CADD 21-7081-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10610586021480), received between Aug 9, 2017 and May 6, 2022 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (19 reports).

32 other recalls cover devices cleared under the same FDA submission (K991599); 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.

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.

• MalfunctionMay 6, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PART OF THE SEPTUM WAS DEFECTIVE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14310982 ↗
• MalfunctionJan 24, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED INDICATING THAT PRIOR TO USE OF THIS SMITHS MEDICAL CADD ADMINISTRATION SETS, LEAKING WAS NOTICED FROM THE RUBBER PLACED ON THE Y DEVIATION. IT WAS REPORTED THAT FAULT DIDN'T OCCUR WHILE IN USE WITH A PATIENT. NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9628813 ↗
• MalfunctionJan 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED INDICATING THAT DURING USE OF A SMITHS MEDICAL CADD ADMINISTRATION SET, THE PATIENT FOUND THAT THE INFUSION LINE WAS LEAKING FROM THE STINGING CAP OF THE Y. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9622374 ↗
• MalfunctionJan 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED INDICATING THAT DURING USE OF A SMITHS MEDICAL CADD ADMINISTRATION SET, THE PATIENT FOUND THAT THE INFUSION LINE WAS LEAKING FROM THE STINGING CAP OF THE Y. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9622364 ↗
• MalfunctionJan 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED INDICATING THAT DURING USE OF A SMITHS MEDICAL CADD ADMINISTRATION SET, THE PATIENT FOUND THAT THE INFUSION LINE WAS LEAKING FROM THE STINGING CAP OF THE Y. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9622362 ↗
• MalfunctionNov 26, 2019Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED INDICATING THAT DURING INFUSION, A SMITHS MEDICAL CADD ADMINISTRATION SET WAS LEAKING FROM THE STINGING CAP OF THE Y. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9378139 ↗
• MalfunctionNov 14, 2019Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED INDICATING THAT THE CADD ADMINISTRATION SET LEAKED . THE LEAK WAS NOTICED FROM THE STINGING CAP OF THE "Y". THE NUMBER OF UNITS INVOLVED WAS REPORTED TO BE ONE. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9323753 ↗
• MalfunctionNov 7, 2019Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED INDICATING THAT THE CADD ADMINISTRATION SET LEAKED WAS FOUND LEAKING DURING INFUSION. THE LEAK WAS NOTICED FROM THE STINGING CAP OF THE "Y". THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9292723 ↗
• MalfunctionNov 7, 2019Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED INDICATING THAT THE CADD ADMINISTRATION SET LEAKED WAS FOUND LEAKING DURING INFUSION. THE LEAK WAS NOTICED FROM THE STINGING CAP OF THE "Y". THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9292722 ↗
• MalfunctionNov 7, 2019Fluid/Blood Leak; Fluid/Blood Leak

  INVESTIGATION RESULTS COMPLETED ON A SMITHS MEDICAL AMBULATORY INFUSION PUMPS/CADD ADMINISTRATION SETS - NON FLOW STOP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9292715 ↗
• MalfunctionNov 7, 2019Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED INDICATING THAT THE CADD ADMINISTRATION SET LEAKED WAS FOUND LEAKING DURING INFUSION. THE LEAK WAS NOTICED FROM THE STINGING CAP OF THE "Y". THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9292710 ↗
• MalfunctionNov 7, 2019Fluid/Blood Leak; Fluid/Blood Leak

  INVESTIGATION RESULTS COMPLETED ON A SMITHS MEDICAL AMBULATORY INFUSION PUMPS/CADD ADMINISTRATION SETS - NON FLOW STOP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9292708 ↗
• MalfunctionNov 7, 2019Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED INDICATING THAT THE CADD ADMINISTRATION SET LEAKED WAS FOUND LEAKING DURING INFUSION. THE LEAK WAS NOTICED FROM THE STINGING CAP OF THE "Y". THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9292707 ↗
• MalfunctionNov 7, 2019Fluid/Blood Leak; Fluid/Blood Leak

  INVESTIGATION RESULTS COMPLETED ON A SMITHS MEDICAL AMBULATORY INFUSION PUMPS/CADD ADMINISTRATION SETS - NON FLOW STOP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9292706 ↗
• MalfunctionNov 5, 2019Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED INDICATING THAT THE CADD ADMINISTRATION SET LEAKED WAS FOUND LEAKING DURING INFUSION. THE LEAK WAS NOTICED FROM THE STINGING CAP OF THE "Y". THE NUMBER OF UNITS INVOLVED WERE NOT SPECIFIED. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9282180 ↗
• MalfunctionNov 5, 2019Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED INDICATING THAT THE CADD ADMINISTRATION SET LEAKED WAS FOUND LEAKING DURING INFUSION. THE LEAK WAS NOTICED FROM THE STINGING CAP OF THE "Y". THE NUMBER OF UNITS INVOLVED WERE NOT SPECIFIED. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9282178 ↗
• MalfunctionSep 24, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  INFORMATION RECEIVED THAT A SMITHS MEDICAL PRODUCT THE CADD® HIGH-VOLUME ADMINISTRATION SETS, HAD LEAKAGE DURING INFUSION OF UNKNOWN MEDICATION. THE LEAKAGE OCCURRED AT THE BRANCH SITE THAT IS MARKED WITH A BLACK PEN. NO ADVERSE PATIENT INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9111232 ↗
• MalfunctionSep 24, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  INFORMATION RECEIVED THAT A SMITHS MEDICAL PRODUCT THE CADD® HIGH-VOLUME ADMINISTRATION SETS, HAD LEAKAGE DURING INFUSION OF UNKNOWN MEDICATION. THE LEAKAGE OCCURRED AT THE BRANCH SITE THAT IS MARKED WITH A BLACK PEN. NO ADVERSE PATIENT INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9111227 ↗
• MalfunctionSep 24, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  INFORMATION RECEIVED THAT A SMITHS MEDICAL PRODUCT THE CADD® HIGH-VOLUME ADMINISTRATION SETS, HAD LEAKAGE DURING INFUSION OF UNKNOWN MEDICATION. THE LEAKAGE OCCURRED AT THE BRANCH SITE THAT IS MARKED WITH A BLACK PEN. NO ADVERSE PATIENT INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9111223 ↗
• MalfunctionDec 7, 2018Infusion or Flow Problem; Infusion or Flow Problem

  INFORMATION WAS RECEIVED THAT THIS SMITHS MEDICAL CADD ADMINISTRATION SETS ANTI-SIPHON VALVE LOSES AND THE PUMP ALARMED. NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8143313 ↗
• MalfunctionAug 9, 2017Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO HOURS INTO INFUSION, A LEAKAGE WAS OBSERVED FROM A CADD¿ HIGH-VOLUME ADMINISTRATION SET. THE LEAKAGE WAS OBSERVED IN THE PUMP "WHERE THERE WAS THE AIR SENSOR IN THE OLD VERSION OF THE PUMP, THAT IS WHERE THE INFUSOR IS THIN". THE PATIENT'S BACKPACK WAS DRENCHED AND THE LIQUID WAS SPILLING OUT OF THE SET. THE "BABY" WAS DETACHED IMMEDIATELY AND A NEW SET WAS PLACED. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6776950 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K991599. One submission often covers many models, so check the product and lot details in each record.

• Z-0659-06 · Dec 8, 2005 · Terminated
  Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps. ------Model Number RC4106 (Reorder No. 21-0402-25) Primary Administr
• Z-0660-06 · Dec 8, 2005 · Terminated
  Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps. Model Number 8C290 (Reorder No. 21-0304-01) Speciality Administrat
• Z-0658-06 · Dec 8, 2005 · Terminated
  Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps.---- Model Number CC1301 (Reorder No. 21-0334-01) Primary Checkvalve
• Z-0470-05 · Dec 3, 2004 · Terminated
  Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number CC2102 (Reorder No. 21-0309-01) 112 i
• Z-0466-05 · Dec 3, 2004 · Terminated
  Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. 3 Model Numbers are used for this same Burette Adm
• Z-0485-05 · Dec 3, 2004 · Terminated
  Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number NJ2304 (Reorder No. 21-0433-01) Buret
• Z-0480-05 · Dec 3, 2004 · Terminated
  Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number CF4203 (Reorder No. 21-0340-01) 105 i
• Z-0492-05 · Dec 3, 2004 · Terminated
  Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number RC1201 (Reorder No. 21-0442-25) Prima
• Z-0486-05 · Dec 3, 2004 · Terminated
  Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number 8C4209 (Reorder No. 21-0327-01) Prima
• Z-0478-05 · Dec 3, 2004 · Terminated
  Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number CC3217 (Reorder No. 21-0338-01) Speci
• Z-0490-05 · Dec 3, 2004 · Terminated
  Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number RC4106 (Reorder No. 21-0402-25) Prima
• Z-0476-05 · Dec 3, 2004 · Terminated
  Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number CC1301 (Reorder No. 21-0334-01) Prima
• Z-0468-05 · Dec 3, 2004 · Terminated
  Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. 2 Model Numbers are used for this same Burette Adm
• Z-0487-05 · Dec 3, 2004 · Terminated
  Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number I8C820 (Reorder No. 21-0346-25) Prima
• Z-0481-05 · Dec 3, 2004 · Terminated
  Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number LC4203 (Reorder No. 21-0341-01) 105 i

…and 17 more.