FDAClass IIApril 29, 2020

Percuflex Plus Ureteral Stent Set 7FX24CM with .035 recall

Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M006175272080 (edited 1/13/2021)

Why was Percuflex Plus Ureteral Stent Set 7FX24CM with .035 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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: 24958079 (edited 1/13/2021)

Product
Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M006175272080 (edited 1/13/2021)
Recalling firm
Boston Scientific
Quantity
5 units
Distribution
Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan
Recall date
April 29, 2020
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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