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ReCross

IMDS Operations B.V. · Model RC1414025 · UDI-DI 08718481740309

DQY Prescription

510(k) clearances

41,793

Adverse events (906 deaths)

620

Recalls

276

Facilities

Description

The ReCross is a dual lumen catheter intended to use in the coronary and/or peripheral vasculature. The ReCross is a 0.014” Over The Wire (OTW) guide wire support catheter. The ReCross has two over the wire OTW lumens that runs the length of the catheter. The ReCross has two depth markings located at 95 cm and 105 cm from the distal tip. The ReCross has a radiopaque marker identifying the distal end of the catheter, a second radiopaque marker in the stylet lumen located 8 mm from the distal tip identifies the distal end of the OTW lumen and a third radiopaque marker in the tip lumen located at 12 mm from the distal tip indentifying the side port. To reduce friction in the guide catheter and vasculature, the distal shaft is fitted with a hydrophilic coating. To reduce friction of the guide wire in the lumen, the entire lumens of the ReCross are coated with MDX (silicone) coating. To ease catheter loading into the hemostasis device and the guiding catheter a removable stylet is placed in the stylet lumen

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.