Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of StrykerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Stryker Neurovascular with 109 device recalls and 36 510(k) clearances. The most recent is a 510(k) clearance dated Oct 9, 2026: Excelsior Reach Microcatheter.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 9, 2026 | Excelsior Reach MicrocatheterK261649 · QJP | 510(k) clearances |
| Jul 1, 2026 | Trevo Trak 21 MicrocatheterK261889 · QJP | 510(k) clearances |
| Jun 24, 2026 | Target Xtra Detachable CoilK261772 · HCG | 510(k) clearances |
| Apr 6, 2026 | INZONE DETACHMENT SYSTEM, REF: M00345100950Class II · Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; | Device recalls |
| Feb 11, 2026 | AXS Lift Intracranial Base CatheterK253032 · QJP | 510(k) clearances |
| Dec 11, 2025 | Target Detachable CoilK252694 · HCG | 510(k) clearances |
| Oct 17, 2025 | InZone IST Detachment System; IZDS Connecting CableK251832 · HCG | 510(k) clearances |
| Mar 21, 2025 | Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped MicrocatheterK242289 · QJP | 510(k) clearances |
| Feb 18, 2025 | AXS Lift Intracranial Base CatheterK243593 · QJP | 510(k) clearances |
| Aug 30, 2024 | The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end anClass II · Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and | Device recalls |
| Apr 23, 2024 | Trevo ProVue, Catalog: 90184Class II · Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes | Device recalls |
| Apr 23, 2024 | Trevo Trak 21 Microcatheter, Catalog: 90338Class II · Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes | Device recalls |
| Apr 23, 2024 | Synchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wire, 300 cm length, Catalog: M00313310 SYNCHRO .010 WIRE SOFT SClass II · Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes | Device recalls |
| Apr 18, 2024 | The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outClass II · Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires tha | Device recalls |
| Apr 18, 2024 | The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. Class II · Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires tha | Device recalls |
| Apr 18, 2024 | The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside diameter of the Synchro 10 guidewire is 0.01Class II · Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires tha | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
