Sofia 5F-115cm STR DA5115STRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00812636020082), received between Sep 7, 2016 and Nov 9, 2023 — classified as 1 death, 1 injury, 3 malfunctions.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION RECEIVED. THIS REPORT REPRESENTS CORRECTIONS TO A PREVIOUSLY SUBMITTED MDR. FIELDS CORRECTED ARE LISTED IN H11.

  Patient problems: Obstruction/Occlusion

  MAUDE report 18108056 ↗
• MalfunctionJun 27, 2023Break; Unraveled Material; Break; Unraveled Material

  IT WAS REPORTED THAT AFTER THE SOFIA WAS INSERTED USING A GLIDESHEATH AND MICROCATHETER, ONYX WAS INJECTED. IMMEDIATELY AFTER INJECTION, THE PHYSICIAN THEN NOTICED THE DISTAL END OF THE SOFIA APPEARED TO BE UNWINDING. THE ENTIRE SYSTEM WAS REMOVED. AFTER REMOVAL, THE CATHETER¿S INTERNAL COILING WAS HANGING OUT AT THE END. THE PROCEDURE WAS COMPLETED. THERE WAS NO ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17213945 ↗
• MalfunctionJun 16, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT WHEN NEGATIVE PRESSURE WAS APPLIED TO A SOFIA CATHETER, AIR BUBBLES APPEARED NEAR A PINHOLE LEAK NEAT THE HUB. IT WAS NOT USED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14710862 ↗
• MalfunctionMar 27, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE SOFIA CATHETER WAS REMOVED FROM ITS BOX AND A SMALL TEAR WAS OBSERVED IN THE TOP OF THE PLASTIC STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9892279 ↗
• DeathSep 7, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SEVERE STOKE ON (B)(6) 2016. A THROMBECTOMY WAS PERFORMED IN THE INTERVENTIONAL SUITE. MECHANICAL THROMBECTOMY WAS PERFORMED USING THE FOLLOWING DEVICES: 6FR SHUTTLE SHEATH, 5FR 115CM SOFIA CATHETER, SOLITARE STENTREIVER, MARKSMAN .027. THE PATIENT WAS REPORTED TO INCUR A STROKE, MULTIPLE BRAIN INFARCTS, CLOT RESULTING IN DEATH. A FOREIGN BODY MATERIAL, UNIDENTIFIED SUBSTANCE ALSO WAS OBSERVED IN THE PATHOLOGY REPORT ON (B)(6) 2016. THE PATHOLOGIST IS FURTHER INVESTIGATING THE FOREIGN BODY MATERIAL SUBSTANCE. NO SPECIFIC DEVICE MALFUNCTION WAS REPORTED. THIS INCIDENT IS BEING REPORTED AS A DEATH OCCURRED. TWO SOFIA DEVICES WERE REPORTED, HOWEVER ONE DEVICE WAS OPENED AND WAS ACCIDENTALLY DROPPED ON THE FLOOR. THE REPORTER COULD NOT DETERMINE WHAT DEVICE WAS USED OR WHICH ONE WAS DROPPED ON THE FLOOR. THE SECOND DEVICE LOT REPORTED IS: 151223JC4 (MVI REF.: P16-3246).

  Patient problems: Death

  MAUDE report 5934725 ↗