Home › BALT USA LLC › HYBRID Guidewire
HYBRID Guidewire
BALT USA LLC · Model HYBRID008D · UDI-DI 00818053022753
1
510(k) clearances
33,838
Adverse events (932 deaths)
258
Recalls
256
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 |
|---|---|---|
| 2026-06-26 | Galt Medical Corporation | Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits. |
| 2026-05-08 | Merit Medical Systems, Inc. | Due to unsealed portions of pouches. |
| 2026-04-21 | ARROW INTERNATIONAL, LLC | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited repo |
| 2026-03-05 | Cook Incorporated | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2026-03-05 | Cook Incorporated | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2026-03-05 | Cook Incorporated | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2026-02-25 | Medline Industries, LP | The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. |
| 2025-03-27 | Galt Medical Corporation | Due to a potential open seal in the sterile barrier packaging. |
| 2024-10-14 | Cook Incorporated | Devices from the affected device lots have labels that state the incorrect expiration dates. |
| 2024-10-08 | Cook Incorporated | Affected device lots have labels that state the incorrect expiration dates. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.