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HYBRID Guidewire
BALT USA LLC · Model HYBRID1214D · UDI-DI 00818053022784
1
510(k) clearances
664
Adverse events (15 deaths)
2
Recalls
33
Facilities
Description
HYBRID Guidewire is a coiled wire that is designed to fit inside a percutaneous microcatheter for the purpose of directing the catheter through a blood vessel. It is used in association with catheters to enable insertion and easier navigation into the intracranial vascular branches for diagnositc or therapeutic use. Guidewires constitute an important element that conditions the success of the operation. They can be pushed and torqued to move forward through patient's tortuous anatomy.
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.