NA 405154Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067041210), received between Feb 8, 2023 and Oct 12, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

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 16, 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.

• InjuryOct 12, 2023Difficult to Insert; Material Too Rigid or Stiff; Difficult to Insert; Material Too Rigid or Stiff

  DURING THE IMPLANT PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE INCLUDED IN THE PACKAGE WAS TOO HARD AND STIFF TO STRAIGHTEN THE J END OF THE GUIDEWIRE RESULTING IN THE GUIDEWIRE BEING DIFFICULT TO INSERT INTO THE CEPHALIC VEIN. AN ADDITIONAL PUNCTURE SITE IN THE SUBCLAVIAN VEIN WAS DONE AS A WAY OF ACCESS WITH THE SAME SHEATH AND GUIDEWIRE WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17920898 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PNEUMOTHORAX OCCURRED DURING THE PROCEDURE WITHOUT CONSEQUENCES. TWENTY FOUR HOURS FOLLOWING THE IMPLANT PROCEDURE, PRIOR TO DISCHARGE THE XRAY IMAGES SHOWED A SMALL PNEUMOTHORAX WITH NO INTERVENTION NEEDED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Pneumothorax

  MAUDE report 16328638 ↗