Surefire Precision Infusion System SPS-21120-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00857136004088), received between Jul 19, 2016 and Jun 15, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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.

• InjuryJun 15, 2017Device Operates Differently Than Expected

  THE PHYSICIAN WAS PLANNING TO USE A SUREFIRE PRECISION INFUSION SYSTEM TO PERFORM A LOWER LOBE KIDNEY EMBOLIZATION THROUGH THE RENAL ARTERY. THE PHYSICIAN TRACKED OUT TO THE DESIRED LOCATION WITH A BOSTON SCIENTIFIC RENEGADE STC MICROCATHETER AND FATHOM 016 GUIDE WIRE. THE RENEGADE MICROCATHETER WAS REMOVED AND EXCHANGED FOR THE SUREFIRE PRECISION INFUSION SYSTEM WHICH WAS TRACKED OVER THE GUIDEWIRE. WHEN THE SUREFIRE PRECISION INFUSION SYSTEM EXITED THE GUIDE CATHETER, ARTERIAL VASOSPASM WAS ENCOUNTERED. THE PHYSICIAN ATTEMPTED TO ADVANCE THE SUREFIRE PRECISION INFUSION SYSTEM THROUGH THE AREA OF VASOSPASM. THIS RESULTED IN DISSECTION OF THE VESSEL. PHYSICIAN INTERVENTION WAS REQUIRED TO STOP THE BLEEDING AND REMOVE THROMBOSIS FROM THE ARTERY. THE PATIENT WAS ADMITTED TO THE HOSPITAL OVERNIGHT FOR MONITORING AND RELEASED THE FOLLOWING DAY.

  Patient problems: Vascular Dissection

  MAUDE report 6645256 ↗
• InjuryJul 19, 2016Improper or Incorrect Procedure or Method

  THE PHYSICIAN WAS USING THE SUREFIRE PRECISION INFUSION SYSTEM TO DELIVER Y90 RADIOEMBOLIZATION SPHERES TO A TUMOR IN THE LIVER. PRIOR TO INFUSION OF THE RADIOEMBOLIZATION SPHERES, THE PHYSICIAN COILED THE RIGHT GASTRIC ARTERY TO PREVENT FLOW OF EMBOLICS TO THE STOMACH. THE SUREFIRE PRECISION WAS PLACED DISTAL TO THE COILED VESSEL. DURING INFUSION NO SLOW FLOW OR REFLUX OF THE RADIOEMBOLIZATION SPHERES WAS OBSERVED. FOLLOWING THE RADIOEMBOLIZATION PROCEDURE A PET CT IMAGE SHOWED RADIATION ACTIVITY IN THE ANTRUM OF THE STOMACH. PATIENT WAS ADMITTED TO THE HOSPITAL AND DISCHARGED AFTER 5 DAYS. ENDOSCOPY SHOWED 2 SMALL ULCERS IN THE STOMACH. NO OTHER MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. BASED UPON DISCUSSION WITH THE PHYSICIAN, USER ERROR IN DEVICE POSITIONING AND APPROPRIATE DEVICE SELECTION FOR THE VESSEL SIZE MAY HAVE CONTRIBUTED TO THE EVENT. BASED UPON NO OBSERVATION OF SLOW FLOW OR REFLUX DURING THE PROCEDURE, THE EVENT IS POTENTIALLY DUE TO A SECONDARY UNIDENTIFIED VESSEL LEADING TO STOMACH, BUT NO IMAGES OF THE PROCEDURE WERE PROVIDED TO CONFIRM.

  Patient problems: Ulcer

  MAUDE report 5807624 ↗