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ARROW
TELEFLEX INCORPORATED · Model IPN035977 · UDI-DI 30801902129247
10
510(k) clearances
7,853
Adverse events (77 deaths)
23
Recalls
97
Facilities
Description
VPS G4(TM) Base Unit and Interface with Accessories-Refurbished
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 issues and limited repo |
| 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 catheter, which may require |
| 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 brightness. |
| 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 micron) of damaged o- |
| 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 flake off when the de |
| 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-port of the catheter. |
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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.