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pRESET® Thrombectomy Device (4mm x 20mm)

PHENOX LIMITED · Model PRE-4-20 · UDI-DI 05391530910002

NRY POL Prescription

510(k) clearances

8,663

Adverse events (901 deaths)

Recalls

Facilities

Description

The pRESET Thrombectomy Device is designed to restore blood flow in the neurovasculature by mechanical removal of thrombus in patients experiencing acute ischemic stroke due to large vessel occlusion with thrombus. The device is designed for use in large vessels of the neurovasculature such as the internal carotid artery (ICA) and middle cerebral artery (MCA).

Recalls

Date	Firm	Reason
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
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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.