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Mirage
Micro Therapeutics, Inc. · Model 103-0608 · UDI-DI 00763000294120
2
510(k) clearances
657
Adverse events (15 deaths)
2
Recalls
33
Facilities
Description
GUIDEWIRE 103-0608 V08 MIRAGE
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-04-18 | Stryker Neurovascular | Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire |
| 2017-08-07 | Microvention, Inc. | There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire. |
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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.