ICU Medical MC9079Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00887709078161), received between Nov 3, 2020 and Apr 5, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2021Air/Gas in Device; Air/Gas in Device

  A MEDSUN MANDATORY MEDWATCH REPORT WAS RECEIVED THAT STATED "A LOT OF AIR FOUND BETWEEN POINTY END OF FILTER AND TUBING. PATIENT'S PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE TUBING HAS BEEN HAVING ISSUES WITH AIR BUBBLES FOR THE PAST FEW DAYS. TROUBLESHOOTING BY RN TRANSPORT SPECIALIST (RNTS) 2 DAYS AGO AND IV PUMP WAS CHANGED. NO LEAKS OR BREAK IN LINE. CHAMBER NOTED TO BE FULL, RN EMPTIED HALF OF CHAMBER AND WAS ABLE TO FLICK ALL OF THE AIR BUBBLES UP TOWARDS CHAMBER. CONSIDER USE OF DIFFERENT TUBING IF AVAILABLE. PART OF LARGER AIR IN LINE TREND. THIS AIR SEEMS LOWER THAN OTHERS REPORTED AND MAY BE MORE ASSOCIATED WITH DEFECTIVE FILTER - THIS PATIENT HAS ALSO HAD REPEATED BLOOD BACK UP ISSUES THAT ARE BELIEVED TO BE ASSOCIATED WITH A FILTER PROBLEM¿. THE EVENT OCCURRED IN THE PATIENT'S ROOM AT THE HOSPITAL. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11615894 ↗
• MalfunctionMar 10, 2021Air/Gas in Device; Air/Gas in Device

  ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: ¿IT WAS REPORTED THAT THE AIR WAS NOT BEING DETECTED IN THE PUMP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11454445 ↗
• MalfunctionFeb 2, 2021Infusion or Flow Problem; Infusion or Flow Problem

  A USER FACILITY MANDATORY MEDWATCH WAS RECEIVED THAT STATED, ¿PATIENT WITH A SINGLE LUMEN PICC LINE WAS FOUND TO HAVE AIR IN LINE A TOTAL OF 5 TIMES DURING THE 12 HOUR SHIFT, AND WAS FOUND TO HAVE BLOOD BACKED UP IN LINE FOR A TOTAL OF 2 TIMES. BOTH THE AIR AND THE BLOOD WERE ABLE TO BE CLEARED FROM THE LINE WITHOUT THE NEED TO OPEN THE LINE TO THE PATIENT.¿  ADDITIONALLY, THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN (B)(6) 2020 IN THE PATIENT¿S ROOM AT THE HOSPITAL. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11267471 ↗
• MalfunctionNov 5, 2020Infusion or Flow Problem; Infusion or Flow Problem

  THE CUSTOMER REPORTED A 17" EXT SET W/0.2 MICRON FILTER, MICROCLAVE® CLEAR, CLAMP, ROTATING LUER THAT HAD AIR IN THE IV TUBING WHEN CHANGING OUT THE LINES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10790770 ↗
• MalfunctionNov 3, 2020Infusion or Flow Problem; Infusion or Flow Problem

  USER FACILITY MEDWATCH REPORT WAS RECEIVED AND STATED THE FOLLOWING: AIR BUBBLES PRESENT BETWEEN FILTER AND PATIENT. I WAS CHANGING HAL (HYPERALIMENTATION) AND IL (INTRAVENOUS) LINES INFUSING THROUGH A PICC LINE. I HAD PRIMED THE TUBING, CHECKED FOR AND DISPELLED AIR BUBBLES IN THE LINE. ONCE THE LINE WAS ATTACHED TO THE PATIENT, AIR BUBBLES DEVELOPED BETWEEN THE FILTER AND THE PATIENT. THE INFUSION WAS IMMEDIATELY STOPPED, A NEW FILTER WAS PRIMED AND REATTACHED TO THE PATIENT. AGAIN AIR BUBBLES APPEARED IN THE SAME AREA OF THE LINE. ANOTHER RN THEN PRIMED A WHOLE NEW LINE, NO FURTHER AIR BUBBLES NOTED. THE REMAINING STOCK OF FILTERS OF THAT LOT NUMBER WERE PULLED FOR TESTING. THE ORIGINAL INTENDED PROCEDURE WAS IV INFUSION. THE PROBLEM THAT THE USER HAVE WAS DEVICE FAILURE (E.G. BROKE, COULDN¿T GET IT TO WORK OR STOPPED WORKING). THERE WAS PATIENT INVOLVEMENT, BUT NO HARM REPORTED. THIS REPORT IS FOR THE FIRST OF TWO DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10777105 ↗
• MalfunctionNov 3, 2020Infusion or Flow Problem; Infusion or Flow Problem

  USER FACILITY MEDWATCH REPORT WAS RECEIVED AND STATED THE FOLLOWING: AIR BUBBLES PRESENT BETWEEN FILTER AND PATIENT. I WAS CHANGING HAL (HYPERALIMENTATION) AND IL (INTRAVENOUS) LINES INFUSING THROUGH A PICC LINE. I HAD PRIMED THE TUBING, CHECKED FOR AND DISPELLED AIR BUBBLES IN THE LINE. ONCE THE LINE WAS ATTACHED TO THE PATIENT, AIR BUBBLES DEVELOPED BETWEEN THE FILTER AND THE PATIENT. THE INFUSION WAS IMMEDIATELY STOPPED, A NEW FILTER WAS PRIMED AND REATTACHED TO THE PATIENT. AGAIN AIR BUBBLES APPEARED IN THE SAME AREA OF THE LINE. ANOTHER RN THEN PRIMED A WHOLE NEW LINE, NO FURTHER AIR BUBBLES NOTED. THE REMAINING STOCK OF FILTERS OF THAT LOT NUMBER WERE PULLED FOR TESTING. THE ORIGINAL INTENDED PROCEDURE WAS IV INFUSION. THE PROBLEM THAT THE USER HAVE WAS DEVICE FAILURE (E.G. BROKE, COULDN¿T GET IT TO WORK OR STOPPED WORKING). THERE WAS PATIENT INVOLVEMENT BUT NO HARM REPORTED. THIS REPORT IS FOR THE SECOND OF TWO DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10777104 ↗

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-3157-2026 · May 12, 2026 · Open, Classified
  IV Non-Dedicated Gravity Administration Sets with drip chambers
• Z-3163-2026 · May 12, 2026 · Open, Classified
  IV 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-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-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-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-0211-2021 · Jul 6, 2020 · Terminated
  5.5" (14 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 MicroClave" Clear, NanoClave" T-Connector, 3 Clamps, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case.UDI:(01)
• 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-0194-2021 · Jul 6, 2020 · Terminated
  7" (18 cm) Appx 0.25 ml, Smallbore Ext Set w/Remv NanoClave, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709065069(17)250101(30)50(10)4590843;(0
• Z-0183-2021 · Jul 6, 2020 · Terminated
  6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave T-Connector, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case; UDI:(01)10887709051024(17)250101(30)50(10)
• Z-0219-2021 · Jul 6, 2020 · Terminated
  113" (287 cm) Appx 14.7 ml, 10 Drop Admin Set w/MicroClave" Clear, Remv 4-Way NanoClave" Stopcock, Remv 2-Gang 4-Way NanoClave" Stopcocks, Spin Luer w/ Filter Cap, 2 Ext.1 unit per
• Z-0239-2021 · Jul 6, 2020 · Terminated
  APPX 0.75 ml, 6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709070551(17)241201(30)50(10)4542066; (01)10887709070551(17)241201(30)50(1
• Z-0247-2021 · Jul 6, 2020 · Terminated
  7 IN (18CM) APPX 0.26ml, SMALLBORE EXT SET, MicroClave, Clave T-Connector.1 unit per pouch, 50 pouches per case. UDI: (01)10887709018065(17)250101(30)50(10)4572133. The Intravasc

…and 173 more.