ARROW IPN039784Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10801902145663), received between Dec 18, 2025 and May 5, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Inflation Problem

  IT WAS REPORTED THAT "AFTER INSERTION, THE WAVE-FORM SIGNAL WAS INCORRECT. UPON CHECKING THE IMAGING, IT WAS FOUND THAT THE BALLOON DID NOT FULLY INFLATE (FULLY OPEN). LATER, EVEN WITH MANUAL HANDLING, IT STILL COULD NOT BE OPENED". 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 25086193 ↗
• MalfunctionJan 29, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT "DURING PROCEDURE, WHEN TIRED INFLATED THE BALLOON IT RUPTURED LEAD TO NOT BEING ABLE TO USE IN THE PROCEDURE". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED AND NOT REPLACED. NO PATIENT INJURY OR COSNEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209937 ↗
• MalfunctionJan 16, 2026Inflation Problem

  REPORTED AS "DELAYED UNWRAPPING AND SIDE PORT DIFFICULTY". THE REPORT FURTHER STATES THAT THERE WAS SHEATH DIFFICULTY NOTED UPON PREP. THE ISSUE WAS RESOLVED BY USING ANOTHER SHEATH IN THE KIT AND THE IAB EVENTUALLY UNWRAPPED. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24097143 ↗
• MalfunctionJan 14, 2026Leak/Splash

  IT WAS REPORTED "AFTER THE CATHETER INSERTED INTO THE PATIENT, THE PUMP ALARMED HELIUM LEAKAGE. CHANGE THE NEW CATHETER". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24068240 ↗
• MalfunctionJan 14, 2026Device Alarm System

  IT WAS REPORTED "AFTER THE CATHETER INSERTED INTO THE PATIENT, THE PUMP ALARMED HELIUM LEAKAGE. CHANGE THE NEW CATHETER". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24067560 ↗
• MalfunctionJan 14, 2026Device Alarm System

  IT WAS REPORTED ", AFTER THE CATHETER INSERTED INTO THE PATIENT, THE PUMP ALARMED HELIUM LEAKAGE. CHANGE THE NEW CATHETER". 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24067270 ↗
• MalfunctionJan 9, 2026Inflation Problem

  IT WAS REPORTED " AFTER THE CATHETER INSERTED INTO THE PATIENT, THE BALLOON COULD NOT INFLATE COMPLETELY. AN EMERGENCY METHOD WAS ATTEMPTED: INFLATING THE BALLOON WITH A SYRINGE. HOWEVER, THERE WAS SIGNIFICANT RESISTANCE, AND DSA IMAGING SHOWED THAT THE BALLOON STILL COULD NOT BE INFLATE. SUBSEQUENTLY, THE CATHETER WAS REPLACED WITH NEW ONE". NO PATIENT INJURY OR COSNEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24020382 ↗
• MalfunctionJan 8, 2026Break

  IT WAS REPORTED "DISTAL TIP OF IAB FAILED TO UNWRAP". 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 "UNKNOWN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24005310 ↗
• MalfunctionJan 7, 2026Material Twisted/Bent

  IT WAS REPORTED "DURING THE CATHETER INSERTION PROCEDURE, THE GUIDEWIRE WAS TOO SOFT AND KINKED. AFTER SPENDING A TOTAL OF ONE HOUR, THE CATHETER WAS SUCCESSFULLY IMPLANTED". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23991848 ↗
• MalfunctionJan 6, 2026Leak/Splash

  IT WAS REPORTED "AFTER THE CATHETER INSERTED INTO THE PATIENT, THE BALLOON WAS FOUND LEAKAGE. CHANGE THE NEW CATHETER". NO PATIENT INJURY OR CONSEQUENE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23974200 ↗
• MalfunctionJan 2, 2026Break

  IT WAS REPORTED "AFTER THE CATHETER INSERTED INTO THE PATIENT, THE BLOOD WAS FOUND IN THE HELIUM PATHWAY AND BALLOON WAS FOUND RUPTURE AFTER THE CATHETER REMOVAL". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REPLACED. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE">.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23944190 ↗
• MalfunctionDec 18, 2025Break; Break

  IT WAS REPORTED "LUER LOCK BROKE OFF OF PRE-DILATOR". 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 "CRITICAL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838097 ↗

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