IOPS™ ATW-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00843152102037), received between Jun 13, 2023 and Feb 4, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 11, 2025Open, Classified

   Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.

   Z-1760-2025 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2025Peeled/Delaminated; Peeled/Delaminated

  DURING A BEVAR (BRANCHED ENDOVASCULAR AORTIC REPAIR) PROCEDURE, AN IOPS ATW-2 GUIDEWIRE WAS DAMAGED UPON REMOVAL FROM THE PATIENT. DURING REMOVAL, THE PHYSICIAN NOTED SOME RESISTANCE BUT CONTINUED TO RETRACT THE GUIDEWIRE. AFTER THE GUIDEWIRE WAS REMOVED, IT WAS FOUND THAT THE HYDROPHILIC COATING ON THE DISTAL TIP HAD BEGUN TO DELAMINATE. NO PATIENT ADVERSE EFFECTS WERE REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21306703 ↗
• MalfunctionJun 13, 2023Material Frayed; Material Frayed

  DURING A MINIMALLY INVASIVE VASCULAR SURGERY PERFORMED AT VANDERBILT UNIVERSITY MEDICAL CENTER, DR. ADVANCED THE IOPS GUIDEWIRE ATW-2 THROUGH A CATHETER AND SHEATH (BOTH FROM ANOTHER MANUFACTURER) THAT HAD ALREADY CANNULATED THE PMEG FENESTRATION TO ACCESS THE SMA. THE IOPS WIRE WAS SWITCHED OUT FOR ANOTHER WIRE FROM ANOTHER MANUFACTURER. BEFORE INSERTING IT BACK INTO THE SHEATH TO ACCESS THE CELIAC ARTERY, DR. NOTICED THAT THE WIRE COVERING OVER THE SENSOR WAS BECOMING DETACHED AND DECIDED NOT TO PROCEED ANY FURTHER. NO PATIENT ADVERSE EFFECTS WERE REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17119007 ↗
• MalfunctionJun 13, 2023Material Frayed; Difficult to Remove; Material Frayed; Difficult to Remove

  DURING A MINIMALLY INVASIVE VASCULAR SURGERY PERFORMED AT VANDERBILT UNIVERSITY MEDICAL CENTER, THE IOPS GUIDEWIRE ATW-2 WAS USED IN CONJUNCTION WITH A 7FR STEERABLE SHEATH AND A 90 CM CATHETER FROM ANOTHER MANUFACTURER. THE GOAL WAS TO CANNULATE THE CELIAC TRUNK OFF THE AORTA. THE GUIDEWIRE WAS IN THE CATHETER, AND THE CATHETER/GUIDEWIRE WERE IN THE STEERABLE SHEATH. THE SHEATH WAS PLACED INTO POSITION AND STEERED TO ENGAGE THE CELIAC OSTIUM SUCH THAT THE GUIDEWIRE CAN BE ADVANCED TO ATTEMPT TO CANNULATE THE VESSEL. THE DOCTOR FELT RESISTANCE TRYING TO PULL THE GUIDEWIRE BACK INTO THE CATHETER/SHEATH. ONCE REMOVED FROM THE PATIENT, THE HYDROPHILIC COATING ON THE TIP OF THE GUIDEWIRE WAS FOUND TO BE DAMAGE UPON INSPECTION. NO PATIENT ADVERSE EFFECTS WERE REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17119000 ↗