The Recall Desk
ModerateFDA (Devices)·Z-1737-2020·Announced 2020-04-29

Boston Scientific Recalls Stretch VL Ureteral Stent Sets Due to Tracking Issues

Boston Scientific is recalling 57 units of Stretch VL Ureteral Stent Sets because they may be difficult to track over a guidewire, potentially delaying procedures.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a procedural delay rather than a direct physical injury or hospitalization, fitting the criteria for a moderate severity issue involving low-risk operational complications.

Plain-English summary

Boston Scientific is recalling 57 units of the Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor (UPN: M006185155080). The recall is limited to Lot Number 24755840. The devices were distributed nationwide and in foreign regions including Europe, the Middle East, Africa, the Americas, Asia Pacific, and Japan.

The recall was initiated due to an increased rate of complaints regarding difficulty or inability to track the device over a guidewire. This issue may result in procedural delays if the affected device needs to be exchanged during a medical procedure.

Healthcare providers and facilities should identify any affected units in their inventory and stop using them. Boston Scientific is the recalling firm responsible for managing the recall process.

The recalled product

Product
Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080
Manufacturer
Boston Scientific
Affected units
57

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: 24755840

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 →