CADD 21-7411-51Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,858 adverse event reports that list this exact device (DI 10610586029554), received between Apr 12, 2017 and Sep 8, 2026 — classified as 1 death, 39 injuries, 1,818 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (456 reports).

2 other recalls cover devices cleared under the same FDA submission (K051568); 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 1,858 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50676992 ↗
• MalfunctionJun 8, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PUMP DELIVERED ONLY 1 ML SINCE BEING STARTED THE PREVIOUS DAY, WITH THE RECORDED VOLUME DECREASING FROM 2700 TO 2144. UPON WAKING IN THE MORNING, THE PATIENT¿S FACE APPEARED CLEAR, WHEREAS IT WAS TYPICALLY RED DUE TO THE MEDICATION; HOWEVER, THE PATIENT REPORTED FEELING FINE. THE EVENT OCCURRED DURING CONTINUOUS INFUSION. THERE WAS PATIENT INVOLVEMENT, AND NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25430592 ↗
• MalfunctionApr 30, 2026Crack

  THE DEVICE EVALUATION NOTED A CRACKED DOWNSTREAM OCCLUSION ALARM. THIS EVENT OCCURRED DURING ROUTINE PREVENTIVE MAINTENANCE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25048917 ↗
• MalfunctionApr 7, 2026Failure to Infuse

  IT WAS REPORTED THAT THE PUMP RECEIVED ERROR CODE 46876 WITH RED SCREEN AND SYMBOLS, AND ¿REMOVE AND REATTACH CASSETTE¿ MESSAGE HAD APPEARED. IT WAS FURTHER REPORTED THAT PATIENT DATA AND SETTINGS WERE LOST, AND THE PUMP ALARMED WITH THREE SEPARATE ERROR CODES BEFORE EVENTUALLY WIPING ALL SETTINGS. THE EVENT OCCURRED DURING INFUSION, WITH NO HARM REPORTED. IT TOOK PLACE AT THE PATIENT¿S HOME, AND THE DEVICE WAS OPERATED BY A HEALTHCARE PROFESSIONAL. THE MEDICATION INVOLVED DURING INFUSION WAS FLUOROURACIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800767 ↗
• MalfunctionApr 3, 2026Failure to Infuse

  THE DEVICE EVALUATION NOTED A MOTOR RATE ERROR. THE EVENT OCCURRED DURING TESTING, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24779517 ↗
• MalfunctionMar 26, 2026Material Separation

  IT WAS REPORTED THAT DURING TESTING THE PUMP HAD A DETACHED DSO SEAL. THERE WERE NO PATIENT INVOLVEMENT AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24705853 ↗
• MalfunctionMar 26, 2026Device Alarm System

  IT WAS REPORTED THAT DEVICE HAD BEEN UNDERGOING INFUSION THERAPY FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION WITH REMODULIN (TREPROSTINIL). PATIENT REPORTED PUMP ALARMS AND ATTEMPTED MULTIPLE RELOADS AND RESTARTS, BUT ALARMS RECURRED. PATIENT DELAYED REPORTING, THINKING IT MIGHT BE HER FAULT. LATER, NOTED CLEAR THREADS ON PUMP WERE BROKEN AND INTERMITTENTLY BLOOD VISIBLE IN THE LINE. PUMP HISTORY SHOWED ONLY 0.5 ML REMODULIN INFUSED OVER 2.5 DAYS AT RATE OF 0.034 ML PER HR. PATIENT REPORTED NO NOTICEABLE CHANGES IN CONDITION. CLINIC RN ADJUSTED HER INFUSION RATE TO SLOWLY TITRATE HER BACK TO FULL DOSE TO PREVENT ADVERSE EVENT. EVENT OCCURRED DURING WHILE IN USE WITH PATIENT AND OPERATOR OF DEVICE WAS PATIENT AND EVENT OCCUR AT PATIENT HOME. THERE WAS NO PATIENT INVOLVEMENT AND REPORTED NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24705774 ↗
• MalfunctionMar 6, 2026Material Split, Cut or Torn

  THE DEVICE EVALUATION NOTED A TORN DOWNSTREAM OCCLUSION SEAL. THE EVENT OCCURRED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT AND HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24532265 ↗
• MalfunctionMar 5, 2026Failure to Sense

  THE DEVICE EVALUATION REVEALED A LOOSE AIR DETECTOR. THE EVENT OCCURRED DURING TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519032 ↗
• MalfunctionMar 4, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING TESTING THE DEVICE HAD A RIPPED DOWNSTREAM OCCLUSION SEAL. THERE WERE NO PATIENT INVOLVEMENT AND PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24513275 ↗
• MalfunctionMar 4, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DEVICE HAS A RIPPED DOWNSTREAM OCCLUSION SEAL. THE EVENT OCCURRED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507130 ↗
• MalfunctionMar 2, 2026Crack

  IT WAS FOUND DURING INVESTIGATION OF A RETURNED PUMP THAT THE DOWNSTREAM OCCLUSION (DSO) SEAL HAS CRACKS ON IT. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482652 ↗
• MalfunctionFeb 16, 2026Increase in Pressure

  IT WAS REPORTED THAT AN 'OVERPRESSURE' ERROR MESSAGE APPEARED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24349361 ↗
• MalfunctionFeb 16, 2026Failure to Infuse

  IT WAS REPORTED THAT THE PUMP HAD ALARMED NO DISPOSABLE CLAMP TUBING. THE PUMP HAD BEEN STOPPED. THE PUMP SETTINGS HAD BEEN REVIEWED, AND THE DEVICE HAD BEEN POWERED OFF. THE LINE HAD BEEN CLAMPED NEAR THE PORT. RESERVOIR VOLUME WAS RECORDED AS 229.5 ML, WITH A RATE OF 2.6 ML PER HOUR. A TOTAL OF 18.75 ML HAD BEEN DELIVERED. THE PATIENT WAS NOT AFFECTED. THE EVENT OCCURRED WHILE IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344417 ↗
• MalfunctionJan 15, 2026Disconnection

  IT WAS REPORTED THAT THE PATIENT'S BROTHER OBSERVED THAT THE CASSETTE WAS COMPLETELY DETACHED FROM THE PUMP. THE PATIENT STATED THEY WERE UNAWARE OF HOW THE CASSETTE BECAME DETACHED AND DID NOT RECALL THE PUMP ALARMING. THE CASSETTE WAS REATTACHED, THE PUMP WAS POWERED ON, AND THE SETTINGS WERE REVIEWED. FOR PATIENT SAFETY, THE PUMP WAS THEN POWERED OFF. THE PATIENT HAD A DISCONNECT APPOINTMENT SCHEDULED FOR THE FOLLOWING DAY; HOWEVER, THE PUMP APPEARED TO HAVE BEEN POWERED OFF SINCE MONDAY. THE INFUSION WAS INITIATED ON (B)(6) 2025 AT APPROXIMATELY 4:30 PM, AND THE SCREEN INDICATED ¿EMPTY IN 119 HOURS 15 MINUTES¿ (120 HOURS TOTAL PER MEDICATION LABEL). THERE WERE A PATIENT INVOLVEMENT AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24080718 ↗
• MalfunctionJan 15, 2026Device Sensing Problem

  A NO DISPOSABLE ALARM (NDA) WAS REPORTED WITH NO PATIENT AFFECTED. DEVICE SETTINGS WERE REVIEWED; HOWEVER, THE ALARM CONDITION PERSISTED. THE CALLER REPORTED THAT THE CLAMPS AND CONNECTORS WERE TAPED, AND CLOSING THE CLAMP COULD CAUSE THE TUBING TO DISCONNECT. THE PUMP WAS POWERED OFF. THE EVENT OCCURRED IN PATIENT'S HOME, AND THE OPERATOR WAS HEALTHCARE PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24080051 ↗
• MalfunctionDec 29, 2025Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE PUMP DISPLAYED AN ERROR CODE STATING THE MOTOR WAS NOT RUNNING. THE DEVICE EVALUATION NOTED A MOTOR NOT RUNNING ERROR. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23918917 ↗
• MalfunctionDec 29, 2025Loose or Intermittent Connection; Mechanical Problem; Loose or Intermittent Connection; Mechanical Problem

  FOUND THE UNIT¿S BATTERY DOOR WAS DAMAGED AND THE RELIEF ALARM PRESSURE KNOB IS BROKEN AND BOTH REQUIRE REPLACEMENT. DURING EVALUATION, THE UNIT FAILED TIDAL VOLUME. TROUBLESHOT ISSUE AND FOUND THAT THE TIDAL VOLUME KNOB WILL ROTATE PAST THE END SET POINTS ON THE HIGH AND LOW ENDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23908605 ↗
• MalfunctionDec 23, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT DURING THE INFUSION, THE PATIENT CONTACTED THE CARE TEAM TO REPORT THAT THE PUMP ADMINISTERING REMODULIN DISPLAYED A ¿SYSTEM FAULT¿ ALARM. THE PATIENT PROMPTLY TRANSITIONED TO HER BACKUP PUMP TO ENSURE UNINTERRUPTED INFUSION. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878802 ↗
• MalfunctionDec 9, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THE PUMP DID NOT CALIBRATED CORRECTLY. IT WAS REPORTED THAT ON 2 OCCASIONS, INCLUDING (B)(6) 2025, NUMBNESS OF THE HANDS AND FEET, DIZZINESS, ABSENCE OF USUAL FACIAL FLUSHING WITH REMODULING, AND GENERAL MALAISE HAD BEEN EXPERIENCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23760771 ↗
• MalfunctionDec 8, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED HE PUMP NOT CALIBRATED CORRECTLY. IT WAS REPORTED THAT ON 2 OCCASIONS, INCLUDING ON (B)(6) 2025, NUMBNESS OF THE HANDS AND FEET, DIZZINESS, ABSENCE OF USUAL FACIAL FLUSHING WITH REMODULIN, AND GENERAL MALAISE HAD BEEN EXPERIENCED. THE PUMP WAS SWITCHED TO A BACKUP UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23745556 ↗
• MalfunctionDec 5, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE DEVICE GAVE ERROR CODE 41622 AND RED SCREEN WHILE PRIMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23730391 ↗
• MalfunctionNov 25, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE PUMP HAD ALARMED DOWNSTREAM OCCLUSION. THE PATIENT HAD NOT BEEN MEDICALLY AFFECTED. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE PATIENT'S HOME AND THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646015 ↗
• MalfunctionNov 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PUMP HAD A DOWNSTREAM OCCLUSION SEAL THAT WAS DETACHED DURING TESTING. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23623770 ↗
• MalfunctionOct 23, 2025Device Sensing Problem; Device Sensing Problem

  THE DEVICE EVALUATION NOTED A DAMAGED UPSTREAM OCCLUSION SENSOR AND SEAL. THE EVENT OCCURRED DURING TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367702 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051568. One submission often covers many models, so check the product and lot details in each record.

• Z-1621-2008 · Mar 7, 2008 · Terminated
  CADD-MS 3 Ambulatory Infusion Pump, Model 7400 Smiths Medical MD, Inc., St. Paul, MN 55112 USA. Electromechanical pumps used for general drug delivery infusion therapies. Used m
• Z-1641-2008 · Feb 22, 2008 · Terminated
  CADD-MS"3 Ambulatory Infusion Pumps, Model 7400, Rx only, CE 0473, SN 499000. The device is designed for subcutaneous, intravenous, epidural and intrathecal infusion of medicatio