ARROW IPN000329Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 30801902051739), received between Aug 2, 2018 and Jan 31, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2024Leak/Splash; Leak/Splash

  THE REPORT STATES THAT WHILE IN USE ON A PATIENT, THE PUMP EXPERIENCED "[HELIUM] LOSS, LEAK. PATIENT WAS NOT HARMED". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR 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 18616226 ↗
• MalfunctionAug 30, 2022No Display/Image; No Display/Image

  IT WAS REPORTED "IABP FAILURE. DURING TRANSPORT THE IABP THERAPY SCREEN BECAME INOPERABLE. WHILE LOADING THE PATIENT INTO THE AMBULANCE FOR TRANSIT TO THE REMOTE LANDING ZONE THE IABP SCREEN FLASHED ONCE BLANK BUT IMMEDIATELY RETURNED, ALL CONNECTIONS WERE ASSESSED AND DEEMED TO BE APPROPRIATE. AFTER LOADING THE PATIENT INTO THE AIRCRAFT AND PRIOR TO START UP THE SCREEN AGAIN WENT BLANK AND ALL CONTROL WAS LOST, THIS TIME THE IABP ACTUALLY STOPPED ASSISTING, DURING TROUBLE SHOOTING THE IABP STARTED TO TRIGGER SPONTANEOUSLY AND APPEARED TO CORRESPOND WITH THE CARDIAC RHYTHM ON THE ZOLL MONITOR. THERE WAS A BRIEF PERIOD OF HYPOTENSION AND BRADYCARDIA THAT WAS SELF-LIMITING AND RETURNED TO NORMAL WITHOUT THERAPY. [PHYSICIAN] WAS CONTACTED AND ON THE PHONE WHILE TROUBLE SHOOTING AND RETURN OF MECHANICAL ASSIST BUT NO ACTIVE THERAPY SCREEN. HE ADVISED TO CONTINUE TO UPMC SHADYSIDE. UPON LANDING AT UPMC SHADYSIDE, THE CTICU STAFF AND AN IABP WAS ON THE HELIPAD AND AN IMMEDIATE SWAP OF MACHINE WAS DONE WHILE THE PATIENT REMAINED IN THE AIRCRAFT. THERE WERE NO FURTHER INSTANCES OF HEMODYNAMICAL INSTABILITY". ADDITIONAL INFORMATION RECEIVED STATED THAT "THERE WAS NO INTERVENTION. THE PUMP S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15325279 ↗
• MalfunctionAug 30, 2022Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED "IABP FAILURE. DURING TRANSPORT THE IABP THERAPY SCREEN BECAME INOPERABLE. WHILE LOADING THE PATIENT INTO THE AMBULANCE FOR TRANSIT TO THE REMOTE LANDING ZONE THE IABP SCREEN FLASHED ONCE BLANK BUT IMMEDIATELY RETURNED, ALL CONNECTIONS WERE ASSESSED AND DEEMED TO BE APPROPRIATE. AFTER LOADING THE PATIENT INTO THE AIRCRAFT AND PRIOR TO START UP THE SCREEN AGAIN WENT BLANK AND ALL CONTROL WAS LOST, THIS TIME THE IABP ACTUALLY STOPPED ASSISTING, DURING TROUBLE SHOOTING THE IABP STARTED TO TRIGGER SPONTANEOUSLY AND APPEARED TO CORRESPOND WITH THE CARDIAC RHYTHM ON THE ZOLL MONITOR. THERE WAS A BRIEF PERIOD OF HYPOTENSION AND BRADYCARDIA THAT WAS SELF-LIMITING AND RETURNED TO NORMAL WITHOUT THERAPY. [PHYSICIAN] WAS CONTACTED AND ON THE PHONE WHILE TROUBLE SHOOTING AND RETURN OF MECHANICAL ASSIST BUT NO ACTIVE THERAPY SCREEN. HE ADVISED TO CONTINUE TO UPMC SHADYSIDE. UPON LANDING AT UPMC SHADYSIDE, THE CTICU STAFF AND AN IABP WAS ON THE HELIPAD AND AN IMMEDIATE SWAP OF MACHINE WAS DONE WHILE THE PATIENT REMAINED IN THE AIRCRAFT. THERE WERE NO FURTHER INSTANCES OF HEMODYNAMICAL INSTABILITY". ADDITIONAL INFORMATION RECEIVED STATED THAT "THERE WAS NO INTERVENTION. THE PUMP S

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension

  MAUDE report 15325275 ↗
• MalfunctionFeb 4, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PUMP SHUT DOWN WHILE RUNNING ON BATTERY POWER. THE PUMP ALARMED MULTIPLE TIMES RELATING TO HELIUM LOSS. THE PUMP WAS SWAPPED AT THE DESTINATION. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13451122 ↗
• MalfunctionFeb 4, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE PUMP SHUT DOWN WHILE RUNNING ON BATTERY POWER. THE PUMP ALARMED MULTIPLE TIMES RELATING TO HELIUM LOSS. THE PUMP WAS SWAPPED AT THE DESTINATION. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13451095 ↗
• MalfunctionOct 26, 2020Battery Problem; Battery Problem

  IT WAS REPORTED THAT INTRA-AORTIC BALLOON PUMP (IABP) HAD A PRECIPITOUS DROP IN BATTERY POWER WHILE ON PATIENT WHEN EXITING THE HELICOPTER AND THE STAFF QUICKLY PLUGGED THE IABP TO AN OUTLET. AS A RESULT, THE IABP WAS SWAPPED OUT WITH THE HOSPITAL'S IABP. THE PATIENT HAD NO ADVERSE OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10733985 ↗
• MalfunctionJul 15, 2020Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THE INTRA-AORTIC BALLOON PUMP (IABP) WAS IN USE AND THE STAFF EXPERIENCED A WHITE SCREEN AND POWERED DOWN DURING PATIENT CARE. THIS CONTINUED TO HAPPEN ON BOTH BATTERY AND PLUGGED IN. THE IABP DID MAKE AN AUDIBLE ALARM BUT NO WARNINGS CAME ACROSS THE SCREEN. AS A RESULT, THE IABP WAS SWAPPED OUT AT THE HOSPITAL. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10275565 ↗
• MalfunctionAug 2, 2018Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED BY THE FIELD SERVICE ENGINEER (FSE) THAT "WHILE ON PATIENT THE DISPLAY WOULD FREEZE AND GO BLANK WHILE PRESSING KEYS ON THE MONITOR. THE INTRA-AORTIC BALLOON PUMP (IABP) WAS SWAPPED AND THE PATIENT WAS NOT HARMED. AFTER THE SWAP, CATH LAB TRIED RUNNING THE PUMP ON THE SIMULATOR AND RECEIVED "UNABLE TO REFILL" ALARM ERROR MESSAGE." THE FSE FOUND WHILE PUMPING WITH THE CUSTOMER'S BALLOON SIMULATOR, ABNORMAL BALLOON WAVEFORM AND CLICKING SOUND THEN "UNABLE TO REFILL" ALARM. THE FSE ALSO FOUND THIS BALLOON SIMULATOR NOT PROPERLY INFLATED. PROPERLY INFLATING THE BALLOON SIMULATOR FIXED THE PROBLEM. COULD NOT REPLICATE SCREEN FREEZING TO ENSURE SUCCESSFUL REPAIR. THE DISPLAY UMBILICAL CORD IS REPLACED. THE IABP PERFORMED TO SPECIFICATION. THERE WAS NO REPORTED PATIENT DEATH, SERIOUS INJURY OR COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7744901 ↗

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-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-0426-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump
• Z-0444-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400E (IPN000305), 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-0427-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), 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-0456-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), 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-0447-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D (IPN000321), 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-0449-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500EX (IPN000322), 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-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-0454-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), 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

…and 14 more.