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Drivewire LR
RAPID MEDICAL LTD · Model DRLR7464 · UDI-DI 07290015107235
1
510(k) clearances
670
Adverse events (15 deaths)
2
Recalls
34
Facilities
Description
The Drivewire Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The Drivewire Guidewire is intended to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries.
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.