ARROW IPN039780Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801902145656), received between Jun 19, 2023 and Apr 28, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K981660); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Device Alarm System

  REPORTED AS "UPON IABP STARTUP, IMMEDIATE HIGH PRESSURE AND HELIUM LOSS 3 ALARMS, LARGE HELIUM LEAK ALARM". THE REPORT FURTHER STATES, "IABP CONSOLE REPLACED PRIOR TO CALL, ALARMS UNRESOLVED WITH TROUBLESHOOTING. NO BLOOD IN DRIVELINE. CONNECTED VIA FT OFFERED TO ATTEMPT LEAK TEST, PROVIDER OPTED TO SKIP IT AND JUST EXCHANGE CATHETER, MD ADVISED TO PULL BALLOON AND SHEATH PER IFU. MD PULLED BALLOON THROUGH SHEATH ANYWAYS AND ADVISED THAT IS AGAINST IFU. FOS 40CC CATHETER PLACE, VOLUME ADJUSTED TO 35CC, PATIENT IS TACHYCARDIC AND STEEP ANGLE OF INSERTION PRESENT. IT WAS DISCUSSED HOW THIS CAN CAUSE HIGH PRESSURE ALARMS AND SPOKE ABOUT WHAT TO DO IF ALARMS CONTINUE. RN VERBALIZED UNDERSTANDING". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020600 ↗
• MalfunctionApr 27, 2026Difficult to Advance

  IT WAS REPORTED THAT, "DURING THE CATHETER INSERTION, THE BALLOON FAILED TO PASS SMOOTHLY INTO THE PATIENT'S BODY OVER THE GUIDEWIRE. CHANGE THE NEW CATHETER". THE NEW 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 25006201 ↗
• InjuryJul 17, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT "THE PATIENT WAS PRESCRIBED AN INTRA-AORTIC BALLOON COUNTERPULSATION DUE TO THEIR MEDICAL CONDITION UPON ADMISSION. THE INTENSIVIST PERFORMED THE INSERTION OF THE LEFT FEMORAL INTRODUCER AND ADVANCED THE GUIDE THROUGH IT. SUBSEQUENTLY, AN ATTEMPT WAS MADE TO PASS A 40 CC BALLOON THROUGH THE GUIDE. HOWEVER, UPON ENTERING THE INTRODUCER, AT A TWO-CENTIMETER DISTANCE, RESISTANCE WAS ENCOUNTERED, RAISING SUSPICION OF A POSSIBLE DEVICE FRACTURE. THE PROCEDURE IS ABORTED, AND THE INTRODUCER WITH THE BALLOON IS REMOVED. COMPRESSION IS APPLIED TO THE LEFT FEMORAL ARTERY. MANUAL COMPRESSION WAS PERFORMED TO CONTROL THE HEMATOMA, AND AFTERWARDS, PRESSURE WAS APPLIED USING THE FEMOSTOP DEVICE DUE TO THE PRESENCE OF HEMATOMA RESULTING FROM THE DILATION OF THE ARTERY AND THE INSERTION OF THE INTRODUCER." THE PATIENT CONDITION WAS REPORTED AS "FINE". THE INDICATION FOR USE IS REPORTED AS "SUPPORTIVE THERAPY FOR THE PRESENCE OF CARDIOGENIC SHOCK AND HIGH-DOSE USE OF VASOPRESSORS". ADDITIONAL INFORMATION RECEIVED STATED THAT THE PATIENT EXPIRED THE SAME DAY AS THE IAB INSERTION ATTEMPT/REMOVAL. THE PATIENT WAS IN CRITICAL CONDITION BEFORE THE BALLOON INSERTION, THE UNDERLYING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17334763 ↗
• MalfunctionJun 19, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "AFTER INSERTING AN IABP BALLOON CATHETER ON THE LEFT SIDE, AIR LEAKAGE WAS FOUND, AND THE CATHETER WAS IMMEDIATELY WITHDRAWN AND REPLACED WITH A NEW ONE". THE 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 17151675 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K981660. One submission often covers many models, so check the product and lot details in each record.

• Z-1061-2016 · Feb 10, 2016 · Terminated
  RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diasto
• Z-1063-2016 · Feb 10, 2016 · Terminated
  Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during dia