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Carrier™ Delivery Catheter

BALT USA LLC · Model CR7071 · UDI-DI 00810068561944

DQYQJP Prescription
1
510(k) clearances
42,074
Adverse events (914 deaths)
620
Recalls
276
Facilities

Description

The Carrier™ Delivery Catheter is a single lumen, variable stiffness, composite catheter. The design facilitates the advancement of the catheter and is intended to assist the delivery of interventional devices in the peripheral and neurovasculature. The outer surface of the Carrier™ Delivery Catheter is coated with a hydrophilic coating to increase lubricity. The proximal end of the Carrier™ Delivery Catheter incorporates a luer fitting for the attachment of accessories. Two radiopaque markers at the distal end help to facilitate fluoroscopic visualization. A Steam Shaping Mandrel and Peel-away Introducer Tube are included within the tray. The Carrier™ Delivery Catheter is provided sterile, non-pyrogenic, and is intended for single use only.

Recalls

DateFirmReason
2026-04-30MICROVENTION INC.Due to an increase rate of balloon pinhole defects.
2026-04-21ARROW INTERNATIONAL, LLCLidocaine, 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
2025-09-25BALT USA, LLCDue to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
2025-07-29Boston Scientific CorporationBoston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published l
2025-07-29Boston Scientific CorporationBoston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published l
2025-07-29Boston Scientific CorporationBoston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published l
2025-07-29Boston Scientific CorporationBoston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published l
2025-07-29Boston Scientific CorporationBoston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published l
2025-07-29Boston Scientific CorporationBoston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published l
2025-07-29Boston Scientific CorporationBoston 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.