Pounce ™ Thrombectomy PTS-0607-7F135Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00812339030784), received between May 16, 2024 and Oct 31, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Difficult to Remove” (3 reports).

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

• InjuryOct 31, 2025Fracture; Difficult to Remove; Improper or Incorrect Procedure or Method; Fracture; Difficult to Remove; Improper or Incorrect Procedure or Method

  THE POUNCE ARTERIAL MID-PROFILE (MP) DEVICE WAS USED DURING A PERIPHERAL THROMBECTOMY PROCEDURE VIA LEFT FEMORAL ARTERY ACCESS TO TREAT THROMBUS EXTENDING FROM THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) THROUGH THE DISTAL SFA INTO THE POPLITEAL ARTERY, ESTIMATED AT APPROXIMATELY 50-60 CM IN LENGTH. THE PHYSICIAN HAD NOT PREVIOUSLY USED THE POUNCE SYSTEM AND HAD NOT RECEIVED FORMAL IN-SERVICE TRAINING PRIOR TO THIS CASE. DURING THE FIRST THROMBECTOMY PASS, RESISTANCE WAS ENCOUNTERED AND THE FUNNEL CATHETER AND BASKETS BECAME ENTRAPPED WITHIN A 7 FR, 55 CM SHEATH. ATTEMPTS WERE MADE TO WITHDRAW THE DEVICE AND SHEATH EN BLOC; HOWEVER, SEPARATION OF THE FUNNEL CATHETER SHAFT IN THE DEVICE HANDLE OCCURRED. THE ISSUE WAS REPORTED TO THE MANUFACTURER REPRESENTATIVE AFTER THESE EVENTS HAD ALREADY OCCURRED. CLOT OVERBURDEN WAS SUSPECTED AS THE PHYSICIAN TRIED TO REMOVE THE ENTIRE CLOT WITH ONE PASS. NO FURTHER TROUBLESHOOTING MANEUVERS SUCH AS ASPIRATION, REVERSE LOADING, OR CONTROLLED ROTATION WERE ATTEMPTED PRIOR TO ESCALATION. SURGICAL INTERVENTION WAS REQUIRED, INCLUDING A RIGHT FEMORAL ARTERIAL CUTDOWN FOR DEVICE RETRIEVAL. ALL COMPONENTS WERE REMOVED, AND THE PROCEDURE WAS CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23438340 ↗
• InjuryNov 6, 2024Fracture; Off-Label Use; Difficult to Remove; Fracture; Off-Label Use; Difficult to Remove

  THE DEVICE WAS USED IN A THROMBECTOMY PROCEDURE TO REMOVE SUPERFICIAL FEMORAL ARTERY (SFA) THROMBUS. THE DEVICE MADE A SUCCESSFUL INITIAL PASS WITHOUT INCIDENT. DURING THE SECOND PASS, THE FUNNEL WOULD NOT PASS THROUGH THE TIP OF THE 7FR SHEATH. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE FUNNEL THROUGH THE SHEATH. DURING THE FINAL ATTEMPT TO FORCIBLY REMOVE THE DEVICE, THE FUNNEL BECAME DETACHED FROM INNER WHITE CATHETER. A SURGICAL VESSEL CUTDOWN WAS THEN PERFORMED TO SUCCESSFULLY REMOVE THE DETACHED FUNNEL AND THE WHITE INNER CATHETER. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER PATIENT IMPACT. THE REPORTED ISSUE RESULTED IN A PROCEDURE DELAY OF FOUR HOURS.

  Patient problems: Foreign Body In Patient

  MAUDE report 20617189 ↗
• InjuryMay 16, 2024Difficult to Remove; Difficult to Remove

  THE THROMBECTOMY DEVICE WAS USED IN AN ULTRASOUND-GUIDED PERCUTANEOUS RIGHT COMMON FEMORAL ARTERY ACCESS FOR LEFT LOWER EXTREMITY THROMBECTOMY PROCEDURE. THE DEVICE WAS USED IN THE LEFT TIBIOPERONEAL TRUCK AND POPLITEAL ARTERY. THE PATIENT HAD AN OCCLUSION BEGINNING AT THE P2 SEGMENT OF THE POPLITEAL ARTERY. THE REMAINDER OF THE POPLITEAL ARTERY WAS OCCLUDED AS WELL AS THE TIBIOPERONEAL TRUNK AND ALL 3 TIBIAL ARTERIES. THERE WAS RECONSTITUTION ONLY OF THE DISTAL POSTERIOR TIBIAL ARTERY AT THE DISTAL CALF. A 5FR SHEATH WAS PLACED FOLLOWED BY A SIZING CATHETER. UP-AND-OVER ACCESS OF THE LEFT COMMON FEMORAL ARTERY WAS OBTAINED. THE SIZING CATHETER WAS PLACED IN THE LEFT COMMON FEMORAL ARTERY OVER A GUIDEWIRE. A LEFT LOWER EXTREMITY ANGIOGRAM WAS THEN PERFORMED. THE GUIDEWIRE WAS ADVANCED INTO THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY. A 6FR SHEATH THEN USED AND SUBSEQUENTLY UPSIZED TO A 7FR X 65 CM LENGTH SHEATH. THE PATIENT WAS SYSTEMICALLY HEPARINIZED AND ACT MAINTAINED AT 250 OR GREATER THROUGHOUT THE PROCEDURE. USING AN ANGLED GLIDE CATHETER, THE PHYSICIAN ADVANCED TO THE LEVEL OF THE OCCLUSION. THE GUIDEWIRE WAS THEN EXCHANGED FOR AN 0.18 HIGH-TORQUE GUIDEWIRE. THE PHYSICIAN WAS

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Perforation of Vessels

  MAUDE report 19336758 ↗