Tigertriever 17 Revascularization Device
RAPID MEDICAL LTD · Model TRPP7166 · UDI-DI 07290015107273
Description
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.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-24 | Penumbra Inc. | Due to manufacturing issues reperfusion catheters may fracture. |
| 2026-06-03 | Penumbra, Inc. | Due to manufacturing issues, reperfusion catheters may fractures |
| 2025-02-26 | Qapel Medical Inc. | Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur. |
| 2025-01-02 | Scientia Vascular, Inc. | Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier. |
| 2024-08-05 | MICROVENTION INC. | Due to Retrieval Device product labels stating the incorrect expiration dates that (5 years instead of 3 years) which extends beyond their true expiration date. |
| 2024-04-23 | Stryker Neurovascular | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so t |
| 2024-03-08 | ROUTE 92 MEDICAL INC | Their is the potential for distal tip separation at the proximal marker band of the delivery catheters |
| 2021-08-13 | IMPERATIVE CARE INC | There is a potential for distal end of catheters to fracture and become detached. |
| 2020-12-15 | Penumbra Inc. | The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel dama |
| 2020-12-15 | Penumbra Inc. | The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel dama |
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