ARROW IPN039787Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10801902145717), received between Oct 18, 2022 and Aug 1, 2023 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (2 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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT AFTER INSERTION AND UPON INITIAL PUMPING, THE "IAB WOULD NOT FULLY UNWRAP AND THE PUMP ALARMED FOR 'A GAS ALARM'". AS A RESULT, THE IAB WAS REMOVED AND A 2ND IAB WAS INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17434922 ↗
• MalfunctionJul 27, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT A 40CC IAB WAS PLACED IN A PATIENT AND RECEIVED HELIUM ALARMS THAT CAUSED THE IABP TO STOP PUMPING. THEY SWITCHED THE HELIUM LINE, THE PUMP ITSELF, AND THE HELIUM CANISTER WITHOUT IMPROVEMENT IN ALARMS. THEY OPTED TO DISCONTINUE THE IABP AS THE PATIENT WAS STABLE WITHOUT IT. THE CATHETER WAS REMOVED AND NOT REPLACED. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17409021 ↗
• MalfunctionJul 25, 2023Gas/Air Leak; Gas/Air Leak

  REPORTED AS "FREQUENT HELIUM LOSS 2 ALARMS IMMEDIATELY AFTER INSERTION". AS A RESULT, THE IAB WAS REMOVED AND A 2ND IAB WAS INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED "STABLE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17390906 ↗
• InjuryJun 30, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHILE IN USE THE IABP HAD "FREQUENT POSSIBLE HELIUM LOSS 3 ALARMS". THE IAB WAS NOTED TO HAVE A SEVERE KINK IT IN. AS A RESULT, A 2ND IAB WAS INSERTED IN THE OPPOSITE FEMORAL ARTERY. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: Needle Stick/Puncture

  MAUDE report 17240594 ↗
• MalfunctionJun 28, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE FOS SENSOR TIP WAS RECESSED. THE FACILITY DID NOT HAVE AP CABLES THAT WERE COMPATIBLE IN ORDER TO MONITOR THE AP VIA THE CENTRAL LUMEN. THE PUMP WAS SOLELY RUNNING OFF OF ECG. AS A RESULT, THE IAB WAS REMOVED AND A 2ND IAB WAS INSERTED AT THE SAME INSERTION SITE. THE NEW IAB FOS WAS CONNECTED AND ZEROED WITHOUT ISSUE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17215873 ↗
• MalfunctionJun 12, 2023Inflation Problem; Inflation Problem

  REPORTED AS "IAB FAILED TO FULLY UNWRAP". IT WAS REPORTED THAT AFTER A SUCCESSFUL INSERTION OF THE CATHETER, THE BALLOON FAILED TO FULLY UNWRAP. AS A RESULT, THE CATHETER WAS REMOVED AND A 2ND CATHETER WAS INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17106226 ↗
• MalfunctionOct 18, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE STAFF CALLED FOR HELP WITH A DAMPENED AP WAVEFORM. THE WAVEFORM IS VERY NARROW, AND ALL OF THE PRESSURES ARE READING WITHIN 10MM OF EACH OTHER. STAFF SAID THEY HAVE DRAWN BLOOD BACK FROM THE CENTRAL LUMEN WITH GOOD RETURN, AND THE LUMEN FLUSHED EASILY. THE STAFF THEN SAID THAT THIS IS A FIBEROPTIC IAB, BUT THE FOS WAS NOT WORKING. UPON CHECKING IT WAS NOTED THAT THE FOS SENSOR WAS RECESSED. THERE IS A VERY SHORT DURATION OF INFLATION WITH THE PATIENT HR AROUND 105. THE AP WAVEFORM IS VERY NARROW, BUT THERE IS A SMALL "BUMP" FROM WHAT APPEARS TO BE SYSTOLE. THERE APPEARS TO BE NO AUGMENTATION FROM THE BALLOON. STAFF SWITCH THE MODE OF OPERATION TO "OPERATOR". TIMING WAS ADJUSTED USING THE HIGHLIGHT ON THE EKG AND SAFE TIMING SETTINGS. THIS WIDENED THE DURATION OF INFLATION ON THE BPW. THE BPW NOW HAS A TOTALLY SQUARED-OFF PLATEAU AND OBVIOUS WIDENING TO THE DEFLATION ARTIFACT AS WELL. THE PUMP ALSO NOW STARTED TO ALARM FOR "HIGH PRESSURE"". ADDITIONAL INFORMATION STATES THAT "A SEVERE KINK WAS INDICATED BY THE BPW MORPHOLOGY. THEY DISCUSSED PLACING A PILLOW UNDER THE HIP AND TRACTION ON THE CATHETER AS POSITIONING TECHNIQUES. WHEN THESE STEPS WERE TAKEN, TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15627126 ↗