Reported Nov 9, 2016 · Terminated
Visualase Body Accessory Kit PN 020-3000. The individual components within the Visualase Body Accessory Kit are…
Medtronic Navigation, Inc.
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: Medtronic Navigation, Inc. · 826 Coal Creek Cir · Louisville, CO · 80027-9710
Is this the product you have?
- Visualase Body Accessory Kit PN 020-3000. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches. The packaged devices are then placed into a cardboard box which is labeled with the Body Accessory Kit label. Labeled sterile. The visualization stylet is constructed of titanium and used during Visualase laser ablation procedures by inserting it into intracorporeal catheter lumens for improved catheter stiffness and MRI visualization during procedures.
- Lot codes and dates
- Lot number 151591
- Amount recalled
- 100 total 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
Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Stylets and Visualase Body Accessory Kit because when the Visualization Stylet is placed in the magnetic field of a magnetic resonance imaging system it pulls and/or bends toward the field.
This product could cause temporary or reversible health problems — stop using it.
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