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Catheter, Percutaneous
FDA product code DQY · Class 2 · Cardiovascular
20,377
Registered devices
42,074
Adverse events
620
Recalls
896
510(k) clearances
Devices with this code
Z2 — MEDTRONIC, INC.Cook — COOK INCORPORATEDLauncher™ — MEDTRONIC, INC.Dorado® — Bard Peripheral Vascular, Inc.Launcher — MEDTRONIC, INC.ZUMA® — MEDTRONIC, INC.Mach1™ — BOSTON SCIENTIFIC CORPORATIONPacific™ Plus — MEDTRONIC, INC.CLEARWAY — Atrium Medical CorporationRival® — Bard Peripheral Vascular, Inc.Ballast 088 Long Sheath — BALT USA LLCLauncher — MEDTRONIC, INC.Armada — ABBOTT VASCULAR INC.Launcher — MEDTRONIC, INC.Launcher — MEDTRONIC, INC.Z-MED X™ — B BRAUN INTERVENTIONAL SYSTEMS, INCLauncher — MEDTRONIC, INC.Launcher — MEDTRONIC, INC.POWERFLEX — Cordis US Corp.Convey — PendraCare International B.V.ZUMA® — MEDTRONIC, INC.Z2 — MEDTRONIC, INC.TorFlex Transseptal Guiding Sheath — Baylis Médicale Cie IncBio-Medicus™ — MEDTRONIC, INC.
Recent 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 iss |
| 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. Acco |
| 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. Acco |
| 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. Acco |
| 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. Acco |
| 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. Acco |
| 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. Acco |
| 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. Acco |
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