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HiWire
COOK INCORPORATED · Model G36324 · UDI-DI 00827002363243
DQX
Prescription
10
510(k) clearances
33,688
Adverse events (927 deaths)
258
Recalls
256
Facilities
Description
HiWire Hydrophilic Wire Guide
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LP | The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.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. |
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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.