Reported Jan 23, 2019 · Terminated
Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0200.272 Product Usage: The Volcano PV .035…
Volcano Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 Corporation · 2870 Kilgore Rd · Rancho Cordova, CA · 95670-6133
Is this the product you have?
- Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0200.272
- Product UsageThe Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultrasound transducer on the distal tip. The transducer utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels. The devices are provided sterile and are single use disposable devices
- Lot codes and dates
- Batch Numbers
0301425755030141894303014244260301420226030142575603014257580301424427030141894203014257570301430789030143079003014307920301430791030142022703014316560301431657030143165803014385920301440863030143859303014414050301441406030144265803014462070301450813030145081403014535310301457395030145739603014573970301457398030146589403014620010301462002030146200303014658960301453530030146589703014695980301469597030146959903014535290301472646030147265103014767330301492152030148736403014873630301485883030148588403014879640301487965030148140503014921530301501411
- Batch Numbers
- Amount recalled
- 1240 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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.
Free recall alerts
Get alerted about new Volcano Corporation recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.