS LEAKING WHERE THE TUBING ATTACHED TO THE CASSETTE. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17228761 ↗
• MalfunctionJun 6, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THE DISPOSABLE HAD A PIN HOLE TYPE LEAK DURING INFUSION. PER THE PATIENT THE LEAK WAS IN THE MIDDLE OF THE TUBING. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17075538 ↗
• MalfunctionJun 1, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED, THE DISPOSABLE HAD A PIN HOLE TYPE LEAK DURING INFUSION. PER THE PATIENT, THE LEAK WAS IN THE MIDDLE OF THE TUBING. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17040417 ↗
• MalfunctionMar 22, 2023Product Quality Problem; Inaccurate Delivery; Product Quality Problem; Inaccurate Delivery

  IT WAS REPORTED THAT DURING AN INFUSION, THE TUBING DETACHED FROM THE SPIKE PORTION, CAUSING DRUG TO BE LOST. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16591463 ↗
• InjuryMar 13, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE DEVICE WAS DISCONNECTED AT PATIENT END AT THE WHITE LUER CONNECTION; THE TUBING CAME OUT LEAVING THE CONNECTOR STILL IN CENTRAL LINE, LEAVING THE LINE EXPOSED. IT WAS REPORTED THAT MEDICAL INTERVENTION WAS REQUIRED - PICC REMOVAL, ADMINISTRATION TO WARD, BLOOD CULTURE REQUIRED, AND PICC INSERTION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16531804 ↗
• MalfunctionFeb 9, 2023Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE LINE SNAPPED OFF ITS CAP WHERE IT CONNECTS TO PATIENTS PICC LINE. NO INJURY; HOWEVER, MEDICAL INTERVENTION WAS REQUIRED. THIS INCIDENT HAS RESULTED IN INCREASED CARE FOR THE AFFECTED PATIENT. THIS RESULTED TO HAVING THE PATIENTS PICC LINE REMOVED AND SWITCHED TO PERIPHERAL LINE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 16334003 ↗
• MalfunctionFeb 3, 2023Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THE CHILD HAVE NOT HAD ANY TOTAL PARENTERAL NUTRITION LAST INFUSION. INFUSION LOG SHOW THAT PUMP HAS STARTED AND THE INFUSION HAVE BEEN ON CONTINUOUS INFUSION. WHEN PUMP ALARMED RESERVOIR VOLUME LOW, WEIGHT CONTROL OF INFUSION BAG SHOW THAT NO TPN HAVE INFUSED. NO PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16292170 ↗
• MalfunctionJul 5, 2022Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE DEVICE WAS UNDER INFUSING DURING BENCH TESTING. THERE WAS NO PATIENT INVOLVEMENT OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14918826 ↗
• MalfunctionJul 1, 2022Volume Accuracy Problem; Insufficient Flow or Under Infusion; Volume Accuracy Problem; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT DEVICE UNDER INFUSED DURING BENCH TESTING. THERE WAS NO PATIENT INVOLVEMENT OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14888123 ↗
• MalfunctionJul 1, 2022Volume Accuracy Problem; Insufficient Flow or Under Infusion; Volume Accuracy Problem; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT DEVICE UNDER INFUSED DURING BENCH TESTING. THERE WAS NO PATIENT INVOLVEMENT OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14888008 ↗
• MalfunctionJul 1, 2022Volume Accuracy Problem; Insufficient Flow or Under Infusion; Volume Accuracy Problem; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT DEVICE UNDER INFUSED DURING BENCH TESTING. THERE WAS NO PATIENT INVOLVEMENT OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14887858 ↗
• MalfunctionJun 24, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE PUMP UNDER INFUSION DURING BENCH TESTING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14804832 ↗

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