Home › Device types › OBJ
Catheter, Ultrasound, Intravascular
FDA product code OBJ · Class 2 · Cardiovascular
226
Registered devices
8,056
Adverse events
23
Recalls
80
510(k) clearances
Devices with this code
ACIST Kodama® Coronary Imaging Catheter — ACIST MEDICAL SYSTEMS, INC.ACIST HDi® System Console — ACIST MEDICAL SYSTEMS, INC.SLT IVUS P1 Cart — Provisio Medical, Inc.OptiCross X — BOSTON SCIENTIFIC CORPORATIONARROW — TELEFLEX INCORPORATEDACUSON Origin ICE Diagnostic Ultrasound System — SIEMENS MEDICAL SOLUTIONS USA, INC.ViewFlex™ — IRVINE BIOMEDICAL, INC.EPIQ 7W Ultrasound System — Philips Ultrasound LLCACUSON P500 ICE Ultrasound System — SIEMENS MEDICAL SOLUTIONS USA, INC.EPIQ 5W Ultrasound System — Philips Ultrasound LLCACUSON Origin Diagnostic Ultrasound System — SIEMENS MEDICAL SOLUTIONS USA, INC.TVC Imaging System™ — Nipro Vascular Innovations Americas, Inc.OptiCross™ 6 HD — BOSTON SCIENTIFIC CORPORATIONNuVision Connector Cable — Biosense Webster IncDisposable Intracardiac Echocardiography Catheter — Jiangsu Tingsn Technology Co., Ltd.Visions PV .018 Digital IVUS Catheter — Philips Image Guided Therapy CorporationARROW — TELEFLEX INCORPORATEDARROW — TELEFLEX INCORPORATEDAffiniti 70 Ultrasound System — Philips Ultrasound LLCEPIQ Elite Ultrasound Circular Edition — Philips Ultrasound LLCAffiniti 30 Ultrasound System — Philips Ultrasound LLCSOUNDSTAR CRYSTAL Ultrasound Catheter — Biosense Webster IncAffiniti CVx Diagnostic Ultrasound System — Philips Ultrasound LLCEPIQ Diagnostic Ultrasound System — Philips Ultrasound LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 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 |
| 2025-06-13 | Volcano Corp | Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without appropriate sheath and/or guide cathete |
| 2025-03-12 | Conavi Medical Inc. | Due to manufacturing issues there is a potential for the catheter sheath to detach. |
| 2024-03-05 | Boston Scientific Corporation | Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image bright |
| 2022-05-13 | Volcano Corp | Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications |
| 2022-05-13 | Volcano Corp | Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications |
| 2021-01-22 | Acist Medical Systems | Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section of the catheter. Further testing indicated that pieces (>200 m |
| 2020-08-24 | Boston Scientific Corporation | Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping length markings near the proximal end of the catheter shaft can f |
| 2020-05-22 | Siemens Medical Solutions USA, Inc. | Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node block. |
| 2018-10-17 | Volcano Corporation | Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the potential inability to pass the guidewire through the y-po |
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