Protrieve Sheath 60-101Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850291007222), received between Sep 15, 2022 and Aug 13, 2025 — classified as 1 death, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2025Material Separation; Material Separation

  ON JULY 15, 2025, INARI MEDICAL RECEIVED A COPY OF A VOLUNTARY MEDWATCH MW5172147 THAT STATED A PROTRIEVE SHEATH TORE APART ON INSERTION INTO THE INSERTION PORT AND IT DID NOT ENTER THE PATIENT. THE DEVICE WAS NO LONGER USED DURING THE PROCEDURE. PER MEDWATCH EVENT/PROBLEM SECTION "INARI SHEATH, ON INSERTION, TORE APART, MD DISCONTINUED USE OF THE PRODUCT. THE DEVICE DID NOT ENTER THE PT JUST THE INSERTION PORT ."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22799034 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO RECENTLY UNDERWENT A THROMBECTOMY ON (B)(6) 2024 TO ADDRESS HER PULMONARY EMBOLISM (PE) WAS SCHEDULED FOR A THROMBECTOMY ON (B)(6) 2024 WITH THE INARI CLOTTRIEVER THROMBECTOMY SYSTEM TO ADDRESS A LEFT LOWER EXTREMITY DEEP VEIN THROMBOSIS (DVT) (WHICH WAS NOT ADDRESSED DURING HER PREVIOUS PE THROMBECTOMY). THE PRIOR PE THROMBECTOMY (PERFORMED USING INARI DEVICES) WAS UNEVENTFUL AND THE CASE PLAN WAS TO ADDRESS THE PE FIRST AND SCHEDULE THE DVT THROMBECTOMY AT A LATER DATE. THE CLOT AGE WAS ESTIMATED AT 30 DAYS. THE PATIENT WAS PLACED IN A SUPINE POSITION AND THE INTRAJUGULAR VEIN WAS ACCESSED WITH AN INARI PROTRIEVE. THE INARI CLOTTRIEVER XL CATHETER (CTXL) WAS THEN INTRODUCED, AND 3 PASSES WERE PERFORMED WHICH REMOVED A SUBSTANTIAL AMOUNT OF CLOT. THE PROTRIEVE WAS SECURED PRIOR TO THE PASSES BUT DID RETRACT APPROXIMATELY 2 INCHES DURING THE PROCEDURE. THE PROTRIEVE WAS RE-POSITIONED AND ONE MORE PASS WAS PERFORMED WITH THE CTXL. A VENOGRAM WAS PERFORMED WHICH REVEALED THAT FULL PATENCY WAS RESTORED. THE PROCEDURE WAS CONCLUDED, AND THE ACCESS SITE WAS CLOSED. UNFORTUNATELY, THE PATIENT BEGAN TO DECOMPENSATE AND IMAGING REVEALED CLOT IN THE RIGHT PULMONARY ARTE

  Patient problems: Cardiovascular Dysfunction/Insufficiency; Hypoxia; Pulmonary Embolism; Tachycardia

  MAUDE report 18858388 ↗
• DeathSep 15, 2022Use of Device Problem; Use of Device Problem

  A FEMALE PATIENT IN HER EARLY 60'S PRESENTED TO THE HOSPITAL WITH LEG EDEMA AND PAIN. THE PATIENT WAS DIAGNOSED WITH BILATERAL DEEP VEIN THROMBOSIS (DVT) AND SCHEDULED FOR A THROMBECTOMY WITH THE INARI CLOTTRIEVER THROMBECTOMY SYSTEM ON (B)(6) 2022. THE PATIENT'S MEDICAL HISTORY INCLUDED BREAST CANCER IN 2011; TREATMENT CONSISTED OF A MASTECTOMY AND CHEMOTHERAPY. THE PATIENT WAS POSITIONED SUPINE IN BILATERAL FROG-LEG POSITION AND ACCESS WAS GAINED THROUGH THE INTERNAL JUGULAR (IJ) VEIN. ACCESS WAS THEN GAINED TO THE POPLITEAL VEIN AND THE PHYSICIAN DILATED UP TO THE 13 FR CLOTTRIEVER SHEATH. THE INARI PROTRIEVE SHEATH WAS THEN INSERTED INTO THE IJ OVER A 145 CM AMPLATZ SUPERSTIFF GUIDEWIRE WITH J-TIP. THE PATIENT HAD A SMALL THROMBUS AT THE TOP OF THE INFERIOR VENA CAVA (IVC) AT THE ATRIAL JUNCTION. THE PHYSICIAN WANTED TO ATTEMPT A VACUUM ASPIRATION IN THE RIGHT ATRIUM (RA) THROUGH THE PROTRIEVE SHEATH PRIOR TO DEPLOYING THE FUNNEL. WHEN THE PHYSICIAN REMOVED THE DILATOR FROM THE PROTRIEVE SHEATH, THE AMPLATZ SS GUIDEWIRE WAS INADVERTENTLY REMOVED WITH ALONG WITH IT. THE PHYSICIAN RECOGNIZED IMMEDIATELY THAT THE GUIDEWIRE WAS REMOVED AND WANTED TO RELEASE SUCTION TO PREVENT ASPIR

  Patient problems: Air Embolism; Cardiac Arrest

  MAUDE report 15433183 ↗