ARROW IPN915328Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20801902162001), received between Oct 18, 2022 and Dec 14, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2022Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  REPORTED ISSUE: DURING TREATMENT FOR CARDIOGENIC SHOCK, AT ABOUT 17:00 ON NOVEMBER 2 WHEN THE IAB CATHETER IN THE LEFT FEMORAL ARTERY, WAS REMOVED FROM THE PATIENT, IT WAS FOUND THAT THE BALLOON WAS VERY HARD TO PULL BACK INTO THE ARTERIAL SHEATH, AND AFTER PULLING FOR A WHILE, IT COULD NOT BE PULLED, AND THE BALLOON COULD NOT ENTER THE SHEATH. IT WAS PULLED OUT TOGETHER WITH THE SHEATH AND BALLOON WITHOUT RESISTANCE, AND THE PATIENT WAS WELL WITH NO BLOOD LEAKAGE. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15982568 ↗
• MalfunctionOct 18, 2022Material Twisted/Bent; Material Twisted/Bent

  THE REPORT STATES "AFTER THE SHEATH WAS INSERTED, THE CATHETER WAS EVACUATED, AND WHEN IMPLANTED, IT COULD NOT PASS THROUGH THE CENTRAL CAVITY OF THE CATHETER, AND THE CATHETER WAS FOUND KINKED. SUCCESSFUL IMPLANTATION AFTER REPLACEMENT OF A NEW CATHETER." ADDITIONAL INFORMATION STATES THAT A SECONDARY CATHETER WAS INSERTED AT THE SAME INSERTION SITE. NO DELAY IN THERAPY. NO REPORT OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15626901 ↗

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-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
• 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