PlainRecalls
FDA Devices Moderate Class II Ongoing

Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110

Reported: April 29, 2020 Initiated: March 9, 2020 #Z-1734-2020

Product Description

Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110

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
32
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?
Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110. Recalled by Boston Scientific. Units affected: 32.
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-1734-2020.