The Recall Desk
HighFDA (Devices)·Z-1738-2020·Announced 2020-04-29

Boston Scientific Recalls Stretch VL Ureteral Stent Sets

Boston Scientific is recalling 50 units of Stretch VL Ureteral Stent Sets due to increased complaints about difficulty tracking over the guidewire, which may cause procedural delays.

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 is classified as FDA Class II and involves a risk-of-harm product (procedural delay) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.

Plain-English summary

Boston Scientific is recalling 50 units of the Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor (UPN: M006185156080). The affected lot number is 24724232. These devices were distributed nationwide and in foreign regions including Europe, the Middle East and Africa, the Americas, Asia Pacific, and Japan.

The recall was initiated due to an increase in the rate of complaints regarding difficulty or inability to track over the guidewire. This issue may result in a procedural delay due to the need to exchange the affected device. The FDA has classified this as a Class II recall.

Healthcare providers and facilities that have received these specific stent sets should stop using them and contact Boston Scientific for further instructions on how to return or exchange the devices.

The recalled product

Product
Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080
Manufacturer
Boston Scientific
Affected units
50

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 (1)

  • Lot Numbers: 24724232

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 recalled by Boston Scientific 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 12 products in this recall →