ARROW IPN039779Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10801902145632), received between Oct 11, 2022 and Apr 17, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Device Alarm System

  IT WAS REPORTED "AFTER THE CATHETER INSERTED INTO THE PATIENT, THE PUMP TRIGGERED A HELIUM LEAKAGE ALARM. CHANGE THE CATHETER". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: Insufficient Information

  MAUDE report 24912414 ↗
• MalfunctionApr 16, 2026Material Integrity Problem

  IT WAS REPORTED "THERE WAS A LOSS OF BARRIER FUNCTION WHEN THE CONDOM MET THE INTRODUCER". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED AND REPLACED. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 24896268 ↗
• MalfunctionNov 17, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE PATIENT UNDERWENT CAG, PTCA WITH POSTOPERATIVE IABP SUPPORT, THE SURGEON INSERTED THE BALLOON, WHEN THE BALLOON WAS WITHDRAWN FROM THE BOX THERE WAS A SLIGHT KINKED OF THE BALLOON, [THE SURGEON] TRIED TO INSERT THE BALLOON, THE INSERT PROCESS WAS NOT SMOOTH AND COULD NOT BE INSERTED, THE BALLOON WAS WITHDRAWN AND REPLACED WITH A NEW BALLOON, THE IMPLANTATION WAS SUCCESSFUL". FURTHER INFORMATION STATES THAT THE SECOND CATHETER WAS INSERTED AT THE SAME INSERTION SITE. THE PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15815029 ↗
• MalfunctionOct 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "THE PATIENT WAS ADMITTED TO (B)(6) ON (B)(6) 2022 AND WAS D IAGNOSED WITH 'ACUTE INFERIOR WALL MYOCARDIAL INFARCTION'. AFTER DISCUSSION IN THE DEPARTMENT, 'EMERGENCY CAG + PCI IF NECESSARY' WAS PROPOSED. INTRAOPERATIVELY, THE PATIENT HAD POOR CARDIAC FUNCTION AND WAS TREATED WITH IABP SUPPORT. AFTER THE BALLOON WAS INSERTED, THE PUMP ALARMED, AND THEN BLOOD WAS FOUND IN THE BALLOON, WHICH WAS JUDGED TO BE A BALLOON RUPTURE. THE BALLOON WAS REPLACED WITH A NEW ONE AND WAS INSERTED SUCCESSFULLY, WITH NORMAL COUNTERPULSATION WORKING". THE SECOND CATHETER WAS INSERTED AT THE SAME INSERTION SITE. THE CURRENT PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15683611 ↗
• MalfunctionOct 11, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "PATIENT SUFFERED FROM ACUTE MYOCARDIAL INFARCTION AND WAS SENT TO THE CCU FOR EMERGENCY TREATMENT. AFTER THE OPERATION, THE IAB CATHETER WAS INSERTED FOR ASSISTANCE. BLOOD WAS FOUND, AFTER CHECKING, IT WAS FOUND THAT THE BALLOON WAS RUPTURED. AS A RESULT, THE CATHETER WAS REPLACED AT THE SAME INSERTION SITE AND WORKED AS EXPECTED. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15575223 ↗