Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1301-2022 — Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797

U.S. FDA — Device Enforcement · United States · 2022-05-13 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1301-2022
Date of alert
2022-05-13
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Volcano Corp
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
300004856772
Reported risk: Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.