ARROW IPN000324Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 30801902092190), received between Oct 19, 2018 and Apr 25, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2024Battery Problem; Battery Problem

  IT WAS REPORTED " THE IABP DOESN'T WORK, LOW BATTERY ALARM". ADDITIONALLY IT IS STATED THAT THIS ISSUE HAPPENED PRIOR TO USE. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19187836 ↗
• MalfunctionMar 6, 2024Failure to Run on Battery; Failure to Run on Battery

  THE REPORT STATES WHILE IN USE ON A PATIENT, "INTERNAL BATTERY DOESN'T WORK AND THE PUMP DOES NOT WORK DETACHED BY THE MAIN LINE". THE ISSUE WAS RESOLVED BY "USING THE PUMP CONNECTING TO THE MAIN LINE". THERE WAS NO PATIENT HARM OR INJURY OR DELAY IN THERAPY. NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18845488 ↗
• MalfunctionJan 12, 2024Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT DURING USE ON A PATIENT "IABP STOPPED PUMPING. THERAPY HAS BEEN COMPLETED BY SWITCHING TO ANOTHER AVAILABLE PUMP". ADDITIONAL INFORMATION RECEIVED STATES "NO ADVERSE PATIENT CONDITION HAS BEEN REPORTED BY THE CUSTOMER". THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18502925 ↗
• MalfunctionNov 10, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE MACHINE DISPLAYED HELIUM LOSS ALARM WHILE PUMPING DURING PREVENTATIVE MAINTENANCE. NO REPORT OF PATIENT INV OLVEMENT. THE PNEUMATIC CONTROL SYSTEM HAS BEEN REPLACED. THE MACHINE WAS RETURNED TO SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15772991 ↗
• MalfunctionJul 7, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE MACHINE DISPLAYED HELIUM LOSS ALARM WHILE PUMPING DURING PREVENTIVE MAINTENANCE. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14941233 ↗
• MalfunctionSep 16, 2021Gas/Air Leak; Gas/Air Leak

  THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT HELIUM LEAKAGE ALARM OCCURRED RIGHT AFTER PUMPING STARTED DURING CORRECTIVE ACTION. IT WAS NOTED THE MACHINE WAS UNABLE TO PUMP, IT SYSTEMATICALLY WENT TO ALARM. AS A RESULT, THE INTERFACE BLOCK AND PCS ASSEMBLY WERE REPLACED, AND THE MACHINE WAS RETURNED TO SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12480290 ↗
• MalfunctionAug 18, 2021Gas/Air Leak; Gas/Air Leak

  THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT "HELIUM LEAKAGE" OCCURRED DURING SERVICE. THE INTRA-AORTIC BALLOON PUMP (IABP) HAS NOT BEEN USED SINCE APRIL. AS A RESULT, THE PUMP ASSEMBLY WAS REPLACED, AND THE IABP WAS RETURNED TO SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12338484 ↗
• MalfunctionJan 26, 2021Infusion or Flow Problem; Infusion or Flow Problem

  THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, THE SERVICE ENGINEER DETECTED A PURGE FAILURE. AS A RESULT, THE PCS WAS REPLACED AND THE INTRA-AORTIC BALLOON PUMP (IABP) WAS PLACED BACK INTO SERVICE.

  Patient problems: No Patient Involvement

  MAUDE report 11230155 ↗
• MalfunctionOct 28, 2020Power Problem; Power Problem

  THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON PUMP (IABP) FAILED TO SWITCH ON. AS A RESULT, A NEW IABP WAS USED.

  Patient problems: No Patient Involvement

  MAUDE report 10750158 ↗
• MalfunctionAug 20, 2020Detachment of Device or Device Component; Mechanical Jam; Noise, Audible; Detachment of Device or Device Component; Mechanical Jam; Noise, Audible

  IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON PUMP (IABP) HAD A HIGH BASELINE ALARM WHILE ON PATIENT AND IT WAS NOTED THE PUMP ASSEMBLY WAS "NOISY". AS A RESULT, THE IABP WAS SWAPPED OUT FOR ANOTHER IABP. THERE WAS NO INFORMATION REGARDING PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 10431522 ↗
• MalfunctionAug 14, 2020Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT WHEN THE INTRA-AORTIC BALLOON PUMP (IABP) WAS IN USE THE STAFF NOTED THERE WAS NO AP SIGNAL COMING FROM THE FLUID FILL TRANSDUCER. AS A RESULT, THE IABP WAS SWAPPED OUT. THERE WAS NO PATIENT OUTCOME REPORTED BY THE HOSPITAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10408237 ↗
• MalfunctionApr 5, 2019Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT WHEN THE INTRA-AORTIC BALLOON PUMP (IABP) PUMP WAS IN USE, THE STAFF EXPERIENCED A HELIUM LOSS ALARM. THE USER ALSO NOTED THAT THE HELIUM GAS IN THE TANK WAS DECREASING QUICKLY. AS A RESULT, THE PUMP WAS REPLACED BY A BACK-UP. THERE WAS NO REPORT OF DELAY IN THERAPY. THERE WAS NO REPORT OF PATIENT COMPLICATION OR SERIOUS INJURY AND DEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8488674 ↗
• MalfunctionApr 2, 2019Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT WHEN THE INTRA-AORTIC BALLOON PUMP (IABP) WAS IN USE, THE PUMP ALARMED FOR "LOW HELIUM". THE STAFF NOTED THAT THEY WERE HAVING A LEAKING PROBLEM, WHICH LEAD THEM TO USE 2 HELIUM CANISTERS FOR A 24-HOUR THERAPY. THERE WAS NO REPORTED PROBLEM WITH THERAPY DELIVERY. AS A RESULT, THE HELIUM CANISTER WAS REPLACED TO THE END OF THERAPY. THERE WAS NO REPORT OF DELAY IN THERAPY. THERE WAS NO REPORT OF PATIENT COMPLICATION OR SERIOUS INJURY AND DEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8473203 ↗
• MalfunctionOct 19, 2018Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON PUMP (IABP) WAS DISPLAYING A "POSSIBLE HELIUM LEAK" THE IABP HAS BEEN EXCHANGED WITH A FUNCTIONING ONE. THERE WAS NO REPORT OF PATIENT DEATH, SERIOUS INJURY OR COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7984717 ↗

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-0456-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), 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
• Z-0454-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), 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-0446-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), cardiac pump
• Z-0427-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), 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-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-0452-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000325), cardiac pump
• Z-0430-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000328), cardiac pump
• Z-0428-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), 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-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-0426-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump

…and 14 more.