CADD 21-7343-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 15019517191820), received between Dec 8, 2020 and May 4, 2026 — classified as 65 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (19 reports).

2 FDA recall records name this device's identifier, 2 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 18, 2026.

Recalls naming this device

1. Dec 9, 2022Class IOpen, 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 ↗

2. Dec 9, 2022Class IOpen, 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED LEAKAGE TWICE WITH THE LINE UTILIZED FOR TPV. THE SECOND TIME, THE LEAKAGE OCCURRED AFTER 4 HOURS OF USE OF THE LINE. THE LINE IS REPLACED DAILY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25072889 ↗
• MalfunctionMay 4, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED LEAKAGE TWICE WITH THE LINE, THE PATIENT USES THE LINE FOR TPV. THE SECOND TIME, THE LEAKAGE OCCURRED AFTER 4 HOURS OF USE OF THE LINE. FOR THE FIRST LEAKAGE, IT IS UNKNOWN AFTER HOW LONG OF USE WHEN THE ISSUE OCCURRED. THE LINE IS REPLACED DAILY. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25072884 ↗
• MalfunctionApr 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE CASSETTE BLUE CAP BROKE AND THE MEDICATION LEAKED OUT, REQUIRED USE OF MEDICATION FROM E-KIT. THE PATIENT HAD A BACKUP PRODUCT SO THAT THEY SWITCHED THE DEVICE AND SUCCESSFULLY CONTINUED THEIR THERAPY. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24792537 ↗
• MalfunctionApr 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS ONE CASSETTE LEAKING MEDICATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791322 ↗
• MalfunctionJan 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE STARTED LEAKING AFTER PRODUCTION. THE CUSTOMER ALSO STATED THAT THE CASSETTE CONTAINS AN OPIATE. THERE WAS NO REPORTED PATIENT INVOLVEMENT. PHOTOS ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24167373 ↗
• MalfunctionJul 18, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT AIR WAS GOING INTO THE IV LINE. THE SITE USED TO USE THE HIGH VOLUME, BUT IT WAS LATER CHANGED TO HYBRID TUBING. THE EVENT HAPPENED DURING PRE-TESTING BEFORE USING DURING PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22545917 ↗
• MalfunctionApr 30, 2025Particulates; Particulates

  IT WAS REPORTED THAT SMALL BLACK DOTS WERE FOUND INSIDE THE CADD ADMIN SET, NEAR THE CONNECTOR. THE EVENT OCCURRED IN THE PATIENT¿S HOME, UPON OPENING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21936096 ↗
• MalfunctionNov 6, 2024Complete Blockage; Failure to Infuse; Complete Blockage; Failure to Infuse

  IT WAS REPORTED THAT 'THE PUMP GIVES AN AIR ALARM EVEN IF THERE IS NO AIR IN THE PIPE. THE ALARM COULD NOT BE RECTIFIED BY ANY MEANS. THE PUMP WAS REPLACED, AND THE PROBLEM PERSISTS. IT WAS DETERMINED THERE WERE NO PROBLEMS WITH THE PUMP, THE PROBLEM WAS SOLVED BY REPLACING THE ADMIN SETS. THE EVENT HAS OCCURRED DURING INFUSION AT THE PATIENT'S HOME. THE USER WAS THE PATIENT, BUT THE INFUSION WAS GIVEN BY THE CARER. THE PATIENT WAS NOT HARMED DURING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622588 ↗
• MalfunctionSep 30, 2024Air/Gas in Device; Air/Gas in Device

  GCM RECEIVED AN EMAIL ON 3-SEPT-2024 FROM DR. (B)(6), PHARMACIST, QUALITY ASSURANCE MANAGER AT (B)(6) REGARDING A SET, ADMIN, CADD, 114", SPIKE, 1.2 FLTR, NAC, FS, TOTM  15/BX LOT NUMBER 4426873 AND ITEM NUMBER 21-7343-24. THE FOLLOWING ISSUE WAS STATED: 'THE PUMP GIVES AN AIR ALARM EVEN IF THERE IS NO AIR IN THE PIPE. THE ALARM COULD NOT BE RECTIFIED BY ANY MEANS. THE PUMP WAS ALSO REPLACED AND THE PROBLEM PERSISTS. 2 LOT NUMBERS ARE AFFECTED: 4448943 AND 4426873. UNFORTUNATELY, THE AFFECTED LINES HAVE ALREADY BEEN REMOVED, BUT I HAVE RECEIVED A TOTAL OF 13 LINES FROM THE TWO LOTS THAT ARE STILL IN THE ORIGINAL PACKAGING. THEY ARE AVAILABLE FOR EXAMINATION.' THE CLIENT ASKED FOR A REPLACEMENT. THERE WAS UNKNOWN PATIENT INVOLVEMENT. (B)(6) 4-SEPT-2024 UPDATE: GCM RECEIVED AN EMAIL FROM (B)(6), PHARMACIST, QUALITY ASSURANCE MANAGER AT (B)(6), WITH THE PICK-UP DETAILS. SHE STATED THAT SHE WILL BE BACK WITH AN EMAIL WITH THE ADDITIONAL INFORMATION ABOUT THE EVENT AS SOON AS SHE HAS THE ANSWERS. (B)(6) 5-SEPT-2024 UPDATE: GCM RECEIVED AN EMAIL FROM (B)(6) ON 11-SEPT-2024 WITH THE FOLLOWING INFORMATION: THERE ARE NO PROBLEMS WITH THE PUMP, THE PROBLEM WAS ACTUALLY SOLVED BY REPLACING TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20332937 ↗
• MalfunctionApr 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WITH THREE PATIENTS DURING INFUSION OF TOTAL PARENTERAL NUTRITION OR INTRAVENOUS NACL THE LINE BROKE. IT IS UNKNOWN IF THERE WERE ANY ADVERSE PATIENT EFFECTS; NONE WERE REPORTED. PATIENT INFORMATION WAS NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19076349 ↗
• MalfunctionMar 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DISPOSABLE SYSTEM HAD BECOME DETACHED FROM THE LUER-LOCK CLOSURE WITHOUT THERE HAVING BEEN ANY TENSION ON IT. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18944696 ↗
• MalfunctionMar 19, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING INFUSION OF TOTAL PARENTERAL NUTRITION (TPN), WITHOUT TENSION ON THE SYSTEM ATTACHMENT, A PIECE OF THE PORT FELL APART. PER THE REPORTER, THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18935663 ↗
• MalfunctionDec 14, 2023Obstruction of Flow; Material Twisted/Bent; Air/Gas in Device; Obstruction of Flow; Material Twisted/Bent; Air/Gas in Device

  IT WAS REPORTED THAT DURING USE, THE PATIENT NOTICED A PIECE OF RUBBER IN THE LINE WHEN PUNCTURING THE RUBBER OF THE INFUSION BAG. IT WAS NOTED THAT THE LINE WAS USED FOR A WEEK AND A NEW BAG WAS CONNECTED THREE TIMES A DAY. IT WAS ALSO REPORTED THAT THE SPIKE SEEMED TO BECOME BENT AFTER A FEW TAPS, AND THERE HAD ALSO BEEN AIR IN THE LINE REGULARLY AFTER THE FILTER TOWARDS THE CLIENT. THE RUBBER IN THE SPIKE OCCASIONALLY CAUSED AN OCCLUSION ALARM. NO PATIENT ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18332547 ↗
• MalfunctionDec 14, 2023Obstruction of Flow; Material Twisted/Bent; Air/Gas in Device; Obstruction of Flow; Material Twisted/Bent; Air/Gas in Device

  IT WAS REPORTED THAT DURING USE, THE PATIENT NOTICED A PIECE OF RUBBER IN THE LINE WHEN PUNCTURING THE RUBBER OF THE INFUSION BAG. IT WAS NOTED THAT THE LINE WAS USED FOR A WEEK AND A NEW BAG WAS CONNECTED THREE TIMES A DAY. IT WAS ALSO REPORTED THAT THE SPIKE SEEMED TO BECOME BENT AFTER A FEW TAPS, AND THERE HAD ALSO BEEN AIR IN THE LINE REGULARLY AFTER THE FILTER TOWARDS THE CLIENT. THE RUBBER IN THE SPIKE OCCASIONALLY CAUSED AN OCCLUSION ALARM. NO PATIENT ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18331202 ↗
• MalfunctionJun 29, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THE DISPOSABLE TUBING WAS LEAKING WHERE THE TUBING ATTACHED TO THE CASSETTE. LOT NUMBER IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17230676 ↗
• MalfunctionMay 26, 2023Device Alarm System; Product Quality Problem; Device Alarm System; Product Quality Problem

  IT WAS REPORTED THE DISPOSABLE SET FELT ABNORMAL AND STIFFER THAN NORMAL. THE PUMP HAS ALSO ALARM DOWNSTREAM OCCLUSION SEVERAL TIMES. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17010932 ↗
• MalfunctionMay 26, 2023Device Alarm System; Product Quality Problem; Device Alarm System; Product Quality Problem

  IT WAS REPORTED THE DISPOSABLE SET FELT ABNORMAL AND STIFFER THAN NORMAL. THE PUMP HAS ALSO ALARM DOWNSTREAM OCCLUSION SEVERAL TIMES. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009865 ↗
• MalfunctionMay 25, 2023Device Alarm System; Product Quality Problem; Device Alarm System; Product Quality Problem

  IT WAS REPORTED THE DISPOSABLE SET FELT ABNORMAL AND STIFFER THAN NORMAL. THE PUMP HAS ALSO ALARM DOWNSTREAM OCCLUSION SEVERAL TIMES. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17007394 ↗
• MalfunctionMay 25, 2023Device Alarm System; Product Quality Problem; Device Alarm System; Product Quality Problem

  IT WAS REPORTED THE DISPOSABLE SET FELT ABNORMAL AND STIFFER THAN NORMAL. THE PUMP HAS ALSO ALARM DOWNSTREAM OCCLUSION SEVERAL TIMES. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17007346 ↗
• MalfunctionMay 10, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE LINES COULD NOT BE VENTED WHILE IN USE WITH THE PUMP. IT WAS POSSIBLE ONLY WITH A FORCE OF GRAVITY. NO INJURY OR PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16904350 ↗
• MalfunctionMay 8, 2023Pumping Problem; Pumping Problem

  IT WAS REPORTED THAT DURING PREFILL, IT WAS NOTICED THAT THE PUMP SUPPOSEDLY REQUIRED 30 MILLILITERS (ML) TO COMPLETELY PREFILL THE SYSTEM, WHICH CLEARLY DID NOT CORRELATE WITH THE VOLUME REMOVED FROM THE RESERVOIR. THE ACTUAL REMEASURED WAS 4ML PHYSICIAN BOLUS AND WITH THIS TARGET OF 4ML, ONLY 2.8ML CAME OUT. THIS DEVIATION SEEMS A BIT LARGE. THE CUSTOMER WAS ABLE TO REPRODUCE THIS ERROR WITH THE SAME SYSTEM ON ANOTHER PUMP. WITH BOTH PUMPS, WE WERE THEN ABLE TO ACTUALLY DISPENSE 4 ML WITH A NEW SYSTEM AT A TARGET OF 4 ML. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16885739 ↗
• MalfunctionJul 11, 2022Leak/Splash; Leak/Splash

  (3/3 REFERENCE (B)(4) FOR RELATED COMPLAINTS) (DOCUMENTING 1/1 LEAKING AT THE SIDE PORT) PER EMAIL: NURSES ARE REPORTING LEAKING TUBING ON THE MILRINONE PATIENTS. THREE INSTANCES OF LEAKING AT THE FILTER AND ONE INSTANCE OF LEAKING FROM THE SIDE PORT OF THE TUBING. THE CADD TUBING NUMBER IS 21-7343-24 AND THE LOT# IS 4232329.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14983109 ↗
• MalfunctionJul 11, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THREE INSTANCES OF LEAKING AT THE FILTER AND ONE INSTANCE OF LEAKING FROM THE SIDE PORT OF THE TUBING OCCURRED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14983108 ↗
• MalfunctionJul 11, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT LEAKING AFFECTED THE MILRINONE PATIENTS. THREE INSTANCES OF LEAKING AT THE FILTER AND ONE INSTANCE OF LEAKING FROM THE SIDE PORT OF THE TUBING. THE CADD TUBING NUMBER IS 21-7343-24 AND THE LOT# IS 4232329. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14983024 ↗
• MalfunctionJul 6, 2022Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE TUBING DISCONNECTED AT THE HUB. THIS DISCONNECTION HAPPENED ON THREE DIFFERENT OCCASIONS WITH THE SAME PATIENT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14939769 ↗

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