ICU Medical AM6130Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00887709087712), received between Jul 21, 2023 and Mar 10, 2025 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (18 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, ON AN UNKNOWN DATE, A 6" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING LUER GENERATED A LEAK DURING PATIENT USE. IT WAS STATED IN THE REPORT THAT THE PRODUCT WAS LEAKING. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21569271 ↗
• MalfunctionOct 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AN EVENT ON AN UNKNOWN DATE INVOLVING A 6" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING LUER RESULTED IN LEAKAGE. IT WAS REPORTED THAT THEIR CICU HAD LEAKING ISSUES WITH THE AM6130 MANIFOLD SET. THEY HAD ISSUES WHERE THERE WAS LEAKING FROM ONE OF THE MANIFOLD CLAVES. SAMPLE IS AVAILABLE FOR EVALUATION. THERE WAS UNKNOWN PATIENT INVOLVEMENT, UNKNOWN ADVERSE EVENT AND UNKNOWN DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20568808 ↗
• MalfunctionOct 29, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AN EVENT ON AN UNKNOWN DATE INVOLVING A 6" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING LUER EXPERIENCED LEAKAGE. IT WAS REPORTED THAT THEIR CICU HAD LEAKING ISSUES WITH THE AM6130 MANIFOLD SET. THEY HAD ISSUES WHERE THE TUBING MEETS THE MANIFOLD. SAMPLE IS AVAILABLE FOR EVALUATION. THERE WAS UNKNOWN PATIENT INVOLVEMENT, UNKNOWN ADVERSE EVENT AND UNKNOWN DELAY IN THERAPY. AN ADDITIONAL USED DEVICE WAS RECEIVED FOR TESTING. PLEASE SEE H11 FOR RESULTS OF THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20561098 ↗
• MalfunctionSep 16, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AN EVENT ON AN UNKNOWN DATE INVOLVING A 6" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING LUER EXPERIENCED LEAKAGE. IT WAS REPORTED THAT THEIR CICU HAD LEAKING ISSUES WITH THE AM6130 MANIFOLD SET. THEY HAD ISSUES WHERE THE TUBING MEETS THE MANIFOLD. SAMPLE IS AVAILABLE FOR EVALUATION. THERE WAS UNKNOWN PATIENT INVOLVEMENT, UNKNOWN ADVERSE EVENT AND UNKNOWN DELAY IN THERAPY.

  Patient problems: Insufficient Information

  MAUDE report 20228631 ↗
• MalfunctionSep 16, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AN EVENT ON AN UNKNOWN DATE INVOLVING A 6" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING LUER RESULTED IN LEAKAGE. IT WAS REPORTED THAT THEIR CICU HAD LEAKING ISSUES WITH THE AM6130 MANIFOLD SET. THEY HAD ISSUES WHERE THERE WAS LEAKING FROM ONE OF THE MANIFOLD CLAVES. SAMPLE IS AVAILABLE FOR EVALUATION. THERE WAS UNKNOWN PATIENT INVOLVEMENT, UNKNOWN ADVERSE EVENT AND UNKNOWN DELAY IN THERAPY.

  Patient problems: Insufficient Information

  MAUDE report 20226812 ↗
• MalfunctionJul 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 6" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING LUER WHERE IT WAS REPORTED THAT THE DEVICE LEAKED. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN HARM OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19829765 ↗
• MalfunctionJul 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AN EVENT INVOLVING 6" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING LUER EXPERIENCED LEAKAGE. IT WAS REPORTED THAT THE MANIFOLD LEAKING ON PROXIMAL SIDE BETWEEN THE EXTENSION TUBING AND MANIFOLD HUBS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN HARM OR ADVERSE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 19819959 ↗
• MalfunctionJul 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 6" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING LUER. THE CUSTOMER REPORTED THAT THERE WAS LEAKING AT BONDED PART OF MANIFOLD. THERE WAS UNKNOWN PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT. THIS IS REPORT 3 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19813111 ↗
• MalfunctionJul 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 6" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING LUER. THE CUSTOMER REPORTED THAT THERE WAS LEAKING AT BONDED PART OF MANIFOLD. THERE WAS UNKNOWN PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT. THIS IS REPORT 1 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19813106 ↗
• MalfunctionJul 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 6" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING LUER. THE CUSTOMER REPORTED THAT THERE WAS LEAKING AT BONDED PART OF MANIFOLD. THERE WAS UNKNOWN PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT. THIS IS REPORT 2 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19813065 ↗
• MalfunctionAug 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 6" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING LUER THAT WAS REPORTED TO BE LEAKING FROM THE 6-GANG MANIFOLD. THERE WAS NO REPORT OF HUMAN HARM ASSOCIATED WITH THIS COMPLAINT. THIS EMDR RECORD REFLECTS THE SECOND OF TWO OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17586474 ↗
• MalfunctionAug 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 6" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING LUER THAT WAS REPORTED TO BE LEAKING FROM THE 6-GANG MANIFOLD. THERE WAS NO REPORT OF HUMAN HARM ASSOCIATED WITH THIS COMPLAINT. THIS EMDR RECORD REFLECTS THE FIRST OF TWO OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17586460 ↗
• MalfunctionJul 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE INCIDENT INVOLVED A 6" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING LUER ON AN UNKNOWN DATE BETWEEN (B)(6)2023 AND (B)(6) 2023. THERE WAS A REPORT OF LEAKING FROM THE 6-GANG MANIFOLD. THE PROBLEM WAS DISCOVERED INITIALLY ATTACHED TO A PATIENT BUT SUBSEQUENTLY HE BELIEVES THE NURSES HAVE BEEN FLUSHING THEM TO DETERMINE IF THEY WERE LEAKING OR NOT BEFORE ATTACHING HEM TO PATIENT. THE ISSUE PRESENTS PRETTY CONSISTENTLY AS BEING AT THE DISTAL PORT. THE MEDICATION/DRUG INVOLVED WAS PRESUMABLY NORMAL SALINE. THE SET UP WAS IN SOME INSTANCES ATTACHED TO A FILTER BUT NOT ALWAYS. FURTHERMORE, IT WAS REPORTED THAT THE TUBING WAS REPLACED AND THERAPY WAS RESUMED. THERE WERE NOT ANY HOLES, CUTS, TEARS OR ANY OBVIOUS DEFECTS NOTED ON THE PRODUCT. THERE WAS PATIENT INVOLVEMENT REPORTED BUT NO PATIENT HARM. THIS IS THE SIXTH OF SIX REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17370453 ↗
• MalfunctionJul 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE INCIDENT INVOLVED A 6" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING LUER ON AN UNKNOWN DATE BETWEEN (B)(6) 2023 AND (B)(6) 2023. THERE WAS A REPORT OF LEAKING FROM THE 6-GANG MANIFOLD. THE PROBLEM WAS DISCOVERED INITIALLY ATTACHED TO A PATIENT BUT SUBSEQUENTLY HE BELIEVES THE NURSES HAVE BEEN FLUSHING THEM TO DETERMINE IF THEY WERE LEAKING OR NOT BEFORE ATTACHING HEM TO PATIENT. THE ISSUE PRESENTS PRETTY CONSISTENTLY AS BEING AT THE THE DISTAL PORT. THE MEDICATION/DRUG INVOLVED WAS PRESUMABLY NORMAL SALINE. THE SET UP WAS IN SOME INSTANCES ATTACHED TO A FILTER BUT NOT ALWAYS. FURTHERMORE, IT WAS REPORTED THAT THE TUBING WAS REPLACED AND THERAPY WAS RESUMED. THERE WERE NOT ANY HOLES, CUTS, TEARS OR ANY OBVIOUS DEFECTS NOTED ON THE PRODUCT. THERE WAS PATIENT INVOLVEMENT REPORTED BUT NO PATIENT HARM. THIS IS THE FOURTH OF SIX REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17370449 ↗
• MalfunctionJul 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE INCIDENT INVOLVED A 6" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING LUER ON AN UNKNOWN DATE BETWEEN 29-JUNE-2023 AND 8-JULY-2023. THERE WAS A REPORT OF LEAKING FROM THE 6-GANG MANIFOLD. THE PROBLEM WAS DISCOVERED INITIALLY ATTACHED TO A PATIENT BUT SUBSEQUENTLY HE BELIEVES THE NURSES HAVE BEEN FLUSHING THEM TO DETERMINE IF THEY WERE LEAKING OR NOT BEFORE ATTACHING HEM TO PATIENT. THE ISSUE PRESENTS PRETTY CONSISTENTLY AS BEING AT THE DISTAL PORT. THE MEDICATION/DRUG INVOLVED WAS PRESUMABLY NORMAL SALINE. THE SET UP WAS IN SOME INSTANCES ATTACHED TO A FILTER BUT NOT ALWAYS. FURTHERMORE, IT WAS REPORTED THAT THE TUBING WAS REPLACED AND THERAPY WAS RESUMED. THERE WERE NOT ANY HOLES, CUTS, TEARS OR ANY OBVIOUS DEFECTS NOTED ON THE PRODUCT. THERE WAS PATIENT INVOLVEMENT REPORTED BUT NO PATIENT HARM. THIS IS THE SECOND OF SIX REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17370448 ↗
• MalfunctionJul 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE INCIDENT INVOLVED A 6" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING LUER ON AN UNKNOWN DATE BETWEEN (B)(6) 2023 AND (B)(6) 2023. THERE WAS A REPORT OF LEAKING FROM THE 6-GANG MANIFOLD. THE PROBLEM WAS DISCOVERED INITIALLY ATTACHED TO A PATIENT BUT SUBSEQUENTLY HE BELIEVES THE NURSES HAVE BEEN FLUSHING THEM TO DETERMINE IF THEY WERE LEAKING OR NOT BEFORE ATTACHING HEM TO PATIENT. THE ISSUE PRESENTS PRETTY CONSISTENTLY AS BEING AT THE DISTAL PORT. THE MEDICATION/DRUG INVOLVED WAS PRESUMABLY NORMAL SALINE. THE SET UP WAS IN SOME INSTANCES ATTACHED TO A FILTER BUT NOT ALWAYS. FURTHERMORE, IT WAS REPORTED THAT THE TUBING WAS REPLACED AND THERAPY WAS RESUMED. THERE WERE NOT ANY HOLES, CUTS, TEARS OR ANY OBVIOUS DEFECTS NOTED ON THE PRODUCT. THERE WAS PATIENT INVOLVEMENT REPORTED BUT NO PATIENT HARM. THIS IS THE FIFTH OF SIX REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17370447 ↗
• MalfunctionJul 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE INCIDENT INVOLVED A 6" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING LUER ON AN UNKNOWN DATE BETWEEN (B)(6) 2023 AND (B)(6) 2023. THERE WAS A REPORT OF LEAKING FROM THE 6-GANG MANIFOLD. THE PROBLEM WAS DISCOVERED INITIALLY ATTACHED TO A PATIENT BUT SUBSEQUENTLY HE BELIEVES THE NURSES HAVE BEEN FLUSHING THEM TO DETERMINE IF THEY WERE LEAKING OR NOT BEFORE ATTACHING HEM TO PATIENT. THE ISSUE PRESENTS PRETTY CONSISTENTLY AS BEING AT THE THE DISTAL PORT. THE MEDICATION/DRUG INVOLVED WAS PRESUMABLY NORMAL SALINE. THE SET UP WAS IN SOME INSTANCES ATTACHED TO A FILTER BUT NOT ALWAYS. FURTHERMORE, IT WAS REPORTED THAT THE TUBING WAS REPLACED AND THERAPY WAS RESUMED. THERE WERE NOT ANY HOLES, CUTS, TEARS OR ANY OBVIOUS DEFECTS NOTED ON THE PRODUCT. THERE WAS PATIENT INVOLVEMENT REPORTED BUT NO PATIENT HARM. THIS IS THE FIRST OF SIX REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17370444 ↗
• MalfunctionJul 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE INCIDENT INVOLVED A 6" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING LUER ON AN UNKNOWN DATE BETWEEN (B)(6) 2023 AND (B)(6) 2023. THERE WAS A REPORT OF LEAKING FROM THE 6-GANG MANIFOLD. THE PROBLEM WAS DISCOVERED INITIALLY ATTACHED TO A PATIENT BUT SUBSEQUENTLY HE BELIEVES THE NURSES HAVE BEEN FLUSHING THEM TO DETERMINE IF THEY WERE LEAKING OR NOT BEFORE ATTACHING HEM TO PATIENT. THE ISSUE PRESENTS PRETTY CONSISTENTLY AS BEING AT THE DISTAL PORT. THE MEDICATION/DRUG INVOLVED WAS PRESUMABLY NORMAL SALINE. THE SET UP WAS IN SOME INSTANCES ATTACHED TO A FILTER BUT NOT ALWAYS. FURTHERMORE, IT WAS REPORTED THAT THE TUBING WAS REPLACED AND THERAPY WAS RESUMED. THERE WERE NOT ANY HOLES, CUTS, TEARS OR ANY OBVIOUS DEFECTS NOTED ON THE PRODUCT. THERE WAS PATIENT INVOLVEMENT REPORTED BUT NO PATIENT HARM. THIS IS THE THIRD OF SIX REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17370443 ↗

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-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-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-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-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-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-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
• Z-0260-2021 · Jul 6, 2020 · Terminated
  124" (315 cm) 60 Drop 150 mL Burette Set (w/Clave, Shut-Off), Remv 2 Gang Clave Stopcocks, 2 Clave, Rotating Luer, 2 Ext. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709034
• Z-0226-2021 · Jul 6, 2020 · Terminated
  112 IN(284cm) APPX 14.6ml, 15 Drop Set 3 MicroClave, 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case. UDI:(01)10887709088518(17)241101(30)25(10)4475764 (01)108
• 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-0210-2021 · Jul 6, 2020 · Terminated
  13 IN (33cm) APPX 0.96 ml, PENTAFUSE SMALLBORE SET, NanoClave, 3 MicroClave Clear. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709090245(17)250101(30)50(10)4557533; (01)108

…and 173 more.