PerfusorRecalls & reported problems across all models
B. Braun Medical Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
5 open recalls name at least one Perfusor model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 186
- Deaths reported
- 24
- Injuries reported
- 5
- Recalls
- 6
We found 5 models of Perfusor by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 186 adverse event reports in the FDA's MAUDE database, received between Dec 13, 2016 and Sep 30, 2026 — classified as 24 deaths, 5 injuries, 157 malfunctions.
The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (81 reports).
6 FDA recall records name at least one of these models by its device identifier, 5 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
Reports received per month, all models
Perfusor 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.
- Jun 14, 2024Open, Classified
Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with recognition, compatibility, and pump performance, such as overdose, underdose, delay in therapy, delay in occlusion alarms, and delay in feeding. Cardinal Health Monoject syringes are not compatible with the indicated pumps.
Z-2437-2024 · Root cause: Device Design · Recall details · FDA record ↗
- Jun 14, 2024Open, Classified
Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with recognition, compatibility, and pump performance, such as overdose, underdose, delay in therapy, delay in occlusion alarms, and delay in feeding. Cardinal Health Monoject syringes are not compatible with the indicated pumps.
Z-2436-2024 · Root cause: Device Design · Recall details · FDA record ↗
- Jun 14, 2024Open, Classified
Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with recognition, compatibility, and pump performance, such as overdose, underdose, delay in therapy, delay in occlusion alarms, and delay in feeding. Cardinal Health Monoject syringes are not compatible with the indicated pumps.
Z-2435-2024 · Root cause: Device Design · Recall details · FDA record ↗
- Jun 14, 2024Open, Classified
Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with recognition, compatibility, and pump performance, such as overdose, underdose, delay in therapy, delay in occlusion alarms, and delay in feeding. Cardinal Health Monoject syringes are not compatible with the indicated pumps.
Z-2434-2024 · Root cause: Device Design · Recall details · FDA record ↗
- Jun 14, 2024Open, Classified
Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with recognition, compatibility, and pump performance, such as overdose, underdose, delay in therapy, delay in occlusion alarms, and delay in feeding. Cardinal Health Monoject syringes are not compatible with the indicated pumps.
Z-2433-2024 · Root cause: Device Design · Recall details · FDA record ↗
- Feb 7, 2022Terminated
Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion accuracy that can result in delays in therapy, overinfusion, or underinfusion.
Z-0819-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Perfusor problems
Device problems
- Insufficient Flow or Under Infusion81
- Excess Flow or Over-Infusion71
- Adverse Event Without Identified Device or Use Problem23
- Infusion or Flow Problem13
- Device Alarm System8
- Pumping Stopped3
- Device Difficult to Setup or Prepare2
- Device Sensing Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions109
- No Known Impact Or Consequence To Patient23
- Cardiac Arrest22
- Abdominal Distention21
- Blood Bicarbonate Decreased21
- Renal Impairment21
- Urethral Stenosis/Stricture21
- No Consequences Or Impact To Patient9
Perfusor models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Perfusor® 8713030UPump, infusion, enteral2 recalls3 deaths76 reports
- Perfusor® 8713031UPUMP, INFUSION, ENTERAL1 recall21 deaths87 reports
- Perfusor® 8713080UPump, infusion1 recall12 reports
- Perfusor® 8713032UPUMP, INFUSION, ENTERAL1 recall7 reports
- Perfusor® 8713040UPump, infusion, pca1 recall4 reports
Recent Perfusor adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Insufficient Flow or Under Infusion
As reported by the user facility:Intended infusion was 10 mL, actual was ~ 6.5 mL; pump documented a total of 10 mL was infused.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947797 ↗MalfunctionSep 16, 2026Insufficient Flow or Under Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791876 ↗MalfunctionAug 12, 2026Excess Flow or Over-Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50227733 ↗MalfunctionAug 12, 2026Excess Flow or Over-Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50220959 ↗MalfunctionAug 3, 2026Device Alarm System; Insufficient Flow or Under Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50122216 ↗MalfunctionJul 14, 2026Insufficient Flow or Under Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25817266 ↗MalfunctionJul 14, 2026Insufficient Flow or Under Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25817183 ↗MalfunctionJul 14, 2026Excess Flow or Over-Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25811259 ↗MalfunctionJul 7, 2026Insufficient Flow or Under Infusion
AS REPORTED BY THE USER FACILITY: DURING A B. BRAUN/ORACLE INTEGRATION GO-LIVE EVENT, A NURSE REPORTEDLY AUTO-PROGRAMMED AN INTERMITTENT PERFUSOR INFUSION WITH A VOLUME OF 0.43 ML, AND WHEN THE PUMP INDICATED THAT THE INFUSION WAS COMPLETE VIA SYRINGE END, THE FULL VOLUME OF 0.43 ML REMAINED IN THE SYRINGE PER VISUAL INSPECTION. IN THE ORACLE EHR, AN INFUSED VOLUME OF 0.42 ML WAS DISPLAYED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25733348 ↗MalfunctionJun 23, 2026Excess Flow or Over-Infusion
AS REPORTED BY THE USER FACILITY: FENTANYL CONTINUOUS INFUSION SET UP AND CHECKED. PER BEDSIDE NURSE SHE HAD TO PAUSE THE INFUSION PUMP TO CHECK PRESSURES-PUMP PLACED IN STANDBY. NOTHING WAS MODIFIED UPON RESTARTING AND WITH 20 MINUTES THE SYRINGE HAD INFUSED. THE ORIGINAL INFUSION WAS AT .05CC AND WAS LATER FOUND INFUSING AT 25ML/HR.. IT WAS ORIGINALLY STARTED AS A CONTINUOUS SEDATION. GTB AND PLASTICS NOTIFIED. TREATMENT ORDERS GIVEN. PCA STOPPED. PUMP AND TUBING REMOVED.. PUMP TURNED IN TO MAINTENANCE. AFTER SPEAKING TO GTB THIS SIMILAR ISSUE WAS NOTED WIN @D WITH A PCA SYRINGE BEING INFUSED AS A BOLUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25596938 ↗MalfunctionJun 2, 2026Excess Flow or Over-Infusion
AS REPORTED BY THE USER FACILITY: OVERINFUSION OF MED. RN IN PICU PROGRAMMED BD 30ML SYRINGE (SELECTED CORRECT DISPOSABLE) 25% ALBUMIN TO INFUSE AT A RATE OF 6.5ML/HR, VTBI 13ML. MED INFUSED IN 1 HR 20 MIN, RATHER THAN EXPECTED 2 HRS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25361090 ↗MalfunctionMay 22, 2026Insufficient Flow or Under Infusion
ACCORDING TO THE COMPLAINANT, DURING AN INFUSION IN (B)(6) 2026, THE INFUSION PUMP UNDER UNFUSED AND DID NOT COMPLETE DELIVERY OF THE PROGRAMMED MEDICATION VOLUME. REPORTEDLY, APPROXIMATELY 6 MILLILITERS (ML) OF MEDICATION REMAINED IN THE SYRINGE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25260545 ↗MalfunctionMay 20, 2026Insufficient Flow or Under Infusion
AS REPORTED BY THE USER FACILITY: SN (B)(6). PUMP WAS UNDER INFUSING, "PUMP DOES NOT COMPLETE THE DOSAGE OF THE MEDICATION". NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25232070 ↗InjuryMay 12, 2026Excess Flow or Over-Infusion
AS REPORTED BY THE USER FACILITY: ANESTHESIOLOGIST BEGAN ANESTHESIA INDUCTION AND SHORTLY AFTER NOTED THAT THE PATIENT STARTED SEIZING. PATIENT WAS EMERGENTLY INTUBATED TO PROTECT THE AIRWAY, WAS STABILIZED AND SURGERY WAS ABLE TO BE COMPLETED. POST-OPERATIVELY PATIENT REMAINED INTUBATED AND REMAINED IN ICU OVERNIGHT. THE PATIENT WAS EXTUBATED IN THE MORNING AND REPORTS ARE THAT THERE ARE NO SIGNS OF IMPAIRMENT. BASED ON A REVIEW OF THE KEYBOARD HISTORY AND DEVICE HISTORY REPORTS BIOMED OBTAINED FROM THE PUMP, THE PUMP WAS PROGRAMMED STARTING AT 2:17 PM AND AT 2:18 PM THE SYRINGE HOLDER WAS OPENED. THERE IS NO DATA UNTIL 2:54 PM AT WHICH TIME THERE WAS AN ERROR FOLLOWED BY SYRINGE BRAND AND SIZE WAS SELECTED WITH A SYRINGE FAULT ERROR.
Patient problems: Convulsion/Seizure
MAUDE report 25148298 ↗MalfunctionMay 4, 2026Excess Flow or Over-Infusion
AS REPORTED BY THE USER FACILITY: POTENTIAL ISSUE WITH THE IV INFUSION PUMP/PROGRAMMING LEADING TO LIKELY MEDICATION ERROR RECOGNIZED AS FENTANYL SYRINGE SCANNED AND STARTED AT 1854, IMMEDIATELY PRIOR TO CHANGE OF SHIFT ALARMED WITH VTBI WARNING AND APPEARS EMPTY AT APPROX. 1945. GTB APP, CHARGE NURSE, AND PHARMACY NOTIFIED WITHOUT FURTHER INTERVENTIONS NEEDED AS PATIENT IS ALREADY INTUBATED AND MECHANICALLY VENTILATED. NO SIGNS OF COMPLICATIONS NOTED ASIDE FROM DECREASED RAAS. PROPOFOL DOSE CUT SIGNIFICANTLY TO ASSESS NEURO STATUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25072227 ↗
Other B. Braun Medical Inc. products
- Infusomat54 models · 2,783 reports · 30 recalls
- IV Administration Set153 models · 281 reports · 68 recalls
- Hemodialysis Bloodlines9 models · 2,179 reports · 14 recalls
- Outlook25 models · 195 reports · 24 recalls
- Perifix57 models · 224 reports · 20 recalls
- Extension Set41 models · 101 reports · 16 recalls
- Design Options116 models · 132 reports · 14 recalls
- Blood Administration Set24 models · 177 reports · 13 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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