Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080
Reported: April 29, 2020 Initiated: March 9, 2020 #Z-1740-2020
Product Description
Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080
Reason for Recall
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
Details
- Recalling Firm
- Boston Scientific
- Units Affected
- 19 units
- Distribution
- Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080. Recalled by Boston Scientific. Units affected: 19 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 29, 2020. Severity: Moderate. Recall number: Z-1740-2020.
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