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Zebra

Q'APEL MEDICAL LLC · Model AC6074-115-20 · UDI-DI 00857545008202

DQY Prescription

510(k) clearances

41,793

Adverse events (906 deaths)

620

Recalls

276

Facilities

Description

The Neurovascular Access System Family consists of sterile, single-use catheters and accessories that are used together to facilitate the insertion and guidance of an appropriately sized interventional device into a selected vessel in the peripheral and neurovasculature. The Neurovascular Access System is comprised of the Neurovascular Access Catheter, Access Tool, Peel Away Introducer and Dilator. The Neurovascular Access System Family is offered in various lengths to accommodate physician preferences and anatomical variations. The distal end of the catheter is coated with hydrophilic coating to reduce friction during use and a radiopaque marker on the distal tip that is visible under fluoroscopy.

Recalls

Date	Firm	Reason
2026-04-30	MICROVENTION INC.	Due to an increase rate of balloon pinhole defects.
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
2025-09-25	BALT USA, LLC	Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
2025-07-29	Boston Scientific Corporation	Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published l
2025-07-29	Boston Scientific Corporation	Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published l
2025-07-29	Boston Scientific Corporation	Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published l
2025-07-29	Boston Scientific Corporation	Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published l
2025-07-29	Boston Scientific Corporation	Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published l
2025-07-29	Boston Scientific Corporation	Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published l
2025-07-29	Boston Scientific Corporation	Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published l

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Data 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.