Reported Feb 5, 2014 · Terminated
Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Sterilized using irradiation. Product Usage: This…
Boston Scientific 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: Boston Scientific Corporation · 47215 Lakeview Blvd · Fremont, CA · 94538-6530
Is this the product you have?
Atlantis PV8.5F15
- MHz Peripheral Imaging CatheterSterile, R; Sterilized using irradiation
- Product UsageThis catheter is a 15 MHz ultrasound imaging catheter intended to operate with an IVUS instrument for diagnostic imaging. It is used with an 8.5F-introducer sheath and a 0.035 guidewire
- Lot codes and dates
- Product numberH749364560
- Catalog number36456
- Lot numbers
161593581618396416230195162306731624726316257809162684981628917716311356163305431634282416419885164206241642090316447744164585361648613316494530
- Expiration DateJune 11th 2014 to October 29th 2014
- Amount recalled
- 1068 single units
Where it was sold
- Nationwide
Why it was recalled
Reports of physicians experiencing inability to pass a 0.035" guidewire through the guidewire lumen and exit port at the (proximal) Y-manifold of the imaging catheter.
This product could cause temporary or reversible health problems — stop using it.
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