SafeSheath™ 00884450281291Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450281291), received between Feb 28, 2020 and Sep 14, 2020 — classified as 1 injury, 1 malfunction.

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

• MalfunctionSep 14, 2020Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PATIENT EXPERIENCED "SLIGHT" PNEUMOTHORAX. THE INTRODUCER SHEATH EXHIBITED A PUNCTURE AND LEAKED AIR. THE SHEATH WAS ATTEMPTED NOT USED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pneumothorax

  MAUDE report 10526833 ↗
• InjuryFeb 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING SEVERAL ATTEMPTS TO ACQUIRE PERCUTANEOUS VASCULAR ACCESS VIA THE PATIENT'S SUBCLAVIAN VEIN, A HEMATOMA AND A PSEUDOANEURYSM FORMED. THE PHYSICIAN WAS UNSUCCESSFUL IN ACQUIRING VENOUS ACCESS WITH THE GUIDEWIRE AND ACCESS NEEDLE. THE HEMATOMA WAS TREATED BY THE MEDICAL STAFF AND A VASCULAR STENT WAS EVENTUALLY PLACED BY THE PHYSICIAN TO SUCCESSFULLY TREAT THE PATIENT'S PSEUDOANEURYSM WITH NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: Pseudoaneurysm

  MAUDE report 9772392 ↗