SafeSheath® Worley 00884450483749Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450483749), received between Apr 11, 2023 and Apr 11, 2023 — classified as 2 injuries.

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

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.

• InjuryApr 11, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A BIVENTRICULAR PACEMAKER/ IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (BIV-ICD) IMPLANT PROCEDURE, THE VEIN SELECTOR TIP BECAME WEDGED AND DETACHED WITHIN THE PATIENT'S RIGHT ATRIUM. A VASCULAR SNARE DEVICE WAS SUCCESSFULLY USED TO REMOVE THE FOREIGN BODY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE FOR THIS PATIENT. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16717217 ↗
• InjuryApr 11, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A BIVENTRICULAR PACEMAKER/ IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (BIV-ICD) IMPLANT PROCEDURE, THE VEIN SELECTOR TIP DETACHED WITHIN THE PATIENT'S CORONARY SINUS. A VASCULAR SNARE WAS UNSUCCESSFULLY USED IN AN ATTEMPT TO REMOVE THE FOREIGN BODY. THE FOREIGN BODY WAS LEFT WITHIN THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT. THE PATIENT IS STABLE AND ASYMPTOMATIC.

  Patient problems: Foreign Body In Patient

  MAUDE report 16717130 ↗