ARROW IPN000325Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 30801902043420), received between Aug 30, 2018 and May 1, 2024 — classified as 44 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (15 reports).

29 other recalls cover devices cleared under the same FDA submission (K060309); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2024Connection Problem; Output Problem; Connection Problem; Output Problem

  IT WAS REPORTED " IT WAS REPORTED THAT A REFILL ERROR OCCURRED AND IT WAS IMPOSSIBLE TO INPUT EXTERNAL ECG DURING USE AC2. THEREFORE, THE AC2 WAS REPLACED TO ANOTHER PUMP OF NOT-TELEFLEX". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226108 ↗
• MalfunctionMay 1, 2024Device Alarm System; Connection Problem; Device Alarm System; Connection Problem

  IT WAS REPORTED "IT WAS REPORTED THAT A REFILL ERROR OCCURRED AND IT WAS IMPOSSIBLE TO INPUT EXTERNAL ECG DURING USE AC2. THEREFORE, THE AC2 WAS REPLACED TO ANOTHER PUMP OF NOT-TELEFLEX". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226107 ↗
• MalfunctionMay 19, 2023Image Display Error/Artifact; Image Display Error/Artifact

  IT WAS REPORTED THAT "WHEN THE IABP WAS USED DURING AN EMERGENCY CATHETER SURGERY, THE MONITOR IMAGE BLURRED AND [STAFF] COULD NOT SEE WELL. THEREFORE, THE USER REPLACED THE IABP WITH A PUMP OF ANOTHER COMPANY TO COMPLETE THE SURGERY". NO PATIENT HARM OR INJURY. PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16964471 ↗
• MalfunctionMay 19, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, "THE CATHETER SENSOR ERROR OCCURRED" ON THE IABP. AS A RESULT, THE IABP WAS SWAPPED OUT WITH ANOTHER, "THEN THE SENSOR WORKED NORMALLY". NO PATIENT HARM OR INJURY. PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16961994 ↗
• MalfunctionMay 15, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE ALARM MESSAGE OF THE HELIUM SUPPLY SHORTAGE OCCURRED, IN SPITE THAT THE HELIUM RESIDUAL PRESSURE WAS SUFFICIENT. OUR TECHNICAL SPECIALIST TOLD THE CUSTOMER TO REPLACE THE HELIUM WASHER AND THE BALLOON CONNECTOR. AFTER THAT, THE CONDITION OF THE IABP WAS STABLE". THE IABP WAS NOT SWITCHED OUT. NO PATIENT HARM OR INJURY. PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16933446 ↗
• MalfunctionOct 18, 2022Gas/Air Leak; Gas/Air Leak

  THE REPORT STATES THAT "THE "HELIUM LOSS ALARM (2)" WENT OFF DURING USE ON A PATIENT. THEREFORE, THE IABP WAS REPLACED WITH ANOTHER ONE IN THE FACILITY, BY WHICH THE ALARM STOPPED". PATIENT CONDITION REPORTED AS "FINE". NO REPORT OF DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15627769 ↗
• MalfunctionOct 18, 2022Pumping Stopped; Pumping Stopped

  THE REPORT STATES "AFTER 17:00 ON (B)(6) 2022, AN URGENT PATIENT CAME AND AN IAB WAS INSERTED. ABOUT 23:00, WHILE DRIVING IABP, THE SCREEN SUDDENLY FROZE, AND PUMPING STOPPED. THE USER PUSHED THE BUTTON, BUT IT DID NOT WORK AT ALL, SO THE USER TURNED OFF THE POWER ONCE AND RESTARTED, THEN THE DRIVE RESUMED. ABOUT 0:30 ON (B)(6) 2022, ABOUT 1 HOUR AFTER RESTART, PUMPING STOPPED AGAIN. THE SCREEN DID NOT FREEZE BUT PUSHING THE BUTTON DID NOT WORK. THEREFORE, IABP WAS REPLACED WITH ANOTHER ONE IN THE FACILITY". NO REPORT OF PATIENT HARM OR INJURY. ASSOCIATED MDR 3010532612-2022-00436.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15627132 ↗
• MalfunctionOct 18, 2022Pumping Stopped; Pumping Stopped

  THE REPORT STATES "AFTER 17:00 ON (B)(6) 2022, AN URGENT PATIENT CAME AND AN IAB WAS INSERTED. ABOUT 23:00, WHILE DRIVING IABP, THE SCREEN SUDDENLY FROZE, AND PUMPING STOPPED. THE USER PUSHED THE BUTTON, BUT IT DID NOT WORK AT ALL, SO THE USER TURNED OFF THE POWER ONCE AND RESTARTED, THEN THE DRIVE RESUMED. ABOUT 0:30 ON 03 OCT 2022, ABOUT 1 HOUR AFTER RESTART, PUMPING STOPPED AGAIN. THE SCREEN DID NOT FREEZE BUT PUSHING THE BUTTON DID NOT WORK. THEREFORE, IABP WAS REPLACED WITH ANOTHER ONE IN THE FACILITY". NO REPORT OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15627009 ↗
• MalfunctionAug 11, 2022Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT "THE PUMP HAD BEEN USED FROM JULY 5. ON JULY 10 AT 14:16, THE CODE 26 ALARM WENT OFF. THE ALARM SOUND STOPPED BY PUSHING THE RESET BUTTON, BUT IT WENT OFF AGAIN AFTER 20 - 30 MIN. THERE WAS A TURBID LIQUID ABOUT 1/3 IN THE BOTTLE. THE LIQUID WAS DRAINED, BUT THE ALARM WENT OFF AGAIN. ABOUT 3 MM OF LIQUID ACCUMULATED IN 3 HOURS AFTER THE LIQUID WAS DRAINED. THE CATHETER WAS OPERATING WITHOUT ANY PROBLEMS. AT 15:13, BLOOD CAME INTO THE CATHETER. THE PUMP WAS REPLACED WITH A NEW ONE". ADDITIONAL RECEIVED STATED THAT THE CATHETER WAS A NON-TELEFLEX DEVICE. PATIENT CONDITION "UNKNOWN" AT TIME OF REPORT.

  Patient problems: Insufficient Information

  MAUDE report 15208908 ↗
• MalfunctionJul 16, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AN "UNABLE TO REFILL" ALARM WENT OFF DURING CLINICAL USE WITH ECMO. AFTER CONFIRMING THE ALARM, THE USER ATTEMPTED TO PRESS THE DRIVE START KEY BUT COULD NOT. HE/SHE TRIED TO RESTART THE INTRA-AORTIC BALLOON PUMP (IABP) BY NR. ME, BUT THE IABP DID NOT RESTART. THEREFORE, THE IABP WAS REPLACED WITH A BACK-UP ONE IN THE FACILITY. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH. THE TECHNICAL ENGINEER OF DVX, THE DISTRIBUTOR, VISITED TO THE FACILITY AND CONFIRMED OPERATION OF THE IABP USING THE SIMULATOR SET IN THE EICU EQUIPMENT ROOM. LEAK TEST, VARIOUS SIGNAL INPUT CONFIRMATION, SWITCHING OPERATION / DRIVE CONFIRMATION, DRAIN / REFILL OPERATION: ALL NORMAL OPERATIONS WERE CONFIRMED. IT WAS UNKNOWN WHETHER THE ALARM SOUND WAS CANCELLED BY PRESSING THE RESET KEY WHEN THE ALARM WENT OFF. ADDITIONAL INFORMATION RECEIVED: THERE WAS A REPORT OF PATIENT DEATH AN UNKNOWN AMOUNT OF TIME AFTER THE REPORTED EVENT. THERE WAS NO DELAY IN THERAPY AND NO ALLEGED DEVICE CONTRIBUTION TO THE PATIENT'S DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12180489 ↗
• MalfunctionJun 30, 2021Mechanical Problem; Mechanical Problem

  THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT DURING PRODUCT TRAINING/DEMONSTRATION, THE ALARM OF SYSTEM ERROR 3 WENT OFF AFTER PUMPING STARTED. THE USER TRIED TO RESTART THE PUMPING BY TURNING OFF AND ON THE MAIN POWER SWITCH; HOWEVER, THE SAME ALARM WENT OFF IMMEDIATELY. THE ALARM WENT OFF ABOUT 5 TIMES IN THE END. A TECHNICAL SPECIALIST IS SCHEDULED TO VISIT THE FACILITY FOR INSPECTION OF THE INTRA-AORTIC BALLOON PUMP (IABP).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12091787 ↗
• MalfunctionMay 5, 2021Battery Problem; Battery Problem

  THERE WAS NO PATIENT INVOLVEMENT. DURING SERVICE IT WAS FOUND THAT THE INTRA-AORTIC BALLOON PUMP (IABP) WAS PUMPING BY FULL BATTERY FOR ONLY ABOUT 30 MINUTES. WHEN SHUTTING DOWN THE BATTERY, THE POWER WAS TURNED OFF AND ON SEVERAL TIMES. AS A RESULT, THE POWER SUPPLY UNIT AND RELATED WIRING CABLES WERE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11779799 ↗
• MalfunctionApr 22, 2021Mechanical Problem; Mechanical Problem

  THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT DURING OPERATIONAL CHECKING OF THE INTRA-AORTIC BALLOON PUMP (IABP) (BATTERY- OPERATED) AT THE DISTRIBUTOR'S SITE, AFTER ABOUT 60 MINUTES, A "LARGE HELIUM LEAK" ALARM AND "HIGH BASE LINE" ALARM OCCURRED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11706599 ↗
• MalfunctionFeb 16, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT WHEN THE USER ATTEMPTED TO START THE INTRA-AORTIC BALLOON PUMP (IABP) WITH USING THE INTRA-AORTIC BALLOON (IAB), A PURGE ALARM OCCURRED AND THE IABP DIDN'T START WORKING. AS A RESULT, A BACK-UP IABP WAS USED WITHOUT ANY ISSUES. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11332746 ↗
• MalfunctionJan 6, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT WHEN THE INTRA-AORTIC BALLOON PUMP (IABP) WAS IN USE ON A PATIENT, THE STAFF EXPERIENCED A HELIUM LOSS ALARM (3). AS A RESULT, THE IABP WAS REPLACED. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11124590 ↗
• MalfunctionJan 6, 2021Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON PUMP (IABP) HAD A SYSTEM ERROR 1 WHILE IN USE ON A PATIENT. DESPITE THE ISSUE, THE STAFF CONTINUED TO USE THE IABP, AND POWERED ON/OFF THE IABP. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11123681 ↗
• MalfunctionNov 16, 2020Pumping Stopped; Gas/Air Leak; Pumping Stopped; Gas/Air Leak

  IT WAS REPORTED THAT HELIUM LOSS ALARMS FREQUENTLY OCCURRED AFTER THE INTRA-AORTIC BALLOON PUMP (IABP) INITIATED PUMPING, 15 MINUTES LATER PUMPING STOPPED FREQUENTLY. AS A RESULT, THE IABP WAS REPLACED WITH A BACKUP IABP AND THE PROCEDURE CONTINUED SUCCESSFULLY. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10842848 ↗
• MalfunctionAug 26, 2020Power Problem; Power Problem

  IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON PUMP (IABP) SWITCHED TO BATTERY POWER DESPITE BEING PLUGGED IN WHILE IN USE. AS A RESULT, THE IABP WAS SWAPPED OUT FOR ANOTHER IABP. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10454306 ↗
• MalfunctionJun 18, 2020Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE SCREEN OF THE INTRA-AORTIC BALLOON PUMP (IABP) WAS FROZEN FOR A FEW TENS OF SECONDS. PUMPING DID NOT STOP. AS A RESULT, THE IABP WAS REPLACED WITH A NEW ONE. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10169477 ↗
• MalfunctionFeb 21, 2020Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE "UNABLE TO REFILL" ALARM OCCURRED DURING USE ON A PATIENT AND THE INTRA-AORTIC BALLOON PUMP (IABP) STOPPED WORKING. WHEN THE HOSPITAL STAFF RESTARTED THE DEVICE, IT WORKED NORMALLY. THEREFORE, THEY DECIDED TO CONTINUE USING THE PUMP WITH MONITORING. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9739330 ↗
• MalfunctionFeb 19, 2020Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT SOON AFTER PLACEMENT OF THE INTRA-AORTIC BALLOON CATHETER (IABC), PREMATURE VENTRICULAR CONTRACTION (PVC) OCCURRED CONTINUOUSLY AND HELIUM LOSS ALARM OCCURRED FREQUENTLY. THEN AS THE PATIENT'S ARRHYTHMIA RECEDED, THE ALARMS STOPPED. A SHORT TIME LATER, THE PATIENT'S AORTIC PRESSURE BEGAN TO REDUCE AND THE HELIUM LOSS ALARMS OCCURRED FREQUENTLY, AGAIN. THE HOSPITAL STAFF REBOOTED THE INTRA-AORTIC BALLOON PUMP (IABP) AND CHECKED ALL CONNECTIONS, BUT THE ALARMS PERSISTS. AS THE PATIENT'S CONDITION BECAME WORSE, THE STAFF ACTIVATED THE IABP BY INTERNAL TRIGGER MODE, WHICH STOPPED THE ALARM. THERE WAS NO REPORT OF PATIENT INJURY OR CONSEQUENCE. PATIENT OUTCOME REPORTED AS FINE.

  Patient problems: Arrhythmia; Low Blood Pressure/ Hypotension; No Consequences Or Impact To Patient

  MAUDE report 9729656 ↗
• MalfunctionFeb 14, 2020Moisture or Humidity Problem; Moisture or Humidity Problem

  IT WAS REPORTED THAT "DRAIN ERROR" ALARM OCCURRED FREQUENTLY WHILE IN USE ON A PATIENT. IT WAS POSSIBLE TO CONTINUE TO USE THE INTRA-AORTIC BALLOON PUMP (IABP), HOWEVER, THE USER HAD TO RESET THE ALARM EACH TIME IT OCCURRED. AS A RESULT, THE PUMP WAS REPLACED WITH A BACK-UP PUMP. THERE WAS NO REPORT OF DELAY IN THERAPY. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9712437 ↗
• MalfunctionFeb 5, 2020Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON PUMP (IABP) HAD A SYSTEM ERROR 7 DURING INSPECTION/FUNCTIONAL TESTING. IT WAS NOTED THAT THE USER INSERTED/REMOVED THE UMBILICAL CABLE REPEATEDLY, BUT THE ALARM RECURRED. AS A RESULT, THE IABP WAS REPLACED WITH A BACK-UP ONE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9672813 ↗
• MalfunctionJan 16, 2020Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT ALARM SYSTEM ERROR 7 WENT OFF WHILE IN USE ON A PATIENT. AS A RESULT, THE INTRA-AORTIC BALLOON PUMP (IABP) WAS REPLACED BY A BACK-UP ONE. THERE WAS NO REPORT OF DELAY IN THERAPY. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9595920 ↗
• MalfunctionDec 13, 2019Noise, Audible; Noise, Audible

  IT WAS REPORTED THE INTRA-AORTIC BALLOON PUMP (IABP) BEGAN PUMPING AND THE STAFF HEARD CLICKING NOISES. THE NOISE BECAME LOUDER AND CONTINUED FOR ABOUT AN HOUR. AS A RESULT, THE PUMP WAS STOPPED AND WAS SWAPPED OUT. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9468477 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060309. One submission often covers many models, so check the product and lot details in each record.

• Z-0448-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500E (IPN000322), cardiac pump
• Z-0428-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump
• Z-0454-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac pump
• Z-0429-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), cardiac pump
• Z-0449-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500EX (IPN000322), cardiac pump
• Z-0453-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump
• Z-0426-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump
• Z-0456-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), cardiac pump
• Z-0431-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump
• Z-0445-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400F (IPN000306), cardiac pump
• Z-0447-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D (IPN000321), cardiac pump
• Z-0450-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), cardiac pump
• Z-0455-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac pump
• Z-0432-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump
• Z-0451-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500I (IPN000324), cardiac pump

…and 14 more.