NHancer Rx
IMDS Operations B.V. · Model NRX1413518 · UDI-DI 08718481740231
Description
The NHancer™Rx is a dual lumen catheter intended to use in the coronary and/or peripheral vasculature. The NHancer™Rx is a 0.014” Rapid Exchange (Rx) guide wire support catheter. The NHancer™Rx has an over the wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal end. The NHancer™Rx has an effective length of 135 cm and is compatible with 0.014”/0.36mm or smaller guide wires. The NHancer™Rx has two depth markings located at 95 cm and 105 cm from the distal tip. The NHancer™Rx has a radiopaque marker identifying the distal end of the catheter and a second radiopaque marker located 8 mm from the distal tip identifies the distal end of the OTW lumen. To reduce friction in the guide catheter and vasculature, the distal 15 cm of the shaft is fitted with a hydrophilic coating. To reduce friction of the guide wire in the lumen, the entire lumens of the NHancer Rx are coated with MDX (silicone) coating. To ease catheter loading into the hemostasis device and the guiding catheter a removable stylet (9) is placed in the OTW 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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