ICU Medical B9259Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00887709013292), received between May 4, 2020 and Apr 24, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (5 reports).

188 other recalls cover devices cleared under the same FDA submission (K964435); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2022Air/Gas in Device; Air/Gas in Device

  THE EVENT OCCURRED AROUND 10:00 AM AND INVOLVED A 17" (43 CM) APPX 5ML NON-DEHP EXT SET W/CLAVE®, 0.2 MICRON FILTER, CLAMP, ROTATING LUER. IT WAS REPORTED THAT DURING THE INDUCTION OF THE PATIENT THERE WAS A PRESENCE OF AIR BUBBLES DESPITE AN AIR VACUUM MADE RIGOROUSLY TO 2 INHALES. THE INHALO CLAMPED THE INTRAVENOUS TUBING AS SOON AS THEY SAW THE AIR BUBBLES PASS THROUGH THE FILTER SO THE PATIENT DID NOT GET ANY AIR. AFTER THE INHALO CLAMPED THE TUBING THEY TOOK AN EMPTY 10ML SYRINGE AND REMOVED ABOUT 4ML OF AIR, UNTIL THERE WAS A RETURN OF LIQUID WITHOUT AN AIR BUBBLE. ONCE ALL THE AIR BUBBLES WERE REMOVED, THE AIR BUBBLES NO LONGER PASSED THROUGH THE FILTER. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO REPORT OF PATIENT HARM. THIS CAPTURES THE FIFTH OF FIVE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14191188 ↗
• MalfunctionApr 24, 2022Air/Gas in Device; Air/Gas in Device

  THE EVENT OCCURRED AROUND 10:00 AM AND INVOLVED A 17" (43 CM) APPX 5ML NON-DEHP EXT SET W/CLAVE®, 0.2 MICRON FILTER, CLAMP, ROTATING LUER. IT WAS REPORTED THAT DURING THE INDUCTION OF THE PATIENT THERE WAS A PRESENCE OF AIR BUBBLES DESPITE AN AIR VACUUM MADE RIGOROUSLY TO 2 INHALES. THE INHALO CLAMPED THE INTRAVENOUS TUBING AS SOON AS THEY SAW THE AIR BUBBLES PASS THROUGH THE FILTER SO THE PATIENT DID NOT GET ANY AIR. AFTER THE INHALO CLAMPED THE TUBING THEY TOOK AN EMPTY 10ML SYRINGE AND REMOVED ABOUT 4ML OF AIR, UNTIL THERE WAS A RETURN OF LIQUID WITHOUT AN AIR BUBBLE. ONCE ALL THE AIR BUBBLES WERE REMOVED, THE AIR BUBBLES NO LONGER PASSED THROUGH THE FILTER. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO REPORT OF PATIENT HARM. THIS CAPTURES THE FOURTH OF FIVE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14191187 ↗
• MalfunctionApr 24, 2022Air/Gas in Device; Air/Gas in Device

  THE EVENT OCCURRED AROUND 10:00 AM AND INVOLVED A 17" (43 CM) APPX 5ML NON-DEHP EXT SET W/CLAVE®, 0.2 MICRON FILTER, CLAMP, ROTATING LUER. IT WAS REPORTED THAT DURING THE INDUCTION OF THE PATIENT THERE WAS A PRESENCE OF AIR BUBBLES DESPITE AN AIR VACUUM MADE RIGOROUSLY TO 2 INHALES. THE INHALO CLAMPED THE INTRAVENOUS TUBING AS SOON AS THEY SAW THE AIR BUBBLES PASS THROUGH THE FILTER SO THE PATIENT DID NOT GET ANY AIR. AFTER THE INHALO CLAMPED THE TUBING THEY TOOK AN EMPTY 10ML SYRINGE AND REMOVED ABOUT 4ML OF AIR, UNTIL THERE WAS A RETURN OF LIQUID WITHOUT AN AIR BUBBLE. ONCE ALL THE AIR BUBBLES WERE REMOVED, THE AIR BUBBLES NO LONGER PASSED THROUGH THE FILTER. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO REPORT OF PATIENT HARM. THIS CAPTURES THE THIRD OF FIVE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14191186 ↗
• MalfunctionApr 24, 2022Air/Gas in Device; Air/Gas in Device

  THE EVENT OCCURRED AROUND 10:00 AM AND INVOLVED A 17" (43 CM) APPX 5ML NON-DEHP EXT SET W/CLAVE®, 0.2 MICRON FILTER, CLAMP, ROTATING LUER. IT WAS REPORTED THAT DURING THE INDUCTION OF THE PATIENT THERE WAS A PRESENCE OF AIR BUBBLES DESPITE AN AIR VACUUM MADE RIGOROUSLY TO 2 INHALES. THE INHALO CLAMPED THE INTRAVENOUS TUBING AS SOON AS THEY SAW THE AIR BUBBLES PASS THROUGH THE FILTER SO THE PATIENT DID NOT GET ANY AIR. AFTER THE INHALO CLAMPED THE TUBING THEY TOOK AN EMPTY 10ML SYRINGE AND REMOVED ABOUT 4ML OF AIR, UNTIL THERE WAS A RETURN OF LIQUID WITHOUT AN AIR BUBBLE. ONCE ALL THE AIR BUBBLES WERE REMOVED, THE AIR BUBBLES NO LONGER PASSED THROUGH THE FILTER. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO REPORT OF PATIENT HARM. THIS CAPTURES THE SECOND OF FIVE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14191185 ↗
• MalfunctionApr 24, 2022Air/Gas in Device; Air/Gas in Device

  THE EVENT OCCURRED AROUND 10:00 AM AND INVOLVED A 17" (43 CM) APPX 5ML NON-DEHP EXT SET W/CLAVE®, 0.2 MICRON FILTER, CLAMP, ROTATING LUER. IT WAS REPORTED THAT DURING THE INDUCTION OF THE PATIENT THERE WAS A PRESENCE OF AIR BUBBLES DESPITE AN AIR VACUUM MADE RIGOROUSLY TO 2 INHALES. THE INHALO CLAMPED THE INTRAVENOUS TUBING AS SOON AS THEY SAW THE AIR BUBBLES PASS THROUGH THE FILTER SO THE PATIENT DID NOT GET ANY AIR. AFTER THE INHALO CLAMPED THE TUBING THEY TOOK AN EMPTY 10ML SYRINGE AND REMOVED ABOUT 4ML OF AIR, UNTIL THERE WAS A RETURN OF LIQUID WITHOUT AN AIR BUBBLE. ONCE ALL THE AIR BUBBLES WERE REMOVED, THE AIR BUBBLES NO LONGER PASSED THROUGH THE FILTER. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO REPORT OF PATIENT HARM. THIS CAPTURES THE FIRST OF FIVE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14191184 ↗
• MalfunctionMay 4, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNKNOWN DATE IN (B)(6) 2020 AND INVOLVED A 17¿ (43 CM) EXT SET W/CLAVE®, 0.2 MICRON FILTER, CLAMP, ROTATING LUER THAT LEAKED FROM THE FILTER DURING ADMINISTRATION OF TAXOL. THE CUSTOMER STATED THAT THE FILTER WAS PACKAGED WITHOUT A LITTLE QUILTED PIECE TO SAFELY CHECK IF THERE WAS DISCHARGE FROM THE FILTER AND INDEED THE QUILTED PIECE WAS WET AT THE END OF THE INFUSION. THE TUBING ASSEMBLY WAS DONE IN ACCORDANCE WITH OUT CARE METHOD, THAT IS, THE AIR WAS PURGED WITH THE B-BRAUN PUMP. THE EXTENSION SET WAS CONNECTED TO A SPACEPUMP IV TUBE SET BY B. BRAUN. THE CUSTOMER ALSO MENTIONED THAT THE PUMP WAS USED ON THE PATIENT AND THERE WAS NO CLEAR DEFECTS ON THE TUBING. THERE WAS PATIENT INVOLVEMENT BUT NO IMMEDIATE HARM TO THE PATIENT, BUT RISK FOR THE NURSE DUE TO EXPOSURE TO CYTOTOXIC PRODUCTS. THIS REPORT CAPTURES THE THIRD OF 3 EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10020155 ↗
• MalfunctionMay 4, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNKNOWN DATE IN (B)(6) 2020 AND INVOLVED A 17¿ (43 CM) EXT SET W/CLAVE®, 0.2 MICRON FILTER, CLAMP, ROTATING LUER THAT LEAKED FROM THE FILTER DURING ADMINISTRATION OF TAXOL. THE CUSTOMER STATED THAT THE FILTER WAS PACKAGED WITHOUT A LITTLE QUILTED PIECE TO SAFELY CHECK IF THERE WAS DISCHARGE FROM THE FILTER AND INDEED THE QUILTED PIECE WAS WET AT THE END OF THE INFUSION. THE TUBING ASSEMBLY WAS DONE IN ACCORDANCE WITH OUT CARE METHOD, THAT IS, THE AIR WAS PURGED WITH THE B-BRAUN PUMP. THE EXTENSION SET WAS CONNECTED TO A SPACEPUMP IV TUBE SET BY B. BRAUN. THE CUSTOMER ALSO MENTIONED THAT THE PUMP WAS USED ON THE PATIENT AND THERE WAS NO CLEAR DEFECTS ON THE TUBING. THERE WAS PATIENT INVOLVEMENT BUT NO IMMEDIATE HARM TO THE PATIENT, BUT RISK FOR THE NURSE DUE TO EXPOSURE TO CYTOTOXIC PRODUCTS. THIS REPORT CAPTURES THE SECOND OF 3 EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10020154 ↗
• MalfunctionMay 4, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVES A 17¿ (43 CM) EXT SET W/CLAVE®, 0.2 MICRON FILTER, CLAMP, ROTATING LUER THAT LEAKED FROM THE FILTER DURING ADMINISTRATION OF TAXOL. THE CUSTOMER STATED THAT THE FILTER WAS PACKAGED WITHOUT A LITTLE QUILTED PIECE TO SAFELY CHECK IF THERE WAS DISCHARGE FROM THE FILTER AND INDEED THE QUILTED PIECE WAS WET AT THE END OF THE INFUSION. THE TUBING ASSEMBLY WAS DONE IN ACCORDANCE WITH OUT CARE METHOD, THAT IS, THE AIR WAS PURGED WITH THE B-BRAUN PUMP. THE EXTENSION SET WAS CONNECTED TO A SPACEPUMP IV TUBE SET BY B. BRAUN. THE CUSTOMER ALSO MENTIONED THAT THE PUMP WAS USED ON THE PATIENT AND THERE WAS NO CLEAR DEFECTS ON THE TUBING. THERE WAS PATIENT INVOLVEMENT BUT NO IMMEDIATE HARM TO THE PATIENT, BUT RISK FOR THE NURSE DUE TO EXPOSURE TO CYTOTOXIC PRODUCTS. THIS REPORT CAPTURES THE FIRST OF 3 EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10020153 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K964435. One submission often covers many models, so check the product and lot details in each record.

• Z-3163-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• Z-3157-2026 · May 12, 2026 · Open, Classified
  IV Non-Dedicated Gravity Administration Sets with drip chambers
• Z-0154-2026 · Oct 2, 2025 · Open, Classified
  IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B
• Z-1721-2022 · Aug 1, 2022 · Open, Classified
  6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;
• Z-0958-2021 · Dec 2, 2020 · Terminated
  154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides ac
• Z-0955-2021 · Dec 2, 2020 · Terminated
  60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which pr
• Z-0957-2021 · Dec 2, 2020 · Terminated
  7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which pro
• Z-0956-2021 · Dec 2, 2020 · Terminated
  60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a singl
• Z-0185-2021 · Jul 6, 2020 · Terminated
  5 IN(13cm) APPX 0.87ml, EXT SET,NanoClave T-CONNECTOR; 1 unit per pouch, 50 pouches per case; UDI: (01)10887709052809(17)250101(30)50(10)4599980.
• Z-0240-2021 · Jul 6, 2020 · Terminated
  11 IN(28cm)APPX 0.97ml,SMALLBORE SET,NanoClave,6-PORT NanoClave MANIFOLD,BCV.1 unit per pouch, 50 pouches per case. UDI:(01)10887709088354(17)250101(30)50(10)4557643. The Intrava
• Z-0230-2021 · Jul 6, 2020 · Terminated
  114" (290 cm) 60 Drop 150ml Burette Set (Clave, Shut Off, Filter) w/4 Clave Remv 3-Port NanoClave Manifold, 2 Check Valves, Rotating Luer, 2 Exts. 1 unit per pouch, 25 pouches per
• Z-0186-2021 · Jul 6, 2020 · Terminated
  7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051048(17)250101(30)
• Z-0218-2021 · Jul 6, 2020 · Terminated
  126" (320 cm) 16.4 ml, 15 Drop Primary Set w/2 MicroClave Clear, Remv 2 Gang 4-Way NanoClave Stopcock, Rotating Luer, 1 Ext; 1 unit per pouch, 50 multivac pouches per case. UDI:(01
• Z-0255-2021 · Jul 6, 2020 · Terminated
  148 IN (376cm) APPX 18.8 ml, 15 DROP SET, 2 CLAVE, Remv 3 Gang Clave Stopcock.1 unit per pouch, 25 pouches per case. UDI:(01)10887709071558(17)250101(30)25(10)4603841. The Intrav
• Z-0258-2021 · Jul 6, 2020 · Terminated
  112" (284 cm) 60 Drop 150ml Burette Set (Clave, Shut-Off) w/2 MicroClave, Remv 3 Gang 4-Way Clave Stopcock, Check Valve, Rotating Luer, 1 Ext. 1 unit per pouch, 25 pouches per case

…and 173 more.