OutlookRecalls & reported problems across all models

We found 25 models of Outlook by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 195 adverse event reports in the FDA's MAUDE database, received between Nov 17, 2016 and Mar 18, 2024 — classified as 2 deaths, 2 injuries, 191 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (58 reports).

24 FDA recall records name at least one of these models by its device identifier, 9 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Outlook recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Oct 29, 2025Open, Classified

   Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

   Z-0716-2026 · Root cause: Process control · Recall details · FDA record ↗

2. Oct 29, 2025Open, Classified

   Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

   Z-0709-2026 · Root cause: Process control · Recall details · FDA record ↗

3. Oct 29, 2025Open, Classified

   Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

   Z-0708-2026 · Root cause: Process control · Recall details · FDA record ↗

4. Oct 29, 2025Open, Classified

   Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

   Z-0707-2026 · Root cause: Process control · Recall details · FDA record ↗

5. Oct 29, 2025Open, Classified

   Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

   Z-0706-2026 · Root cause: Process control · Recall details · FDA record ↗

6. Jun 17, 2024Open, Classified

   Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

   Z-2404-2024 · Root cause: Process control · Recall details · FDA record ↗

7. Jun 17, 2024Open, Classified

   Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

   Z-2402-2024 · Root cause: Process control · Recall details · FDA record ↗

8. Jun 17, 2024Open, Classified

   Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

   Z-2377-2024 · Root cause: Process control · Recall details · FDA record ↗

9. Jun 17, 2024Open, Classified

   Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

   Z-2376-2024 · Root cause: Process control · Recall details · FDA record ↗

10. Aug 10, 2021Terminated

    Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

    Z-2560-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

11. Aug 10, 2021Terminated

    Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

    Z-2559-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

12. Aug 10, 2021Terminated

    Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

    Z-2558-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

13. Aug 10, 2021Terminated

    Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

    Z-2557-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

14. Aug 10, 2021Terminated

    Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

    Z-2556-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

15. Aug 10, 2021Terminated

    Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

    Z-2554-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

16. Aug 10, 2021Terminated

    Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

    Z-2552-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

17. Aug 10, 2021Terminated

    Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

    Z-2551-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

18. Aug 10, 2021Terminated

    Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

    Z-2550-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

19. Aug 10, 2021Terminated

    Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

    Z-2549-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

20. Aug 10, 2021Terminated

    Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

    Z-2548-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

21. Aug 10, 2021Terminated

    Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

    Z-2547-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

22. Aug 10, 2021Terminated

    Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

    Z-2546-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

23. Aug 10, 2021Terminated

    Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

    Z-2545-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

24. Aug 10, 2021Terminated

    Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

    Z-2544-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Outlook problems

Outlook models

25 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Outlook® 354213

  Set, administration, intravascular
  3 recalls47 reports
• Outlook® 354212

  Set, administration, intravascular
  3 recalls35 reports
• Outlook® 490564

  Pump, infusion
  3 recalls0 reports
• Outlook® 490361

  Stopcock, i.V. Set
  3 recalls0 reports
• Outlook® 354214

  Set, administration, intravascular
  2 recalls4 reports
• Outlook® 621-400ES

  Pump, infusion
  2 deaths61 reports
• Outlook® 354216

  Set, administration, intravascular
  1 recall10 reports
• Outlook® 470025

  Set, administration, intravascular
  1 recall7 reports
• Outlook® 470024

  Set, administration, intravascular
  1 recall3 reports
• Outlook® 477009

  Pump, infusion
  1 recall0 reports
• Outlook® 354215

  Set, administration, intravascular
  1 recall0 reports
• Outlook® 375118

  Set, administration, intravascular
  1 recall0 reports
• Outlook® NF3120

  Set, administration, intravascular
  1 recall0 reports
• Outlook® V7400

  Set, administration, intravascular
  1 recall0 reports
• Outlook® V7453

  Set, administration, intravascular
  1 recall0 reports
• Outlook® 474004

  Set, administration, intravascular
  1 recall0 reports
• Outlook® V7490

  Set, administration, intravascular
  6 reports
• Outlook® 621-400ESR

  Pump, infusion
  4 reports
• Outlook® US3120

  Set, administration, intravascular
  4 reports
• Outlook® US3130

  Set, administration, intravascular
  4 reports
• Outlook® V7450

  Set, administration, intravascular
  3 reports
• Outlook® 375196

  Set, administration, intravascular
  3 reports
• Outlook® 490580

  Stopcock, i.V. Set
  2 reports
• Outlook® 621-100ES

  Pump, infusion
  1 report
• Outlook® 621-200ES

  Pump, infusion
  1 report

Recent Outlook adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2024Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: OUTLOOK TUBING LEAKING. DETAILED INQUIRY DESCRIPTION: OUTLOOK TUBING LEAKING BY MAGNET. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18921913 ↗
• MalfunctionJan 29, 2024Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: CHEMO LEAKED ON TOP OF DRIP CHAMBER IN USING THE V7450 FOR TAXOL NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18595377 ↗
• MalfunctionFeb 27, 2023Device Alarm System; Excess Flow or Over-Infusion; Device Alarm System; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: BRAUN SYRINGE PUMP LOADED, SYRINGE PUMP FAILED TO RECOGNIZE SYRINGE AND DELIVERED ENTIRE VOLUME. SYRINGE WAS NOT CONNECTED TO PATIENT. NO INJURY REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16442132 ↗
• MalfunctionFeb 27, 2023Device Alarm System; Excess Flow or Over-Infusion; Device Alarm System; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: BRAUN SYRINGE PUMP LOADED, SYRINGE PUMP FAILED TO RECOGNIZE SYRINGE AND DELIVERED ENTIRE VOLUME. SYRINGE WAS NOT CONNECTED TO PATIENT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16442079 ↗
• MalfunctionJul 25, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: PRIMARY NURSE (RN) USED DOSE MODE TO PROGRAM FENTANYL WITH CO-SIGNING RN AS PRIMARY MEDICATION. RED SCREEN ON LEFT READ "FENTANYL" AS DRUG NAME. PATIENT TRANSPORTED TO CT SCAN VIA RN AND RENAL THERAPIST. RN RECEIVED PHONE CALL AROUND NOON FROM ICU PROVIDER THAT FAMILY HAD DECIDED TO TRANSITION TO COMFORT MEASURES ONLY AND CT SCAN CANCELED. APPROXIMATELY TWENTY MINUTES LATER ARRIVED BACK TO UNIT WITH PATIENT. 30 MINUTES LATER, DOSE INCREASED TO 37.5 MCG/HR. AN HOUR LATER RN ENTERED ROOM DUE TO IV PUMP ALARMING INFUSION COMPLETE (FENTANYL). FOUND FENTANYL RUNNING AT 37.5ML/HR, PER MEDICATION ADMINISTRATION RECORD (MAR) SHOULD HAVE BEEN RUNNING AT 37.5 MCG/HR FOR A RATE OF 1.9ML/HR. ICU PROVIDER INFORMED OF ABOVE. COSIGNING RN AWARE OF ABOVE. PUMP IMMEDIATELY SEQUESTERED. FENTANYL INFUSION PLACED ON NEW PUMP WITH NEW BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15092678 ↗
• MalfunctionJun 15, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY. EVENT 1: FLUID WAS DRIPPING FROM THE FIRST PORT CLOSEST TO THE SPIKE. NURSE REMOVED THE BAG FROM THE ROOM AND WHEN INSPECTED THE TUBING THE TUBING BROKE APART AT THE CONNECTION. THIS IS 2ND SET THAT HAD SAME PROBLEM IN EXACT SAME LOCATION. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14691637 ↗
• MalfunctionJun 15, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 1: 2 INSTANCES THIS PAST WEEK WHERE SIMILAR ISSUES OCCURRED WITH THE PRIMARY IV SETS. THE PROXIMAL IV PUSH PORTS ARE CRACKING AND CAUSING IV FLUIDS TO LEAK AT THE SITE FROM THAT PORT. I DO NOT HAVE THE ORIGINAL PACKAGING, AS THE ISSUE WAS IDENTIFIED AFTER THE TUBING WAS IN USE. FOR THESE 2 OCCURRENCES, THE BLOOD DID NOT BACK UP INTO THE TUBING. AND THE CRACK IS VISIBLE TO THE NAKED EYE WITH CLOSE VISUALIZATION. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14691562 ↗
• MalfunctionJun 15, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 2: 2 INSTANCES THIS PAST WEEK WHERE SIMILAR ISSUES OCCURRED WITH THE PRIMARY IV SETS. THE PROXIMAL IV PUSH PORTS ARE CRACKING AND CAUSING IV FLUIDS TO LEAK AT THE SITE FROM THAT PORT. I DO NOT HAVE THE ORIGINAL PACKAGING, AS THE ISSUE WAS IDENTIFIED AFTER THE TUBING WAS IN USE. FOR THESE 2 OCCURRENCES, THE BLOOD DID NOT BACK UP INTO THE TUBING. AND THE CRACK IS VISIBLE TO THE NAKED EYE WITH CLOSE VISUALIZATION. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14691561 ↗
• MalfunctionJun 15, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 2: FLUID WAS DRIPPING FROM THE FIRST PORT CLOSEST TO THE SPIKE. NURSE REMOVED THE BAG FROM THE ROOM AND WHEN INSPECTED THE TUBING THE TUBING BROKE APART AT THE CONNECTION. THIS IS 2ND SET THAT HAD SAME PROBLEM IN EXACT SAME LOCATION. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14691559 ↗
• MalfunctionJun 12, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THERE WAS A TINY HOLE NEAR THE CARTRIDGE AREA OF THE PUMP THAT CAUSED A LEAK. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14672297 ↗
• MalfunctionJun 9, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: IV PAIN MEDS TO SECONDARY PORT(CLOSEST TO PT). HEARD A CRACK AND NOTICED PORT WAS LEAKING. WHEN IV MED WAS UNSCREWED THE PORT DIDN'T LEAK. CHECKED BY SCREWING EMPTY SYRINGE TO IT AND IT STARTED LEAKING AGAIN. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14649111 ↗
• MalfunctionMay 18, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 2: DETAILED INQUIRY DESCRIPTION: OUTLOOK PUMP SET TUBING SEPARATED AT UPPER Y SITE WHILE NURSE WAS HANGING CHEMO TO ATTACH TO MED PORT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14427524 ↗
• MalfunctionMay 18, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 1: DETAILED INQUIRY DESCRIPTION: OUTLOOK PUMP SET TUBING SEPARATED AT UPPER Y SITE WHILE NURSE WAS HANGING CHEMO TO ATTACH TO MED PORT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14427414 ↗
• MalfunctionMay 17, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: CHEMO LEAK USING ONGUARD SYSTEM. DETAILED INQUIRY DESCRIPTION: IFOSFAMIDE WAS INITIATED ON A PATIENT THAT HAD A V1921 LINE. NURSE WAS PREVIOUSLY RUNNING MESNA AND SHE USED Y SITE OF EXTENSION 354213. SHE STOPPED MESNA AND CONNECTED IFOSFOMIDE USING ONGUARD LUER ADAPTER 412114. NURSES SUSPECT THE PROBLEM IS MESNA CAUSING PRECIPITATION AT PORT EITHER IN EXTENSION LINE OR ONGUARD ADAPTOR. IN THE PAST THEY NOTICED THAT AFTER DISCONNECTING LINES WITH MESNA IF THEY WANTED TO REINITIATE INFUSION WITH MESNA THEY WILL HAVE SOME PRECIPITATES THAT WILL NOT ALLOW INFUSION AND THEREFORE RESULTED IN LEAKS AT PORT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14414406 ↗
• MalfunctionApr 13, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 3: BRIEF INQUIRY DESCRIPTION OUTLOOK PUMP SETS LEAKING. NO INJURY REPORTED BUT CHEMOTHERAPY LEAKED ON THE PATIENTS SKIN AND CLOTHES.

  Patient problems: Chemical Exposure

  MAUDE report 14102039 ↗

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