Recall Z-1734-2020— Boston Scientific

Name: FDA recall Z-1734-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-09

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific, initiated 2020-03-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110. Reason: 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.

Recalling firm: Boston Scientific
Classification: Class II
Status: Ongoing
Initiated: 2020-03-09
Firm location: Marlborough, MA, United States

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.