ICU Medical B1181Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887709000667), received between Mar 13, 2020 and Mar 13, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED A 8" EXT SET, 0.2 MICRON FILTER LEAKED DURING 24 HOUR INFUSION OF CHEMOTHERAPY. THE FILTER WAS PLACED AT 11:05 ON (B)(6) 2020 AND THE LEAK WAS NOTICED AT 20:15 ON (B)(6) 2020. THE CHEMOTHERAPY MEDICATIONS WERE DOXORUBICIN, ETOPOSIDE, AND VINCRISTINE. THE SITE OF THE LEAK WAS AROUND THE CIRCLE PIECE OF THE FILTER. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM REPORTED. THE NURSING STAFF WERE AWARE OF THE RISK OF THE FILTER LEAKING AND PUT PLASTIC BETWEEN THE PATIENT'S SKIN AND THE FILTER. THE CUSTOMER REPORTED NO ALARMS WERE GOING OFF/ON THE UNSPECIFIED IV PUMP DURING THE EVENT. THE PUMP WAS SET TO ALARM AT 6 PSI (POUNDS PER SQUARE INCH).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9829861 ↗
• MalfunctionMar 13, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED A 8" EXT SET, 0.2 MICRON FILTER LEAKED DURING 24 HOUR INFUSION OF CHEMOTHERAPY OF DOXORUBICIN, ETOPOSIDE, AND VINCRISTINE. THE SITE OF THE LEAK WAS AROUND THE CIRCLE PIECE OF THE FILTER, A PINPOINT DROP WAS NOTED. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM REPORTED. THE NURSING STAFF WERE AWARE OF THE RISK OF THE FILTER LEAKING AND PUT PLASTIC BETWEEN THE PATIENT'S SKIN AND THE FILTER. THE CUSTOMER REPORTED NO ALARMS WERE GOING OFF/ON THE UNSPECIFIED IV PUMP DURING THE EVENT. THE PUMP WAS SET TO ALARM AT 6 PSI (POUNDS PER SQUARE INCH).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9829465 ↗
• MalfunctionMar 13, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED A 8" EXT SET, 0.2 MICRON FILTER LEAKED DURING 24 HOUR INFUSION OF CHEMOTHERAPY OF DOXORUBICIN, ETOPOSIDE, AND VINCRISTINE. THE SITE OF THE LEAK WAS AROUND THE CIRCLE PIECE OF THE FILTER, A PINPOINT DROP WAS NOTED. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM REPORTED. THE NURSING STAFF WERE AWARE OF THE RISK OF THE FILTER LEAKING AND PUT PLASTIC BETWEEN THE PATIENT'S SKIN AND THE FILTER. THE CUSTOMER REPORTED NO ALARMS WERE GOING OFF/ON THE UNSPECIFIED IV PUMP DURING THE EVENT. THE PUMP WAS SET TO ALARM AT 6 PSI (POUNDS PER SQUARE INCH).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9829458 ↗

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-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-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-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-0243-2021 · Jul 6, 2020 · Terminated
  78" (198 cm) APPX 1.7ml, EXT SET, MicroClave Clear, 6-PORT NanoClave MANIFOLD, FILTER .1 unit per pouch, 50 pouches per case. UDI:(01)10887709121703(17)250201(30)50(10)4723226.
• Z-0222-2021 · Jul 6, 2020 · Terminated
  123 IN (312cm) APPX 16.1 ml, 10 DROP SET w/3 MicroClave, 3-Port NanoClave; UDI:(01)10887709085432(17)241201(30)25(10)4536733;(01)10887709085432(17)250101(30)25(10)4573641. The In
• Z-0235-2021 · Jul 6, 2020 · Terminated
  10 IN (25cm) APPX 1.5ml EXT w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709067322(17)250101(30)50(10)4565730; (01)10887709067322(
• Z-0249-2021 · Jul 6, 2020 · Terminated
  6 IN (15 cm) Ext Set, MicroClave Clear, T-Connector, RLL, Approx PV: 0.86 mL.1 unit per pouch, 50 pouches per case. UDI:(01)10887709079877(17)250101(30)50(10)4584753;(01)108877090
• Z-0205-2021 · Jul 6, 2020 · Terminated
  9.5" (24 cm) Appx 0.56 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Luer Lock; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709080703(17)250101(30)5
• Z-0256-2021 · Jul 6, 2020 · Terminated
  149 IN (378cm) APPX 19.1 ml, 15 DROP SET, 3 Clave, REMV 3 GANG 4-WAY Clave STOPCOCK 2 EXT. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709074696(17)250101(30)25(10)4711277;
• Z-0216-2021 · Jul 6, 2020 · Terminated
  54 IN (137 cm) APPX 7.2 ml EXT SET w NanoClave 4-Way Stopcock ;UDI:(01)10840619082526(17)250201(30)50(10)4718579. The Intravascular Administration Set is a single use, sterile, n

…and 173 more.