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Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
FDA product code POL · Class 2 · Neurology
122
Registered devices
96
Adverse events
3
Recalls
18
510(k) clearances
Devices with this code
Solitaire™ X-PACK — Micro Therapeutics, Inc.Solitaire™ X-PACK — Micro Therapeutics, Inc.Solitaire™ X — Micro Therapeutics, Inc.Solitaire 2 — Micro Therapeutics, Inc.Solitaire™ X-PACK — Micro Therapeutics, Inc.Solitaire™ X-PACK — Micro Therapeutics, Inc.Solitaire™ X-PACK — Micro Therapeutics, Inc.Solitaire™ X-PACK — Micro Therapeutics, Inc.Solitaire™ X-PACK — Micro Therapeutics, Inc.Solitaire™ X-PACK — Micro Therapeutics, Inc.Solitaire ™ Platinum — Micro Therapeutics, Inc.Solitaire ™ Platinum — Micro Therapeutics, Inc.Solitaire™ X-PACK — Micro Therapeutics, Inc.Solitaire ™ Platinum — Micro Therapeutics, Inc.Solitaire™ X-PACK — Micro Therapeutics, Inc.Solitaire™ X — Micro Therapeutics, Inc.Solitaire™ — Micro Therapeutics, Inc.Solitaire™ Platinum — Micro Therapeutics, Inc.Solitaire™ X-PACK — Micro Therapeutics, Inc.Solitaire™ — Micro Therapeutics, Inc.Solitaire™ X-PACK — Micro Therapeutics, Inc.Solitaire™ X-PACK — Micro Therapeutics, Inc.pRESET® Delta Thrombectomy Device (6mm x 30mm) — PHENOX LIMITEDSolitaire™ X-PACK — Micro Therapeutics, Inc.
Recent 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 |
| 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 |
| 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 c |
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