Home › KANEKA CORPORATION › METACROSS RX
METACROSS RX
KANEKA CORPORATION · Model BD-L80080ER · UDI-DI 04540778153752
DQY
Prescription
1
510(k) clearances
41,518
Adverse events (903 deaths)
620
Recalls
276
Facilities
Description
METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.