VistaRecalls & reported problems across all models
B. Braun Medical Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Vista model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 86
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 2 models of Vista by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 86 adverse event reports in the FDA's MAUDE database, received between Dec 2, 2016 and Nov 26, 2025 — classified as 86 malfunctions.
The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (38 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 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
Vista 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.
- 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-0715-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported Vista problems
Device problems
- Excess Flow or Over-Infusion38
- Insufficient Flow or Under Infusion31
- Fail-Safe Did Not Operate6
- Infusion or Flow Problem6
- Failure to Charge4
- Device Alarm System3
- Failure to Pump3
- False Alarm3
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- No Known Impact Or Consequence To Patient22
- No Consequences Or Impact To Patient21
- No Patient Involvement7
- No Information2
- Electric Shock1
- Headache1
- Hot Flashes/Flushes1
Vista models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Vista® 637-202Pump, infusion85 reports
- Vista® US9923FSet, administration, intravascular1 recall1 report
Recent Vista adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionNov 26, 2025False Alarm; Failure to Charge; Failure to Pump; False Alarm; Failure to Charge; Failure to Pump
AS REPORTED BY THE USER FACILITY: THESE ARE THE ISSUES WITH THE 3 PUMPS BEING REPORTED: SERIAL NR#'S (B)(6). PUMPS DO NOT HOLD A CHARGE DESPITE BEING PLUGGED IN OVERNIGHT CONTINUOUSLY SAY 'OCCLUSION' OR 'AIR IN LINE' DESPITE NEITHER OF WHICH REALLY PRESENT. WHEN PRESSING START FOR INFUSION, FREQUENTLY WILL FLASH FROM SEVERAL DIFFERENT SCREENS RANDOMLY AND SUDDENLY NOT WORK. NEED TO TURN OFF AND BACK ON AND RESET. SOMETIMES WILL JUST NOT INFUSE DESPITE EVERYTHING BEING CORRECT. NEED TO TURN OFF AND ON SEVERAL TIMES BEFORE IT EITHER STARTS WORKING OR NEED TO JUST NOT USE PUMP AND RUN BY GRAVITY. PUMP SN: (B)(6) - MDR#: 9610825-2025-00680, PUMP SN: (B)(6) - MDR#: 9610825-2025-00681.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23658857 ↗MalfunctionNov 20, 2025False Alarm; Failure to Charge; Failure to Pump; False Alarm; Failure to Charge; Failure to Pump
AS REPORTED BY THE USER FACILITY: THESE ARE THE ISSUES WITH THE 3 PUMP BEING REPORTED: SERIAL NR#'S (B)(6). · PUMPS DO NOT HOLD A CHARGE DESPITE BEING PLUGGED IN OVERNIGHT · CONTINUOUSLY SAY 'OCCLUSION' OR 'AIR IN LINE' DESPITE NEITHER OF WHICH REALLY PRESENT. · WHEN PRESSING START FOR INFUSION, FREQUENTLY WILL FLASH FROM SEVERAL DIFFERENT SCREENS RANDOMLY AND SUDDENLY NOT WORK. NEED TO TURN OFF AND BACK ON AND RESET. · SOMETIMES WILL JUST NOT INFUSE DESPITE EVERYTHING BEING CORRECT. NEED TO TURN OFF AND ON SEVERAL TIMES BEFORE IT EITHER STARTS WORKING OR NEED TO JUST NOT USE PUMP AND RUN BY GRAVITY. PUMP SN: (B)(6) - MDR#: 9610825-2025-00681. PUMP SN: (B)(6) - MDR#: 9610825-2025-00682.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23610207 ↗MalfunctionNov 19, 2025False Alarm; Failure to Charge; Failure to Pump; False Alarm; Failure to Charge; Failure to Pump
AS REPORTED BY THE USER FACILITY: THESE ARE THE ISSUES WITH THE 3 PUMP BEING REPORTED: SERIAL NR#'S (B)(6). PUMPS DO NOT HOLD A CHARGE DESPITE BEING PLUGGED IN OVERNIGHT CONTINUOUSLY SAY 'OCCLUSION' OR 'AIR IN LINE' DESPITE NEITHER OF WHICH REALLY PRESENT WHEN PRESSING START FOR INFUSION, FREQUENTLY WILL FLASH FROM SEVERAL DIFFERENT SCREENS RANDOMLY AND SUDDENLY NOT WORK. NEED TO TURN OFF AND BACK ON AND RESET SOMETIMES WILL JUST NOT INFUSE DESPITE EVERYTHING BEING CORRECT. NEED TO TURN OFF AND ON SEVERAL TIMES BEFORE IT EITHER STARTS WORKING OR NEED TO JUST NOT USE PUMP AND RUN BY GRAVITY. PUMP SN: (B)(6) - MDR#: 9610825-2025-00680. PUMP SN: (B)(6) - MDR#: 9610825-2025-00682.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23593882 ↗MalfunctionNov 12, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
AS REPORTED BY THE USER FACILITY: REPORTER STATED THAT THE PUMP APPEARED TO HAVE OVER-INFUSED. THE BIOLOGIC ADMINISTERED WAS TYSABRI FOR MULTIPLE SCLEROSIS. THE INFUSION WAS INTENDED TO DELIVER A 100 ML BAG OVER ONE HOUR. WHEN THE INFUSION TIMER STOPPED, THERE WERE 20 MINUTES REMAINING, AND THE PUMP INDICATED 40 ML LEFT; HOWEVER, THE BAG WAS COMPLETELY EMPTY. THE PATIENT REMAINED STABLE AND WAS MONITORED FOR ONE HOUR POST-INFUSION DUE TO THE POTENTIAL FOR SEVERE SIDE EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23533151 ↗MalfunctionNov 3, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
AS REPORTED BY THE USER FACILITY: UNDER INFUSION - (NO PATIENT INJURY / NO ADDITIONAL DETAILS PROVIDED).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23453019 ↗MalfunctionFeb 10, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
AS REPORTED BY THE USER FACILITY: ACCORDING TO THE COMPLAINANT, THE INFUSION VOLUME PROGRAMMED IN VISTA BASIC DOES NOT CORRESPOND WITH THE ACTUAL VOLUME DELIVERED; FOR INSTANCE, IF IT IS SET TO DELIVER 500 MILLILITERS (ML), IT MAY ONLY INFUSE 400ML. THIS HAPPENED TO SEVERAL OF OUR PATIENTS (THEIR IVIG IS ORDERED TO RUN OVER A RANGE OF TIME, USUALLY 2-4 HOURS, AND THIS RESULTED IN A SLIGHT DELAY. THIS WAS ADJUSTED BY ADDING TIME TO THE PUMPS AND THE INFUSION WAS ABLE TO RUN WITHOUT FURTHER ISSUE, BUT NOT AT THE TIME THAT WAS INITIALLY PROGRAMMED/INTENDED). REFERENCE MDR ID 9610825-2025-00051 AND 9610825-2025-00065 FOR OTHER ASSOCIATED EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21351203 ↗MalfunctionFeb 10, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
AS REPORTED BY THE USER FACILITY: ACCORDING TO THE COMPLAINANT, THE INFUSION VOLUME PROGRAMMED IN VISTA BASIC DOES NOT CORRESPOND WITH THE ACTUAL VOLUME DELIVERED; FOR INSTANCE, IF IT IS SET TO DELIVER 500 MILLILITERS (ML), IT MAY ONLY INFUSE 400ML. THIS HAPPENED TO SEVERAL OF OUR PATIENTS (THEIR IVIG IS ORDERED TO RUN OVER A RANGE OF TIME, USUALLY 2-4 HOURS, AND THIS RESULTED IN A SLIGHT DELAY. THIS WAS ADJUSTED BY ADDING TIME TO THE PUMPS AND THE INFUSION WAS ABLE TO RUN WITHOUT FURTHER ISSUE, BUT NOT AT THE TIME THAT WAS INITIALLY PROGRAMMED/INTENDED). REFERENCE MDR ID 9610825-2025-00051 AND 9610825-2025-00064 FOR OTHER ASSOCIATED EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21351202 ↗MalfunctionFeb 10, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
AS REPORTED BY THE USER FACILITY: ACCORDING TO THE COMPLAINANT, THE INFUSION VOLUME PROGRAMMED IN VISTA BASIC DOES NOT CORRESPOND WITH THE ACTUAL VOLUME DELIVERED; FOR INSTANCE, IF IT IS SET TO DELIVER 500 MILLILITERS (ML), IT MAY ONLY INFUSE 400ML. THIS HAPPENED TO SEVERAL OF OUR PATIENTS (THEIR IVIG IS ORDERED TO RUN OVER A RANGE OF TIME, USUALLY 2-4 HOURS, AND THIS RESULTED IN A SLIGHT DELAY. THIS WAS ADJUSTED BY ADDING TIME TO THE PUMPS AND THE INFUSION WAS ABLE TO RUN WITHOUT FURTHER ISSUE, BUT NOT AT THE TIME THAT WAS INITIALLY PROGRAMMED/INTENDED). REFERENCE MDR ID 9610825-2025-00064 AND 9610825-2025-00065 FOR OTHER ASSOCIATED EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21349363 ↗MalfunctionJan 30, 2025Infusion or Flow Problem; Infusion or Flow Problem
AS REPORTED BY THE USER FACILITY: NOT RUNNING CORRECTLY, RUNNING AT A FASTER RATE THAN PROGRAMMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21275651 ↗MalfunctionNov 14, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
AS REPORTED BY THE SALES REPRESENTATIVE: HE REPORTED THAT THE CUSTOMER HAS REPORTED FIVE INCIDENTS WERE THE DEVICES HAVE MALFUNCTION AS DESCRIBED. AS A RESULT, THE SALES REPRESENTATIVE WENT ON SITE TO HELP TROUBLE SHOOT (A NEW NURSE WHO HAD NOT USED THE PUMPS IN THE PAST WAS THE INITIAL REPORTER). THE SALES REPRESENTATIVE TESTED THE PUMPS USING SALINE AND COULD NOT REPLICATE THE REPORTED EVENT. THERE WERE LITTLE BUBBLES OBSERVED AS WELL AS BIG BUBBLES OBSERVED AND THE PUMP FUNCTION AS INTENDED. THE SALES REPRESENTATIVE POINTED OUT THAT THE CUSTOMER DID MENTION THAT THEY ARE PROGRAMMING THE INFUSIONS TO ACCOUNT FOR THE BAG VOLUME AND HAVE BEEN INCLUDING THE 10% OVERFILL. THE SALES REPRESENTATIVE ADVISED THAT THEY SHOULD INFUSE ONLY FOR THE CORRECT VOLUME AND THEN RE-RUN THE INFUSION IF THERE ARE RESIDUAL AMOUNTS IN THE BAG. THE CUSTOMER STRESSED THAT SALINE WORKS FINE, BUT IT IS WHEN THEY USE CISPLATIN AND LEUCOVORIN THAT THEY ENCOUNTER THE ISSUE. THE THREE SERIAL NUMBERS WERE REPORTED AS (B)(6). TWO OF THE PUMPS MALFUNCTIONED ONE TIME, AND ONE OF THE PUMPS MALFUNCTIONED THREE TIMES. THE REPORTED EVENT OCCURRED THREE TIMES WITH THE USE OF SERIAL NUMBER (B)(6). THIS REPORT IS FOR EVE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20684440 ↗MalfunctionNov 14, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
AS REPORTED BY THE SALES REPRESENTATIVE: HE REPORTED THAT THE CUSTOMER HAS REPORTED FIVE INCIDENTS WERE THE DEVICES HAVE MALFUNCTION AS DESCRIBED. AS A RESULT, THE SALES REPRESENTATIVE WENT ON SITE TO HELP TROUBLE SHOOT (A NEW NURSE WHO HAD NOT USED THE PUMPS IN THE PAST WAS THE INITIAL REPORTER). THE SALES REPRESENTATIVE TESTED THE PUMPS USING SALINE AND COULD NOT REPLICATE THE REPORTED EVENT. THERE WERE LITTLE BUBBLES OBSERVED AS WELL AS BIG BUBBLES OBSERVED AND THE PUMP FUNCTION AS INTENDED. THE SALES REPRESENTATIVE POINTED OUT THAT THE CUSTOMER DID MENTION THAT THEY ARE PROGRAMMING THE INFUSIONS TO ACCOUNT FOR THE BAG VOLUME AND HAVE BEEN INCLUDING THE 10% OVERFILL. THE SALES REPRESENTATIVE ADVISED THAT THEY SHOULD INFUSE ONLY FOR THE CORRECT VOLUME AND THEN RE-RUN THE INFUSION IF THERE ARE RESIDUAL AMOUNTS IN THE BAG. THE CUSTOMER STRESSED THAT SALINE WORKS FINE, BUT IT IS WHEN THEY USE CISPLATIN AND LEUCOVORIN THAT THEY ENCOUNTER THE ISSUE. THE THREE SERIAL NUMBERS WERE REPORTED AS (B)(6). TWO OF THE PUMPS MALFUNCTIONED ONE TIME, AND ONE OF THE PUMPS MALFUNCTIONED THREE TIMES. THE REPORTED EVENT OCCURRED THREE TIMES WITH THE USE OF SERIAL NUMBER (B)(6). THIS REPORT IS FOR EVE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20684431 ↗MalfunctionNov 14, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
AS REPORTED BY THE SALES REPRESENTATIVE: HE REPORTED THAT THE CUSTOMER HAS REPORTED FIVE INCIDENTS WERE THE DEVICES HAVE MALFUNCTION AS DESCRIBED. AS A RESULT, THE SALES REPRESENTATIVE WENT ON SITE TO HELP TROUBLE SHOOT (A NEW NURSE WHO HAD NOT USED THE PUMPS IN THE PAST WAS THE INITIAL REPORTER). THE SALES REPRESENTATIVE TESTED THE PUMPS USING SALINE AND COULD NOT REPLICATE THE REPORTED EVENT. THERE WERE LITTLE BUBBLES OBSERVED AS WELL AS BIG BUBBLES OBSERVED AND THE PUMP FUNCTION AS INTENDED. THE SALES REPRESENTATIVE POINTED OUT THAT THE CUSTOMER DID MENTION THAT THEY ARE PROGRAMMING THE INFUSIONS TO ACCOUNT FOR THE BAG VOLUME AND HAVE BEEN INCLUDING THE 10% OVERFILL. THE SALES REPRESENTATIVE ADVISED THAT THEY SHOULD INFUSE ONLY FOR THE CORRECT VOLUME AND THEN RE-RUN THE INFUSION IF THERE ARE RESIDUAL AMOUNTS IN THE BAG. THE CUSTOMER STRESSED THAT SALINE WORKS FINE, BUT IT IS WHEN THEY USE CISPLATIN AND LEUCOVORIN THAT THEY ENCOUNTER THE ISSUE. THE THREE SERIAL NUMBERS WERE REPORTED AS (B)(6). TWO OF THE PUMPS MALFUNCTIONED ONE TIME, AND ONE OF THE PUMPS MALFUNCTIONED THREE TIMES. THE REPORTED EVENT OCCURRED THREE TIMES WITH THE USE OF SERIAL NUMBER (B)(6). THIS REPORT IS FOR EVE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20684429 ↗MalfunctionNov 14, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
VISTA BASIC PUMP DID NOT ALARM FOR AIR THAT WENT PAST PUMP TO PATIENT, ON A COUPLE OF OCCASIONS INFUSING CISPLATIN AND LEUCOVORIN THE PUMP DID NOT ALARM FOR AIR ALMOST REACHING THE PATIENT. THE THREE SERIAL NUMBERS WERE REPORTED AS (B)(6) (3 EVENTS). TWO OF THE PUMPS MALFUNCTIONED ONE TIME, AND ONE OF THE PUMPS MALFUNCTIONED THREE TIMES. THIS REPORT IS FOR SERIAL NUMBER (B)(6). REFER TO MANUFACTURER REPORT 9610825-2024-00805 FOR SERIAL NUMBER (B)(6). REFER TO MANUFACTURER REPORTS 9610825-2024-00802 (B)(6) AND FOR THE THREE EVENTS INVOLVING SERIAL NUMBER (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20683990 ↗MalfunctionNov 12, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
VISTA BASIC PUMP DID NOT ALARM FOR AIR THAT WENT PAST PUMP TO PATIENT, ON A COUPLE OF OCCASIONS INFUSING CISPLATIN AND LEUCOVORIN THE PUMP DID NOT ALARM FOR AIR ALMOST REACHING THE PATIENT. THE THREE SERIAL NUMBERS WERE REPORTED AS (B)(6) (3 EVENTS), (B)(6) & (B)(6). TWO OF THE PUMPS MALFUNCTIONED ONE TIME, AND ONE OF THE PUMPS MALFUNCTIONED THREE TIMES. REPORT FOR SERIAL # (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20662219 ↗MalfunctionOct 31, 2024Failure to Charge; Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion; Failure to Charge; Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion
AS REPORTED BY THE USER FACILITY: UNIT REPORTED TO BE CAUSING INACCURATE INFUSION RATES AND NEEDING A BATTERY REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20577398 ↗
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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