ARROW IPN917285Recalls & reported problems

Summary

The FDA's MAUDE database contains 148 adverse event reports that list this exact device (DI 10801902172065), received between Aug 15, 2022 and Feb 12, 2026 — classified as 148 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (25 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 148 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Inflation Problem

  IT WAS REPORTED "AFTER THE CATHETER INSERTED, THE BALLOON CAN NOT INFLATE COMPLETELY, CHANGE THE NEW CATHETER.". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322317 ↗
• MalfunctionAug 17, 2023Gas/Air Leak; Gas/Air Leak

  THE REPORT STATES, "IABP HAD LEAK ALARMS AND WHEN TANK WAS EXCHANGED, TANK EMPTIED WITHIN MINUTES". AS A RESULT, THE PUMP WAS SWITCHED OUT FOR ANOTHER. THERE WAS NO DELAY IN THERAPY. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17564265 ↗
• MalfunctionAug 11, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT WHILE IN USE ON PATIENT(S), "3 OF THEIR 6 PUMPS HAVE SHUT OFF, COULD BE BATTERY PROBLEM OR BATTERY'S NOT BE CHARGED". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED. ASSOCIATED MDRS #3010532612-2023-00440 AND 3010532612-2023-00442.

  Patient problems: Insufficient Information

  MAUDE report 17510071 ↗
• MalfunctionAug 11, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT WHILE IN USE ON PATIENT(S), "3 OF THEIR 6 PUMPS HAVE SHUT OFF, COULD BE BATTERY PROBLEM OR BATTERY'S NOT BE CHARGED". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 17510001 ↗
• MalfunctionAug 11, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT WHILE IN USE ON PATIENT(S), " 3 OF THEIR 6 PUMPS HAVE SHUT OFF, COULD BE BATTERY PROBLEM OR BATTERY'S NOT BE CHARGED". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 17509976 ↗
• MalfunctionAug 10, 2023Communication or Transmission Problem; Communication or Transmission Problem

  REPORTED DURING START UP WHILE IN USE ON A PATIENT AS "SYSTEM ERROR 8, FOS FAILURE". AS A RESULT, THE PUMP WAS SWITCHED OUT FOR ANOTHER. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17503689 ↗
• MalfunctionAug 2, 2023Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE PUMP ALARMED "SYSTEM ERROR 3". AS A RESULT, THE PUMP WAS SWITCHED OUT FOR ANOTHER. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17444515 ↗
• MalfunctionAug 1, 2023Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED THAT "PUMP LOST POWER DURING PATIENT TRANSPORT." AS A RESULT, THE PUMP WAS SWITCHED OUT FOR ANOTHER. NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17437807 ↗
• MalfunctionJul 25, 2023Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED THAT "THE PUMP SHUT OFF DURING TRANSPORT. AS A RESULT, THE PUMP WAS SWAPPED OUT WITH NO COMPLICATIONS TO THE PATIENT. FIELD SERVICE REP. COULD NOT FIND ANYTHING WRONG WITH THE PUMP. RAN BATTERY LOAD TEST, UNIT PASSES WITH 11.9 V AFTER 1 HOUR. PERFORMED FUNCTIONAL CHECK OUT, NO PROBLEMS FOUND. UNIT CHECKS OK". NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17392742 ↗
• MalfunctionJul 18, 2023Output Problem; Output Problem

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, "ERRATIC TRIGGERING WITH GOOD SIGNALS, OCCURRING ON BOTH ECG AND AP- PUMP EXCHANGED". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17343638 ↗
• MalfunctionJul 12, 2023Power Problem; Power Problem

  THE REPORT STATES, "PUMP HAD PURGE FAILURE ALARM AND POWERED DOWN TWICE WHILE ON PATIENT". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 17309186 ↗
• MalfunctionJul 5, 2023Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED FROM THE BIOMEDICAL ENGINEERING DEPARTMENT THAT A PUMP WAS BROUGHT DOWN WITH A "NOTE THAT STATES THAT THE IABP DID NOT REGISTER ANY AP PRESSURES ON THE DISPLAY WHEN IT WAS IN USE". FURTHER INFORMATION STATES THAT "AP WORKS IN FOS, TRANSDUCER, AND MONITOR MODES. PERFORMED PM, NO PROBLEMS FOUND. UNIT CHECKS OUT OK". NO PATIENT HARM OR INJURY. THE CUSTOMER IS UNABLE TO ANSWER OUR REQUESTS FOR ADDITIONAL INFORMATION REGARDING THE PATIENT'S CURRENT STATUS OR HOW THE ISSUE WAS RESOLVED. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17263267 ↗
• MalfunctionJun 30, 2023Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED THAT "IABP HAS SHUT OFF A COUPLE TIMES WHILE ON A PATIENT. THE REGISTERED NURSE RN WAS ABLE TO RESTART THE IABP BY SWITCHING THE ON/OFF SWITCH OFF,THEN BACK ON. THE WHOLE CONSOLE WAS SHUTTING DOWN WITH NO WARNING. THIS MORNING WE SWAPPED OUT THE CONSOLE WITH A NEW ONE SO WE COULD BRING THE AFFECTED UNIT TO CE. THERE DIDN'T SEEM TO BE ANY INSTIGATING FACTOR CAUSING THE IABP TO SHUT DOWN." ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO IMPACT, HARM OR INJURY TO THE PATIENT. THE PATIENT STATUS IS REPORTED AS "RECEIVED A HEART TRANSPLANT THE NEXT DAY AND IS NO LONGER ON IABP SUPPORT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17240192 ↗
• MalfunctionJun 29, 2023Power Problem; Power Problem

  REPORTED AS "PUMP SHUT DOWN" WHILE IN USE ON A PATIENT IN THEIR ROOM. THE ISSUE WAS RESOLVED BY POWERING THE PUMP BACK ON "WITHIN SECONDS". THE USER ENDORSED THAT THEY DID NOT SEE ANY POWER RELATED ALARMS PRIOR TO THE PUMP SHUTTING DOWN. THE USER COULD NOT CONFIRM IF THE PUMP WAS PLUGGED INTO WALL POWER WHEN THE EVENT OCCURRED. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17230597 ↗
• MalfunctionJun 29, 2023Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT THE "PUMP UNRESPONSIVE AFTER HIGH PRIORITY ALARM". BOTH TOUCHSCREEN AND HARD KEYS WERE NOT FUNCTIONING. AS A RESULT, THE PUMP WAS POWER CYCLED WHICH RESOLVED THE ISSUE AND TOUCHSCREEN AND HARD KEYS THEN WORKED APPROPRIATELY. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17230053 ↗
• MalfunctionJun 29, 2023Communication or Transmission Problem; Communication or Transmission Problem

  REPORTED AS "SYSTOLIC VALUES AND DIASTOLIC VALUES READING AS SAME NUMBER". THE PATIENT WAS A TRANSFER FROM AN OUTSIDE FACILITY WITH A CLOTTED CENTRAL LUMEN ON A COMPETITOR IAB. ALTERNATE ARTERIAL ACCESS OBTAINED AND TRANSDUCED. TROUBLESHOOTING INCLUDED REPOSITIONING THE PATIENT, VERIFYING THE TRANSDUCER SIGNAL AND CONNECTIONS, REBOOTING IABP SCREEN, POWER CYCLING THE PUMP, AND ADJUSTING THE TIMING. NONE OF THESE MEASURES RESOLVED THE ISSUE. AS A RESULT, THE PUMP WAS SWITCHED OUT FOR A DIFFERENT PUMP. THE 2ND PUMP WAS MANUALLY TIMED WITH ONLY MINIMAL IMPROVEMENT. IAB VOLUME REDUCTION ATTEMPTED WITH NO IMPROVEMENT. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17225513 ↗
• MalfunctionJun 29, 2023Pumping Stopped; Pumping Stopped

  THE REPORT STATES THAT WHILE IN USE ON A PATIENT, THE "PUMP ALLEGEDLY STOPPED PUMPING AND DID NOT DIVERT TO AP SIGNAL WHILE IN AUTOPILOT MODE WHEN ECG LEADS WERE LOST". THE ISSUE WAS RESOLVED AS "BIOMEDICAL ENGINEERING PRESSED PUMP OFF ON SCREEN AND THEN PRESSED PUMP ON. ISSUE RESOLVED ITSELF". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17225369 ↗
• MalfunctionJun 29, 2023Device Alarm System; Insufficient Device Problem Information; Device Alarm System; Insufficient Device Problem Information

  REPORTED VIA A MEDWATCH REPORT. THE REPORT STATES, "IABP ALARMING. THE ALARM WAS "EKG TRIGGER LOSS". THE BALLOON WAS NOT INFLATING WITH EACH COMPLEX. A-LINE PRESSURES STABLE. THE IABP WAS ON "AUTOPILOT" AND EKG WAS SHOWING UP ON SCREEN. THE IABP STARTED ALARMING "HIGH PRESSURE" AND WAS ERRATICALLY INFLATING AND DEFLATING. ALL LINES RECHECKED AGAIN FROM THE PATIENT TO THE PUMP. NOTED NOTHING WRONG. THE HELIUM LINE THEN FLOODED WITH BLOOD. PATIENT WAS SEND TO THE OPERATING ROOM TO REPLACE THE BALLOON". COMPLAINT RECEIVED FROM FDA MEDWATCH VOLUNTARY REPORT. THE REPORTER ELECTED TO NOT BE IDENTIFIED, AND TELEFLEX IS UNABLE TO REQUEST ADDITIONAL INFORMATION. NO FURTHER COMPLAINT OR CUSTOMER DETAILS ARE AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17225284 ↗
• MalfunctionJun 29, 2023Pumping Stopped; Pumping Stopped

  THE REPORT STATES THAT WHILE IN USE ON A PATIENT DURING TRANSPORT FROM THE OR, THE "PUMP ALLEGEDLY STOPPED PUMPING IN AUTOPILOT MODE WHEN ECG AND PRESSURE SIGNALS WERE AVAILABLE". AS A RESULT, THE PUMP WAS SWAPPED OUT FOR ANOTHER. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17224591 ↗
• MalfunctionJun 28, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT PRIOR TO USE WHILE PREPARING A PUMP TO BE USED ON A PATIENT, THE BATTERY DRAINS FAST "ABOUT 20 MINUTES". NO PATIENT INVOLVEMENT. THE ISSUE WAS FIXED BY USING A DIFFERENT PUMP. NO IMPACT TO THE PATIENT, THE PATIENT STATUS IS REPORTED AS "GREAT", NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17217715 ↗
• MalfunctionJun 28, 2023Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT AFTER THE PATIENT HAD BEEN ON THE PUMP FOR 45 DAYS, THE PUMP STARTED "MAKING AUDIBLE CLICKING NOISE WHEN PUMPING WITH CHANGES TO BPW". TROUBLESHOOTING INCLUDED 2 MANUAL PURGES AND EMPTYING OF THE CONDENSATION BOTTLE WHICH RESOLVED THE PROBLEM BUT ONLY FOR APPROXIMATELY 15-20 SECONDS, THEN THE CLICKING RESUMED. AS A RESULT, THE PUMP WAS EXCHANGED FOR ANOTHER PUMP. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17215961 ↗
• MalfunctionJun 14, 2023Failure to Charge; Battery Problem; Failure to Charge; Battery Problem

  IT WAS REPORTED THAT DURING ROUTINE DEVICE CHECK, THE PUMP BATTERY WAS NOT CHARGING. THE GREEN POWER INDICATOR LIGHT WAS ON, BUT THE YELLOW CHARGE INDICATOR LIGHT WAS NOT. THE PUMP HAD BEEN PLUGGED INTO AC POWER FOR SEVERAL DAYS PRIOR TO THIS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17128268 ↗
• MalfunctionJun 9, 2023Failure to Run on Battery; Complete Loss of Power; Failure to Run on Battery; Complete Loss of Power

  IT WAS REPORTED THAT WHILE ON BATTERY POWER DURING USE ON A PATIENT TRANSPORTING FROM THE CCU TO CT AND BACK TO THE CCU, THE BATTERY FAILED AND THE PUMP SUFFERED A COMPLETE LOSS OF POWER. AS A RESULT, THE PUMP WAS EXCHANGED FOR ANOTHER PUMP. NO PATIENT HARM OR INJURY. THE INITIAL PUMP HAD BEEN PLUGGED INTO AC POWER, PER IFU. WHEN UNPLUGGED, THE PUMP IMMEDIATELY AND INACCURATELY DISPLAYED "BATTERY LIFE LESS THAN " 20 MIN, 10 MIN, AND 5 MIN IN A ROW WITHIN SECONDS. THE PUMP DID NOT LAST ON BATTERY POWER PER THE INDICATED TIME LEFT. THE PATIENT STATUS WAS REPORTED AS "CRITICAL" PRIOR TO THE PUMP BATTERY FAILURE. PATIENT CONDITION UNCHANGED BY EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097300 ↗
• MalfunctionJun 5, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE PUMP HAD CONSTANT HELIUM LOSS ALARMS WHEN ON A PATIENT. AS A RESULT, THE PUMP WAS SWAPPED OUT FOR ANOTHER. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17059822 ↗
• MalfunctionJun 2, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING MORNING QUALITY CHECK, THE PUMP WAS UNPLUGGED TO ASSESS BATTERY PERFORMANCE. WHEN THE PUMP WAS UNPLUGGED, IT SHUT OFF. THE USER DENIES ANY BATTERY ALARMS AND STATES THAT THE PUMPS ARE PLUGGED IN CONTINUOUSLY. NO PATIENT INVOLVEMENT. AS A RESULT, "REPLACED POWER SUPPLY, THEY HAD DISPLAY ISSUES. REPLACED CPM. FOUND UMBILICAL CABLE HEATH HAD PULLED AWAY FROM CONNECTION, REPLACED CABLE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17049720 ↗