FDAFDA · Food and drugs·Recall number Z-1740-2020
Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080
Published April 29, 2020 · Recall initiated: March 9, 2020
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific
- Distributor
- Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan
- Lot
- Lot Numbers: 24749818, 24913418
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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