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AGILITY
Cerenovus, Inc. · Model 614-541 · UDI-DI 10886704029083
1
510(k) clearances
34,017
Adverse events (937 deaths)
258
Recalls
257
Facilities
Description
AGILITY 16 STEERABLE GUIDEWIRES Guidewire Dia. .016 Inch (.40mm) Usable Length 175cm 8cm Steerable Guidewire with Hydrophilic Coating Tip Flexibility Standard Contents: 1 guidewire, 1 torquing device and 1 introducer.
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LP | The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.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.