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Tigertriever Revascularization Device TRPP7155Recalls & reported problems

Rapid Medical Ltd · The Tigertriever device is a stentriever that is comprised of an adjustable nitinol braided mesh, stainless steel shaft, nitinol core wire and a handle. The shaft connects the mesh and the handle by the core wire that runs inside the shaft from the distal end of the mesh to the slider activation element in the handle. The mesh is expanded when the physician pulls the slider, since the wires of the mesh are completely radiopaque, the physician sees the mesh under fluoroscopy and controls it until it conforms to the vessel diameter. The design of the wire mesh is optimized to penetrate the clot and encapsulate it during retrieval. Two versions of the device are available. The standard version Tigertriever (TRPP7155) has a net length of 32mm (unexpanded form) and it is delivered through a microcatheter with an internal diameter of 0.021 inches. The shorter version Tigertriever 17 (TRPP7166) has a net length of 23 mm (unexpanded form) and it is delivered through a microcatheter with an internal diameter of 0.017 inches. The Tigertriever is provided with a 3.5 Fr peelable loading sheath. · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07290015107266), received between May 1, 2023 and May 26, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Mechanical Problem2
  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

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

  • InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT WAS DIAGNOSED WITH SEVERE CALCIFIED LESION IN THE LEFT CAROTID AND THE PHYSICIAN WAS UNABLE TO PASS THE LESION WITH HIS SHEATH TO TREAT A MORE DISTAL STROKE. ASPIRATION WITH A ZOOM CATHETER WAS TRIED FIRST. WHEN ASPIRATION FAILED, THE DECISION WAS MADE TO CROSS THE LESION WITH A VELOCITY MICROCATHETER AND TIGERTRIEVER 21. TIGER WAS SUCCESSFULLY EXPANDED. WHEN IT WAS TIME TO PULL THE DEVICE OUT, THE PHYSICIAN EXPERIENCED RESISTANCE AND FULLY COLLAPSED THE DEVICE. THERE WAS STILL RESISTANCE IN THE SYSTEM AND THE DEVICE BROKE OFF AT THE PROXIMAL CONNECTION BETWEEN THE HYPOTUBE SHAFT AND THE MESH. THE PHYSICIAN WAS ABLE TO ASPIRATE THE STENT INTO THE SHEATH USING A 60CC SYRINGE AND NO HARM WAS DONE TO THE PATIENT AND NO PART OF THE STENT WAS LEFT IN THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17009819 ↗
  • InjuryMay 2, 2023Mechanical Problem; Mechanical Problem

    PATIENT WAS DIAGNOSED WITH SEVERE CALCIFIED LESION IN THE LEFT CAROTID AND THE PHYSICIAN WAS UNABLE TO PASS THE LESION WITH HIS SHEATH TO TREAT A MORE DISTAL STROKE. ASPIRATION WITH A ZOOM CATHETER WAS TRIED FIRST. WHEN ASPIRATION FAILED, THE DECISION WAS MADE TO CROSS THE LESION WITH A VELOCITY MICROCATHETER AND TIGERTRIEVER 21. TIGER WAS SUCCESSFULLY EXPANDED. WHEN IT WAS TIME TO PULL THE DEVICE OUT, THE PHYSICIAN EXPERIENCED RESISTANCE AND FULLY COLLAPSED THE DEVICE. THERE WAS STILL RESISTANCE IN THE SYSTEM AND THE DEVICE BROKE OFF AT THE PROXIMAL CONNECTION BETWEEN THE HYPOTUBE SHAFT AND THE MESH. THE PHYSICIAN WAS ABLE TO ASPIRATE THE STENT INTO THE SHEATH USING A 60CC SYRINGE AND NO HARM WAS DONE TO THE PATIENT AND NO PART OF THE STENT WAS LEFT IN THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16852649 ↗
  • MalfunctionMay 1, 2023Mechanical Problem; Mechanical Problem

    PATIENT WAS DIAGNOSED WITH SEVERE CALCIFIED LESION IN THE LEFT CAROTID AND THE PHYSICIAN WAS UNABLE TO PASS THE LESION WITH HIS SHEATH TO TREAT A MORE DISTAL STROKE. ASPIRATION WITH A ZOOM CATHETER WAS TRIED FIRST. WHEN ASPIRATION FAILED, THE DECISION WAS MADE TO CROSS THE LESION WITH A VELOCITY MICROCATHETER AND TIGERTRIEVER 21. TIGER WAS SUCCESSFULLY EXPANDED. WHEN IT WAS TIME TO PULL THE DEVICE OUT, THE PHYSICIAN EXPERIENCED RESISTANCE AND FULLY COLLAPSED THE DEVICE. THERE WAS STILL RESISTANCE IN THE SYSTEM AND THE DEVICE BROKE OFF AT THE PROXIMAL CONNECTION BETWEEN THE HYPOTUBE SHAFT AND THE MESH. THE PHYSICIAN WAS ABLE TO ASPIRATE THE STENT INTO THE SHEATH USING A 60CC SYRINGE AND NO HARM WAS DONE TO THE PATIENT AND NO PART OF THE STENT WAS LEFT IN THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16843653 ↗

Other Catheter, Thrombus Retriever devices

All Catheter, Thrombus Retriever devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.