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pRESET® LITE Thrombectomy Device (4mm x 20mm)
PHENOX LIMITED · Model PRE-LT-4-20 · UDI-DI 05391530910101
1
510(k) clearances
96
Adverse events (2 deaths)
3
Recalls
12
Facilities
Description
The pRESET® LITE Thrombectomy Device is designed to restore blood flow in the neurovasculature by mechanical removal of thrombus in patients experiencing ischemic stroke due to acute vessel occlusion with thrombus.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 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 |
| 2024-04-23 | 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 |
| 2020-09-21 | Stryker Neurovascular | Increase in fracture complaints of the flexible, tapered core wire, resulting in stent retriever separation from the core wire during use. The stent retriever can be left behind in |
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Get your free API keyRead the docsData 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.