The Recall Desk
HighFDA (Devices)·Z-0758-2021·Announced 2021-01-06

Boston Scientific Recalls Contour VL Ureteral Stent Sets Due to Nickel Debris

Boston Scientific is recalling 458 Contour VL Variable Length Ureteral Stent Sets because trace amounts of nickel debris were found on the devices during manufacturing.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a risk of harm (metallic debris) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Boston Scientific Corporation is recalling 458 units of the Contour VL Variable Length Ureteral Stent Set. The affected products are identified by specific GTINs and lot numbers, including lots 25928323, 25928324, 25928325, 25928326, 25933063, 25933064, 25933065, 25965814, and 25966020.

The recall was initiated because trace amounts of metallic debris were found on the stents related to the manufacturing process. The debris was confirmed to be particles of nickel. The products were distributed in the United States nationwide and in Japan.

Healthcare providers and patients should check their inventory and patient records for these specific lot numbers. If the affected stents are in use, providers should contact Boston Scientific for instructions on replacement or removal.

The recalled product

Product
Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190
Affected units
458

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • GTIN 08714729423768: Lots 25928323
  • 25928324. GTIN 08714729423829: Lots 25928325
  • 25928326
  • 25933063
  • 25933064

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →