Triever16 Curve 25-201Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850291007437), received between Mar 5, 2024 and Mar 24, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Material Separation

  ON (B)(6) 2026, A PATIENT UNDERWENT PULMONARY EMBOLISM (PE) THROMBECTOMY USING STRYKER PERIPHERAL VASCULAR DEVICES. WHILE REMOVING THE TRIEVER16, A SECTION OF THE CATHETER THAT WAS ALREADY OUTSIDE OF THE PATIENT'S VASCULATURE BROKE IN HALF. THE DISTAL END WAS ABLE TO BE REMOVED FROM THE PATIENT WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678050 ↗
• InjuryMar 5, 2024Use of Device Problem; Use of Device Problem

  A FEMALE PATIENT WITH A BILATERAL PULMONARY EMBOLISM (PE) PRESENTED TO THE EMERGENCY DEPARTMENT AND WAS SCHEDULED FOR A THROMBECTOMY WITH THE INARI FLOWTRIEVER SYSTEM ON (B)(6) 2024. THE CLOT AGE WAS ESTIMATED AT 8 DAYS. THE INITIAL THROMBECTOMY WAS SUCCESSFUL IN REMOVING APPROXIMATELY 80% OF THE CLOT BURDEN, BUT THE PHYSICIAN WANTED TO RETRIEVE A SMALL CLOT REMAINING IN THE TRUNCUS ANTERIOR. THE PHYSICIAN ATTEMPTED TO PASS THE TRIEVER16 CURVE OVER A WHOLEY GUIDEWIRE TO THE RIGHT TRUNCUS ANTERIOR. HOWEVER, THE RIGHT VENTRICLE PERFORATED AND THE PATIENT ARRESTED; A CODE WAS INITIATED. THE PATIENT WAS UNRESPONSIVE FOR 30 MINUTES, HOWEVER, INTERVENTION MEASURES (EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND INTUBATION) WERE ULTIMATELY SUCCESSFUL IN ACHIEVING RETURN OF SPONTANEOUS CIRCULATION (ROSC) AND THE PATIENT'S VITALS WERE STABLE. PERICARDIOCENTESIS WAS PERFORMED WITH A LARGE VOLUME (300 CC) OF BLOOD REMOVED AND RETURNED VIA THE INARI FLOWSAVER AND THE INARI INTRI24 SHEATH. THE PATIENT WAS TRANSFERRED TO THE ICU IN STABLE CONDITION AND WILL BE EVALUATED FOR ANY FURTHER INTERVENTION.

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Cardiogenic Shock

  MAUDE report 18834250 ↗