CADD 21-7349-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 135 adverse event reports that list this exact device (DI 15019517184235), received between Sep 15, 2020 and May 12, 2026 — classified as 135 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (23 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 135 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Fluid/Blood Leak

  IT WAS REPORTED THE PCA TUBE IS LEAKING. THE EVENT OCCURRED DURING INFUSION, AND NO ADVERSE EFFECTS WERE REPORTED. POSSIBLE LOT NUMBER: 6037847.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25153176 ↗
• MalfunctionMay 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THAT THE CADD ADMIN SET WAS LEAKING. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25081498 ↗
• MalfunctionApr 16, 2026Air/Gas in Device

  IT WAS REPORTED THAT A BLINATUMOMAB PATIENT PRESENTING TO ED WITH BUBBLES THROUGHOUT THE CADD LINE, REQUIRING DISCONNECTION. THE REPORTER STATED THEY COULD CLEARLY SEE A LOT OF AIR THROUGHOUT THE LINE, IN PARTICULAR FROM THE BAG SPIKE TO WHERE IT ATTACHES TO THE CADD PUMP. THERE IS NO AIR IN THE INFUSION BAG. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24895943 ↗
• MalfunctionMar 25, 2026Air/Gas in Device

  IT WAS REPORTED THAT THERE WAS AIR WITHIN THE INFUSION OR LINE CAUSING THE INFUSION TO STOP. WHEN THE INFUSION WAS RELEASED FROM OUR ASEPTIC UNIT THERE WERE NO AIR BUBBLES INSIDE THE INFUSION BAG, OR THE LINE. IT WAS ALSO STATED THAT THIS PARTICULAR LINE HAD BEEN FAULTY IN THE PAST- USUALLY NOT RUNNING AT ALL RESULTING IN REPLACEMENT OF THE LINE WITH ANOTHER. THE PRODUCT SPECIFICALLY WAS BLINATUMOMAB. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691325 ↗
• MalfunctionMar 17, 2026Air/Gas in Device

  IT WAS REPORTED THAT AN AIR BUBBLE WAS OBSERVED IN THE CADD ADMINISTRATION SET FILTER. THERE WAS NO REPORTED PATIENT INVOLVEMENT. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24616686 ↗
• MalfunctionDec 10, 2025Failure to Infuse; Obstruction of Flow; Failure to Infuse; Obstruction of Flow

  IT WAS REPORTED THAT THE DEVICE HAD DOWNSTREAM OCCLUSION. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771581 ↗
• MalfunctionNov 19, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT THE MEDICATION DOES NOT PROPERLY CIRCULATE THROUGH THE TUBING, SO THEY NEEDED TO BE REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597295 ↗
• MalfunctionNov 18, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT THE MEDICATION DOES NOT PROPERLY CIRCULATE THROUGH THE TUBING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582400 ↗
• MalfunctionNov 18, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT THE MEDICATION DOES NOT PROPERLY CIRCULATE THROUGH THE TUBING, SO THEY NEEDED TO BE REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582387 ↗
• MalfunctionNov 18, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT THE MEDICATION DOES NOT PROPERLY CIRCULATE THROUGH THE TUBING, SO THEY NEEDED TO BE REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582382 ↗
• MalfunctionNov 18, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT THE MEDICATION DOES NOT PROPERLY CIRCULATE THROUGH THE TUBING, SO THEY NEEDED TO BE REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582378 ↗
• MalfunctionNov 18, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT THE MEDICATION DOES NOT PROPERLY CIRCULATE THROUGH THE TUBING, SO THEY NEEDED TO BE REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582336 ↗
• MalfunctionNov 18, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT THE MEDICATION DOES NOT PROPERLY CIRCULATE THROUGH THE TUBING, SO THEY NEEDED TO BE REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582331 ↗
• MalfunctionNov 18, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT THE MEDICATION DOES NOT PROPERLY CIRCULATE THROUGH THE TUBING, SO THEY NEEDED TO BE REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582330 ↗
• MalfunctionNov 18, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT THE MEDICATION DOES NOT PROPERLY CIRCULATE THROUGH THE TUBING, SO THEY NEEDED TO BE REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582327 ↗
• MalfunctionNov 18, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT THE MEDICATION DOES NOT PROPERLY CIRCULATE THROUGH THE TUBING, SO THEY NEEDED TO BE REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582320 ↗
• MalfunctionOct 20, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN DUE TO LITTLE TO NO FLOW OF THE MEDICATION FROM BAG INTO THE PATIENT'S EPIDURAL CATHETER. THERE WAS NO DOWNSTREAM OCCLUSION ALARM WITH THE CLAMP CLOSED. THE PATIENT HAD GOOD RELIEF FOR ABOUT 5 HOURS, PATIENT BECAME SIGNIFICANTLY MORE PAINFUL, BOLUS GIVEN FOR PATIENT PAIN 8/10, EPIDURAL PUMP BEGAN TO BEEP RESERVOIR VOLUME LOW, 6.1MLS NOTED TO BE LEFT ON PUMP. WHEN THEY WENT TO CHANGE THE BAG FROM THE PUMP THE BAG WAS VERY FULL, IT IS BELIEVED PATIENT RECEIVED VERY LOW EPIDURAL MEDICATION. IT APPEARS THE PUMP FUNCTIONED NORMALLY WHEN VIEWING THE HISTORY. THE PUMP WITH THE TUBING STILL IN PLACE AND NO CHANGES TO THE INFUSION AND THIS RESULTED IN NO FLOW OF THE DRUG FROM THE BAG TO THE END OF THE TUBING WITH NO ALARMS FROM THE PUMP IDENTIFYING ANY DOWNSTREAM OCCLUSIONS. WHEN THE CLAMP WAS RELEASED STILL RECEIVED NO FLOW OF FLUID IN THE TUBING AND NO ALARMS FIRED. REATTACHED ORIGINAL TUBING TO PUMP AND IT APPEARS TO DELIVER THE DOSE AND FUNCTIONED PROPERLY. THE FINAL VOLUME OF THE BAG WAS 50ML WHILE THE PUMP RESERVOIR LOW ALARM STATED THAT VOLUME TO BE AT 6.1ML. DIFFERENCE IN WHAT THE PUMP RECORDED AS INFUSED VERSES WHAT WAS ACTUALLY INF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23342197 ↗
• MalfunctionOct 20, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN DUE TO LITTLE TO NO FLOW OF THE MEDICATION FROM BAG INTO THE PATIENT'S EPIDURAL CATHETER. THERE WAS NO DOWNSTREAM OCCLUSION ALARM WITH THE CLAMP CLOSED. THE PATIENT HAD GOOD RELIEF FOR ABOUT 5 HOURS, PATIENT BECAME SIGNIFICANTLY MORE PAINFUL, BOLUS GIVEN FOR PATIENT PAIN 8/10, EPIDURAL PUMP BEGAN TO BEEP RESERVOIR VOLUME LOW, 6.1MLS NOTED TO BE LEFT ON PUMP. WHEN THEY WENT TO CHANGE THE BAG FROM THE PUMP THE BAG WAS VERY FULL, IT IS BELIEVED PATIENT RECEIVED VERY LOW EPIDURAL MEDICATION. IT APPEARS THE PUMP FUNCTIONED NORMALLY WHEN VIEWING THE HISTORY. THE PUMP WITH THE TUBING STILL IN PLACE AND NO CHANGES TO THE INFUSION AND THIS RESULTED IN NO FLOW OF THE DRUG FROM THE BAG TO THE END OF THE TUBING WITH NO ALARMS FROM THE PUMP IDENTIFYING ANY DOWNSTREAM OCCLUSIONS. WHEN THE CLAMP WAS RELEASED STILL RECEIVED NO FLOW OF FLUID IN THE TUBING AND NO ALARMS FIRED. REATTACHED ORIGINAL TUBING TO PUMP AND IT APPEARS TO DELIVER THE DOSE AND FUNCTIONED PROPERLY. THE FINAL VOLUME OF THE BAG WAS 50ML WHILE THE PUMP RESERVOIR LOW ALARM STATED THAT VOLUME TO BE AT 6.1ML. DIFFERENCE IN WHAT THE PUMP RECORDED AS INFUSED VERSES WHAT WAS ACTUALLY INF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23341725 ↗
• MalfunctionOct 20, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN DUE TO LITTLE TO NO FLOW OF THE MEDICATION FROM BAG INTO THE PATIENT'S EPIDURAL CATHETER. THERE WAS NO DOWNSTREAM OCCLUSION ALARM WITH THE CLAMP CLOSED. THE PATIENT HAD GOOD RELIEF FOR ABOUT 5 HOURS, PATIENT BECAME SIGNIFICANTLY MORE PAINFUL, BOLUS GIVEN FOR PATIENT PAIN 8/10, EPIDURAL PUMP BEGAN TO BEEP RESERVOIR VOLUME LOW, 6.1MLS NOTED TO BE LEFT ON PUMP. WHEN THEY WENT TO CHANGE THE BAG FROM THE PUMP THE BAG WAS VERY FULL, IT IS BELIEVED PATIENT RECEIVED VERY LOW EPIDURAL MEDICATION. IT APPEARS THE PUMP FUNCTIONED NORMALLY WHEN VIEWING THE HISTORY. THE PUMP WITH THE TUBING STILL IN PLACE AND NO CHANGES TO THE INFUSION AND THIS RESULTED IN NO FLOW OF THE DRUG FROM THE BAG TO THE END OF THE TUBING WITH NO ALARMS FROM THE PUMP IDENTIFYING ANY DOWNSTREAM OCCLUSIONS. WHEN THE CLAMP WAS RELEASED STILL RECEIVED NO FLOW OF FLUID IN THE TUBING AND NO ALARMS FIRED. REATTACHED ORIGINAL TUBING TO PUMP AND IT APPEARS TO DELIVER THE DOSE AND FUNCTIONED PROPERLY. THE FINAL VOLUME OF THE BAG WAS 50ML WHILE THE PUMP RESERVOIR LOW ALARM STATED THAT VOLUME TO BE AT 6.1ML. DIFFERENCE IN WHAT THE PUMP RECORDED AS INFUSED VERSES WHAT WAS ACTUALLY INF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23339644 ↗
• MalfunctionJul 4, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE DEVICE EXPERIENCED OCCLUSION DUE TO DEFECTIVE TUBING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22403601 ↗
• MalfunctionJun 25, 2025Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT SEVERAL TUBING SETS FROM ONE PARTICULAR LOT NUMBER DID NOT PRIME OR INFUSE MEDICATION. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22330644 ↗
• MalfunctionJun 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CASSETTE FOR THE TUBING CADD MACHINE WAS LEAKING. THE EVENT OCCURRED WHILE IN USE WITH PATIENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22204795 ↗
• MalfunctionMay 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A LEAKING FROM THE 0.2 MICRON FILTER. REPORTER STATED THAT IT WAS A SLOW LEAK, BUT THEY WERE ABLE TO IDENTIFY THE LEAKING BY USING AN ABSORBENT PAD. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026743 ↗
• MalfunctionMay 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A LEAKING FROM THE 0.2 MICRON FILTER. REPORTER STATED THAT IT WAS A SLOW LEAK, BUT THEY WERE ABLE TO IDENTIFY THE LEAKING BY USING AN ABSORBENT PAD. THERE WAS PATIENT INVOLVEMENT. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22018829 ↗
• MalfunctionDec 13, 2024Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE TUBING STOPPED DELIVERING EPIDURAL MEDICATION WHILE INSERTED INTO PATIENT. THEY TRIED ANOTHER TUBING WITH SAME LOT NUMBER AND THAT SET DID WORK BUT CAUSED THE PATIENT TO BE REINSERTED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926204 ↗

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