CADD 21-7321-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10610586029639), received between Mar 5, 2019 and Nov 7, 2025 — classified as 45 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (17 reports).

1 FDA recall record name this device's identifier, 1 still open.

5 other recalls cover devices cleared under the same FDA submission (K040636); 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-0963-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2025Fluid/Blood Leak; Inaccurate Delivery; Fluid/Blood Leak; Inaccurate Delivery

  IT WAS REPORTED THAT AFTER PLACING THE PUMP AFTER AN HOUR, THE PUMP LEAKED A SIGNIFICANT AMOUNT, THEN THE PUMP WAS REPLACED. WHEN THE PATIENT CAME BACK, THE PUMP WAS ALARMING HOURS EARLIER THAN SHOULD HAVE BEEN AND HAD 1.4 ML REMAINING AND THEY COULD NOT POWER PUMP OFF OR ACKNOWLEDGE THE ALARM. 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 PUMP COMPLAINT DOCUMENTED ON (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23498701 ↗
• MalfunctionMar 28, 2025Excess Flow or Over-Infusion; Intermittent Loss of Power; Excess Flow or Over-Infusion; Intermittent Loss of Power

  IT WAS REPORTED THAT THE PUMP TURNED OFF WITH WARNINGS. THE PUMP HAD INDICATED THAT 8 ML REMAINED, ALTHOUGH THE BAG WAS EMPTIED. THE CONTINUOUS INFUSION RATE HAD BEEN 2.5, WITH A TOTAL RESERVOIR VOLUME OF 115. ACCORDING TO THE PUMP, 104.50 HAD BEEN GIVEN, BUT THE PATIENT HAD RECEIVED 115. THERE WAS PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21718875 ↗
• MalfunctionNov 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING BETWEEN THE SPIKE SET, AND THE BAG HAD BEEN LEAKING. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20700545 ↗
• MalfunctionNov 8, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  HOLD MS 11/8 IT WAS REPORTED THAT DURING USE, THE DEVICE SYSTEM UNDER-INFUSED. THE PATIENT PRESENTED TO THE CLINIC AND IT WAS NOTICED THAT THE DEVICE SYSTEM HAD INFUSED ONLY 20ML OUT OF 106ML TOTAL VOLUME AT A RATE OF 2.4ML/HOUR. PER THE REPORTER, THE DEVICE SYSTEM ACTED AS IF IT WAS INFUSING, NO ALARM OCCURRED, AND THE LOW VOLUME AND COMPLETE ALERTS OCCURRED AT THE APPROPRIATE TIMES. THE DEVICE INDICATED THAT THE FULL VOLUME WAS INFUSED AND WAS EMPTY. THE DEVICE SYSTEM WAS PULLED FROM SERVICE AND THE PATIENT WAS TO RETURN TO RECEIVE THE REST OF THE DOSE PER PHYSICIAN ORDER. PER THE REPORTER, THERE WERE NO PATIENT ADVERSE EFFECTS. THE DEVICE WAS NOT TO BE RETURNED TO THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18091968 ↗
• MalfunctionJul 20, 2023Inaccurate Delivery; Improper Flow or Infusion; Inaccurate Delivery; Improper Flow or Infusion

  IT WAS REPORTED THAT THERE ARE LONG DELAYS IN INFUSION TO THE PATIENT WHEN ADMINISTERING CHEMOTHERAPY AND WHEN USED FOR PAIN RELIEF. IT WAS NOTED 5 DIFFERENT DEVIATIONS RELATED TO THE USE OF THE CASSETTES. FOUR CASSETTES WERE USED FOR CHEMOTHERAPY TREATMENT WHICH WAS SIGNIFICANTLY DELAYED. ONE CASSETTE WAS USED IN PAIN MANAGEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 17368413 ↗
• MalfunctionJul 20, 2023Inaccurate Delivery; Improper Flow or Infusion; Inaccurate Delivery; Improper Flow or Infusion

  IT WAS REPORTED THAT THERE ARE LONG DELAYS IN INFUSION TO THE PATIENT WHEN ADMINISTERING CHEMOTHERAPY AND WHEN USED FOR PAIN RELIEF. IT WAS NOTED 5 DIFFERENT DEVIATIONS RELATED TO THE USE OF THE CASSETTES. FOUR CASSETTES WERE USED FOR CHEMOTHERAPY TREATMENT WHICH WAS SIGNIFICANTLY DELAYED. ONE CASSETTE WAS USED IN PAIN MANAGEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 17368412 ↗
• MalfunctionJul 20, 2023Inaccurate Delivery; Improper Flow or Infusion; Inaccurate Delivery; Improper Flow or Infusion

  IT WAS REPORTED THAT THERE ARE LONG DELAYS IN INFUSION TO THE PATIENT WHEN ADMINISTERING CHEMOTHERAPY AND WHEN USED FOR PAIN RELIEF. IT WAS NOTED 5 DIFFERENT DEVIATIONS RELATED TO THE USE OF THE CASSETTES. FOUR CASSETTES WERE USED FOR CHEMOTHERAPY TREATMENT WHICH WAS SIGNIFICANTLY DELAYED. ONE CASSETTE WAS USED IN PAIN MANAGEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 17368411 ↗
• MalfunctionJul 20, 2023Inaccurate Delivery; Improper Flow or Infusion; Inaccurate Delivery; Improper Flow or Infusion

  IT WAS REPORTED THAT THERE ARE LONG DELAYS IN INFUSION TO THE PATIENT WHEN ADMINISTERING CHEMOTHERAPY AND WHEN USED FOR PAIN RELIEF. IT WAS NOTED 5 DIFFERENT DEVIATIONS RELATED TO THE USE OF THE CASSETTES. FOUR CASSETTES WERE USED FOR CHEMOTHERAPY TREATMENT WHICH WAS SIGNIFICANTLY DELAYED. ONE CASSETTE WAS USED IN PAIN MANAGEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 17368407 ↗
• MalfunctionJul 20, 2023Inaccurate Delivery; Improper Flow or Infusion; Inaccurate Delivery; Improper Flow or Infusion

  IT WAS REPORTED THAT THERE ARE LONG DELAYS IN INFUSION TO THE PATIENT WHEN ADMINISTERING CHEMOTHERAPY AND WHEN USED FOR PAIN RELIEF. IT WAS NOTED 5 DIFFERENT DEVIATIONS RELATED TO THE USE OF THE CASSETTES. FOUR CASSETTES WERE USED FOR CHEMOTHERAPY TREATMENT WHICH WAS SIGNIFICANTLY DELAYED. ONE CASSETTE WAS USED IN PAIN MANAGEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 17368405 ↗
• MalfunctionJan 4, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER TOOK THE ADMINISTRATION SET THAT WAS RETURNED FROM THE PATIENT WHO RECENTLY EXPERIENCED THE LEAK AND DID A TEST WITH SALINE. WHEN SHE OPENS THE GREEN CLIP TO START THE FLUID FLOW, THE SALINE LEAKS OUT FROM THE TUBING. ALSO INCLUDED A CLOSE UP PHOTO OF THE AREA OF THE TUBING WHICH APPEARS TO BE COMPROMISED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16095017 ↗
• MalfunctionDec 2, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE PUMP WAS NOT INFUSING AT ALL. THE PUMP'S LOG SHOWS THAT THE MEDICATION HAS BEEN GIVEN, AS DOES THE LOG. THE ADMINISTRATION SET WAS CLEAN AND CONTAINING SODIUM CHLORIDE (NACL). THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15904729 ↗
• MalfunctionNov 4, 2022Device Alarm System; Obstruction of Flow; Device Alarm System; Obstruction of Flow

  ADDITIONAL INFORMATION WAS RECEIVED BY THE MANUFACTURER ON 11/1/2022. PATIENT INFORMATION WAS PROVIDED. THE PATIENT IS ABLE TO RETURN THE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15730466 ↗
• MalfunctionNov 4, 2022Device Alarm System; Obstruction of Flow; Device Alarm System; Obstruction of Flow

  IT WAS REPORTED THAT THE PUMP EXHIBITED A BLOCKAGE DETECTED ERROR MESSAGE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15725895 ↗
• MalfunctionNov 4, 2022Device Alarm System; Obstruction of Flow; Device Alarm System; Obstruction of Flow

  ADDITIONAL INFORMATION WAS RECEIVED BY THE MANUFACTURER ON 11/1/2022. PATIENT INFORMATION WAS PROVIDED. THE PATIENT IS ABLE TO RETURN THE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15724751 ↗
• MalfunctionNov 3, 2022Device Alarm System; Obstruction of Flow; Device Alarm System; Obstruction of Flow

  IT WAS REPORTED THAT THE PUMP EXHIBITED A BLOCKAGE DETECTED ERROR MESSAGE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15722897 ↗
• MalfunctionNov 3, 2022Device Alarm System; Obstruction of Flow; Device Alarm System; Obstruction of Flow

  ADDITIONAL INFORMATION WAS RECEIVED BY THE MANUFACTURER ON (B)(6) 2022. PATIENT INFORMATION WAS PROVIDED. THE PATIENT IS ABLE TO RETURN THE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15721422 ↗
• MalfunctionSep 14, 2022Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE DEVICE UNDER DELIVERED THE MEDICATION. THERE HAS BEEN NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15421893 ↗
• MalfunctionAug 18, 2022Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT THE PUMP WAS NOT DELIVERING WHAT IT WAS SUPPOSED TO GIVE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15252567 ↗
• MalfunctionAug 16, 2022Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT, "THE PUMP HAD TO ADMINISTER 1246 ML OVER FOUR DOSES OF 311 ML/3HOURS WITH AN INTERVAL OF 12 HOURS." AFTER FINISHING THE TREATMENT THERE WAS STILL 350 ML LEFT IN THE BAG WHEN IT SHOULD BE EMPTY. NO ERRORS WERE OBSERVED IN THE LOG. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15234349 ↗
• MalfunctionMay 6, 2022Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE LUER CONNECTOR WAS DEFECTIVE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14310762 ↗
• MalfunctionOct 4, 2021Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT A SMITHS MEDICAL PUMP DISPLAYED A NO DISPOSABLE ALARM RIGHT AT THE INITIAL HOOKUP OF THE PUMP. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12571747 ↗
• MalfunctionSep 18, 2021Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  INFORMATION WAS RECEIVED REGARDING A CADD ADMINISTRATION SET. IT WAS REPORTED THAT THE DEVICE GAVE A "NO DISPOSABLE" ALARM WITH 115ML REMAINING. PUMP SETTINGS ARE UNAVAILABLE. THERE WAS NO PATIENT, OR CLINICIAN INJURY ASSOCIATED WITH THESE OCCURRENCES. NO FURTHER DETAILS PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12493078 ↗
• MalfunctionJul 26, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PUMP WAS LEAKING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12224663 ↗
• MalfunctionFeb 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED REGARDING A CADD ADMINISTRATION SET. IT WAS REPORTED THAT A LEAK OCCURRED AT THE WHILE PART OF THE LEUR LOCK. THE FACILITY REPLACED THE TUBING AND IT LEAKED A SECOND TIME WITH BLOOD BACKING UP INTO THE LINE. THEY DISPOSED OF THE PRODUCT. THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11390991 ↗
• MalfunctionFeb 27, 2021Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED REGARDING A CADD ADMINISTRATION SET. IT WAS REPORTED THAT A LEAK OCCURRED AT THE WHILE PART OF THE LEUR LOCK. THE FACILITY REPLACED THE TUBING AND IT LEAKED A SECOND TIME WITH BLOOD BACKING UP INTO THE LINE. THEY DISPOSED OF THE PRODUCT. THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11389561 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040636. One submission often covers many models, so check the product and lot details in each record.

• Z-2522-2025 · Aug 6, 2025 · Open, Classified
  Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24
• Z-1767-2017 · Mar 17, 2017 · Terminated
  CADD Administration Set, 21-7339-24, Rx Only, Sterile EO.
• Z-1831-2016 · Apr 22, 2016 · Terminated
  CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24, 21-7323-24, 21-7324-01, 21-7324-24, 21-7333-24, 21-7336-01, 21-7336-24
• Z-1286-2015 · Feb 2, 2015 · Terminated
  CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.
• Z-0879-2008 · Dec 14, 2007 · Terminated
  Smiths CADD Yellow Medication Cassette Reservoirs with Flow Stop, Clamp and Female Luer, 100 ml, Reorder No. 21-7300-24, Nonvented stopper included, Sterile, Smiths Medical, St. Pa