Home › Device types › NRY
Catheter, Thrombus Retriever
FDA product code NRY · Class 2 · Cardiovascular
458
Registered devices
8,617
Adverse events
26
Recalls
113
510(k) clearances
Devices with this code
Solitaire™ X-PACK — Micro Therapeutics, Inc.Penumbra System — PENUMBRA, INC.CEREGLIDE — Cerenovus, Inc.Penumbra System — PENUMBRA, INC.CEREGLIDE — Cerenovus, Inc.Zoom 4S Catheter — IMPERATIVE CARE, INC.Solitaire™ X-PACK — Micro Therapeutics, Inc.CEREGLIDE — Cerenovus, Inc.Esperance 3+ Aspiration Catheter System — Shanghai Wallaby Medical Technologies Co., Inc.Penumbra System — PENUMBRA, INC.Solitaire™ X — Micro Therapeutics, Inc.Zoom 88 Large Distal Platform — IMPERATIVE CARE, INC.Penumbra System — PENUMBRA, INC.EMBOTRAP — NEURAVI LIMITEDSocrates — SCIENTIA VASCULAR LLCZoom 4S Catheter — IMPERATIVE CARE, INC.AXS VECTA 71 — Stryker CorporationSolitaire 2 — Micro Therapeutics, Inc.Penumbra System — PENUMBRA, INC.JET — PENUMBRA, INC.RED 68 — PENUMBRA, INC.ACE — PENUMBRA, INC.APRO 70 Catheter — Alembic, LLCSolitaire™ X-PACK — Micro Therapeutics, Inc.
Recent 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 ster |
| 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 |
| 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 p |
| 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 p |
| 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 p |
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