Surefire Infusion System SHF-38120-LTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00857136004019), received between Jul 7, 2016 and Jul 7, 2016 — classified as 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2016Break; Break

  FOLLOWING A SUCCESSFUL PULMONARY CHEMO-EMBOLIZATION PROCEDURE WITH THE SUREFIRE INFUSION SYSTEM, THE PHYSICIAN HAD DIFFICULTY FULLY RE-SHEATHING THE EXPANDABLE TIP. THE PHYSICIAN PULLED ON THE HYPOTUBE AGAINST RESISTANCE IN AN ATTEMPT TO RETRACT THE EXPANDABLE TIP INTO THE CATHETER. AT THAT TIME, THE EXPANDABLE TIP DETACHED FROM THE CATHETER. THE EXPANDABLE TIP WAS SEEN UNDER FLUOROSCOPY IN THE EMBOLIZED VESSEL. THE PHYSICIAN DETERMINED THAT INTERVENTION WAS NOT NECESSARY TO RETRIEVE THE TIP. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5775243 ↗