Reported Jul 6, 2022 · Ongoing
Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
Volcano Corp.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Volcano Corp · 3721 Valley Centre Dr Ste 500 · San Diego, CA · 92130-3328
Is this the product you have?
- Volcano Visions PV. 035 Digital IVUS Catheter REF 88901
- PN
300005384002 Rx OnlySterile EOCE 2797
- Lot codes and dates
- All Lots containing IFU Part
- Number 300004856772/A Revision Date05/2021
- UDI/DI00845225002329
- Amount recalled
- 14.031 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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