CADD 21-7310-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10610586032394), received between May 23, 2019 and Jul 9, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (6 reports).

2 FDA recall records name this device's identifier, 2 still open.

9 other recalls cover devices cleared under the same FDA submission (K081156); 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.

Recalls naming this device

1. Dec 9, 2022Open, Classified

   There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms

   Z-0966-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Dec 9, 2022Open, Classified

   There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms

   Z-0964-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25766560 ↗
• MalfunctionApr 28, 2026Particulates

  IT WAS REPORTED THAT DURING INSPECTION ACTIVITIES IN INSPECTION, LABELING, AND PACKAGING (ILP), LEAD PRODUCTION TECHNICIAN IDENTIFIED FIVE (5) UNITS WITH PARTICULATES OUT OF 66 INSPECTED UNITS FOR CSP LOT. THE IR SPECTRUM OF THE PARTICULATE BEST MATCHED THE PLASTIC WHICH MOST LIKELY COMPOSED OF POLYPROPYLENE, THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25022554 ↗
• MalfunctionApr 28, 2026Particulates

  IT WAS REPORTED THAT DURING INSPECTION ACTIVITIES IN INSPECTION, LABELING, AND PACKAGING (ILP), LEAD PRODUCTION TECHNICIAN IDENTIFIED FIVE (5) UNITS WITH PARTICULATES OUT OF 66 INSPECTED UNITS FOR CSP LOT. THE IR SPECTRUM OF THE PARTICULATE BEST MATCHED THE PLASTIC WHICH MOST LIKELY COMPOSED OF POLYPROPYLENE, THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25022396 ↗
• MalfunctionApr 28, 2026Particulates

  IT WAS REPORTED THAT DURING INSPECTION ACTIVITIES IN INSPECTION, LABELING, AND PACKAGING (ILP), LEAD PRODUCTION TECHNICIAN IDENTIFIED FIVE (5) UNITS WITH PARTICULATES OUT OF 66 INSPECTED UNITS FOR CSP LOT. THE IR SPECTRUM OF THE PARTICULATE BEST MATCHED THE PLASTIC WHICH MOST LIKELY COMPOSED OF POLYPROPYLENE, THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25022199 ↗
• MalfunctionApr 28, 2026Particulates

  AN EMAIL FOR RECEIVED REGARDING A 250 ML BLUE CADD MEDICATION CASSETTE RESERVOIR WITH FLOW STOP, CLAMP, FEMALE LUER AND NON-VENTED CAP WITH ITEM NUMBER 21-7310-24 AND LOT NUMBER 6070571: IT WAS REPORTED THAT DURING INSPECTION ACTIVITIES IN INSPECTION, LABELING, AND PACKAGING (ILP), LEAD PRODUCTION TECHNICIAN IDENTIFIED FIVE (5) UNITS WITH PARTICULATES OUT OF 66 INSPECTED UNITS FOR CSP LOT. THE IR SPECTRUM OF THE PARTICULATE BEST MATCHED THE PLASTIC WHICH MOST LIKELY COMPOSED OF POLYPROPYLENE, THE EVENT OCCURRED DURING INSPECTION AT 503B SITE, THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25022159 ↗
• MalfunctionJul 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CASSETTE RESERVOIR HAD A PUNCTURE. THERE WAS NO PATIENT INVOLVEMENT OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412006 ↗
• MalfunctionJun 18, 2025Particulates; Particulates

  IT WAS REPORTED THAT HAIR WAS FOUND INSIDE THE CASSETTE POUCH. FOUR PICTURES ARE ATTACHED. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286135 ↗
• MalfunctionMar 27, 2025Failure to Infuse; Obstruction of Flow; Failure to Infuse; Obstruction of Flow

  IT WAS REPORTED THAT WHILE THE CASSETTE WAS CONNECTED TO THE PUMP, THE DEVICE EXHIBITED AN OCCLUSION ALARM. THERE WAS PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21709772 ↗
• MalfunctionMar 27, 2025Failure to Infuse; Obstruction of Flow; Failure to Infuse; Obstruction of Flow

  IT WAS REPORTED THAT THE PUMP EXHIBITED AN OCCLUSION ALARM AND WOULD NOT ELIMINATE UNLESS THE CASSETTE WAS REMOVED. THERE WAS PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21709390 ↗
• MalfunctionSep 10, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE DEVICE HAD A CASSETTE MALFUNCTION AND WAS UNABLE TO COMPLETE INFUSION. THE CUSTOMER HAD THE PATIENT COME AND IT APPEARED THAT ALL THE MEDICATION HAD INFUSED, THE PUMP HAD NOT ALARMED FOR ANY REASON, BUT THERE WAS MEDICATION RESIDUE WHERE IT HAD APPEARED TO HAVE LEAKED FROM THE CORNER OF THE CASSETTE AND DRIED. IN BOTH INSTANCES THE CUSTOMER NOTICED THAT THE BAG INSIDE THE CASSETTE WHICH HELD THE MEDICATION LOOKED DIFFERENT. IT APPEARED THAT THERE HAD BEEN A CHANGE IN THE DESIGN OF THE CADD BLUE MEDICATION CASSETTE RESERVOIR FOR PORTABLE CHEMO INFUSIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20184531 ↗
• MalfunctionJun 22, 2023Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THE CUSTOMER STATED THAT DURING THE PREPARATION OF THE DISPOSABLE, EVERYTHING WORKED WELL, BUT AS SOON AS THE PATIENT WENT HOME, THE LIQUID BEGAN TO LEAK. THE EVENT OCCURRED DURING USE WITH A PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17185147 ↗
• MalfunctionMay 11, 2023Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THE DISPOSABLE WAS IN USE BY TWO SEPARATE PATIENTS, BOTH USING A SEPARATE DEVICES PROGRAMMED FOR PCA USE. THEY HAD NO SIMILAR ISSUES PRIOR TO THE USE OF THIS LOT NUMBER. THE DISPOSABLES IN QUESTION WERE COMPOUNDED ON DIFFERENT DAYS AND QUANTITY OF FLUID ADDED TO THE RESERVOIR HAS BEEN VERIFIED TO BE CORRECT BY MULTIPLE PHARMACISTS ON THEIR STAFF. THESE RESERVOIRS RAN EMPTY DESPITE SHOWING ANYWHERE BETWEEN 24.7ML - 56ML REMAINING IN THE RESERVOIR. DEVICE PROGRAMMING AND OVERALL USE VERIFIED USING THE DEVICE REPORT FEATURES. THEY ARE QUARANTINING THE SPECIFIC LOT FOR A LONG TIME BEING. 250 CADD RESERVOIRS RUN OUT EARLY ON PATIENTS.

  Patient problems: Inadequate Pain Relief; Insufficient Information

  MAUDE report 16915860 ↗
• MalfunctionMay 11, 2023Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THE DISPOSABLE WAS IN USE BY TWO SEPARATE PATIENTS, BOTH USING A SEPARATE DEVICES PROGRAMMED FOR PCA USE. THEY HAD NO SIMILAR ISSUES PRIOR TO THE USE OF THIS LOT NUMBER. THE DISPOSABLES IN QUESTION WERE COMPOUNDED ON DIFFERENT DAYS AND QUANTITY OF FLUID ADDED TO THE RESERVOIR HAS BEEN VERIFIED TO BE CORRECT BY MULTIPLE PHARMACISTS ON THEIR STAFF. THESE RESERVOIRS RAN EMPTY DESPITE SHOWING ANYWHERE BETWEEN 24.7ML - 56ML REMAINING IN THE RESERVOIR. DEVICE PROGRAMMING AND OVERALL USE VERIFIED USING THE DEVICE REPORT FEATURES. THEY ARE QUARANTINING THE SPECIFIC LOT FOR A LONG TIME BEING. 250 CADD RESERVOIRS RUN OUT EARLY ON PATIENTS.

  Patient problems: Inadequate Pain Relief; Insufficient Information

  MAUDE report 16914630 ↗
• MalfunctionMay 11, 2023Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THE DISPOSABLE WAS IN USE BY TWO SEPARATE PATIENTS, BOTH USING A SEPARATE DEVICES PROGRAMMED FOR PCA USE. THEY HAD NO SIMILAR ISSUES PRIOR TO THE USE OF THIS LOT NUMBER. THE DISPOSABLES IN QUESTION WERE COMPOUNDED ON DIFFERENT DAYS AND QUANTITY OF FLUID ADDED TO THE RESERVOIR HAS BEEN VERIFIED TO BE CORRECT BY MULTIPLE PHARMACISTS ON THEIR STAFF. THESE RESERVOIRS RAN EMPTY DESPITE SHOWING ANYWHERE BETWEEN 24.7ML - 56ML REMAINING IN THE RESERVOIR. DEVICE PROGRAMMING AND OVERALL USE VERIFIED USING THE DEVICE REPORT FEATURES. THEY ARE QUARANTINING THE SPECIFIC LOT FOR A LONG TIME BEING. 250 CADD RESERVOIRS RUN OUT EARLY ON PATIENTS.

  Patient problems: Inadequate Pain Relief; Insufficient Information

  MAUDE report 16914617 ↗
• MalfunctionMay 11, 2023Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THE DISPOSABLE WAS IN USE BY TWO SEPARATE PATIENTS, BOTH USING A SEPARATE DEVICES PROGRAMMED FOR PCA USE. THEY HAD NO SIMILAR ISSUES PRIOR TO THE USE OF THIS LOT NUMBER. THE DISPOSABLES IN QUESTION WERE COMPOUNDED ON DIFFERENT DAYS AND QUANTITY OF FLUID ADDED TO THE RESERVOIR HAS BEEN VERIFIED TO BE CORRECT BY MULTIPLE PHARMACISTS ON THEIR STAFF. THESE RESERVOIRS RAN EMPTY DESPITE SHOWING ANYWHERE BETWEEN 24.7ML - 56ML REMAINING IN THE RESERVOIR. DEVICE PROGRAMMING AND OVERALL USE VERIFIED USING THE DEVICE REPORT FEATURES. THEY ARE QUARANTINING THE SPECIFIC LOT FOR A LONG TIME BEING. 250 CADD RESERVOIRS RUN OUT EARLY ON PATIENTS.

  Patient problems: Inadequate Pain Relief; Insufficient Information

  MAUDE report 16914521 ↗
• MalfunctionAug 19, 2021Device Alarm System; Device Alarm System

  INFORMATION WAS RECEIVED INDICATING THAT WHILE IN USE OF A SMITHS MEDICAL CADD CASSETTE RESERVOIR, A NO DISPOSABLE ALARM WAS NOTED. IT WAS ALSO REPORTED THAT THE PATIENT WAS MISSING CHEMOTHERAPY, ANTIBIOTIC AND PAIN MANAGEMENT. NO FURTHER ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12344815 ↗
• MalfunctionJun 29, 2021Device Alarm System; Device Alarm System

  INFORMATION WAS RECEIVED INDICATING THAT WHILE IN USE OF A SMITHS MEDICAL CADD CASSETTE RESERVOIR, A NO DISPOSABLE ALARM WAS NOTED. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12086111 ↗
• MalfunctionJun 6, 2021Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT WHEN THE SMITHS MEDICAL CASSETTE WAS ATTACHED TO A SMITHS MEDICAL PUMP, THE PUMP ALARMED "NO DISPOSABLE." NEW CASSETTE COMPOUNDED : HYDROMORPHONE 5 G 250ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11944655 ↗
• MalfunctionMay 24, 2019Device Alarm System; Device Alarm System

  INFORMATION WAS RECEIVED THAT DURING THE USE OF A SMITHS MEDICAL CADD CASSETTE RESERVOIRS, THE PUMP HAD TO BE STOPPED DUE TO CONTINUOUS "AIR IN LINE" ALARM. IT WAS REPORTED THAT THE PATIENT RETURNED THE PUMP TO THE FACILITY AND THE BIOMEDICAL DEPARTMENT COULD NOT CONFIRM ANY PRODUCT PROBLEMS. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8641378 ↗
• MalfunctionMay 23, 2019Device Alarm System; Device Alarm System

  INFORMATION WAS RECEIVED INDICATING THAT DURING THE USE OF A SMITHS MEDICAL CADD CASSETTE RESERVOIR, THE PUMP HAD TO BE STOPPED DUE TO A CONTINUOUS "AIR IN LINE" ALARM WHILE AT HOME. AFTER THE PATIENT RETURNED THE PRODUCT TO THE FACILITY, THE REPORTER INDICATED THAT THE CUSTOMER CANCELLED THE COMPLAINT BECAUSE THEIR BIOMEDICAL DEPARTMENT COULD NOT CONFIRM ANY PRODUCT PROBLEMS. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8637925 ↗
• MalfunctionMay 23, 2019Device Alarm System; Device Alarm System

  INFORMATION WAS RECEIVED INDICATING THAT DURING THE USE OF A SMITHS MEDICAL CADD CASSETTE RESERVOIR, THE PUMP HAD TO BE STOPPED DUE TO A CONTINUOUS "AIR IN LINE" ALARM WHILE AT HOME. AFTER THE PATIENT RETURNED THE PRODUCT TO THE FACILITY, THE REPORTER INDICATED THAT THE CUSTOMER CANCELLED THE COMPLAINT BECAUSE THEIR BIOMEDICAL DEPARTMENT COULD NOT CONFIRM ANY PRODUCT PROBLEMS. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8637922 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081156. One submission often covers many models, so check the product and lot details in each record.

• Z-0011-2025 · Jun 26, 2024 · Open, Classified
  CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
• Z-0015-2025 · Jun 26, 2024 · Open, Classified
  CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP
• Z-0016-2025 · Jun 26, 2024 · Open, Classified
  CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP
• Z-0014-2025 · Jun 26, 2024 · Open, Classified
  CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24
• Z-0018-2025 · Jun 26, 2024 · Open, Classified
  ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28
• Z-0013-2025 · Jun 26, 2024 · Open, Classified
  CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24
• Z-0012-2025 · Jun 26, 2024 · Open, Classified
  CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
• Z-0010-2025 · Jun 26, 2024 · Open, Classified
  CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
• Z-0017-2025 · Jun 26, 2024 · Open, Classified
  ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28