The Recall Desk
ModerateFDA (Devices)·Z-1739-2020·Announced 2020-04-29

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

Boston Scientific is recalling 40 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 explicitly states no illnesses or injuries have been reported, and the hazard is limited to procedural delay rather than direct physical harm, fitting the criteria for a moderate severity score.

Plain-English summary

Boston Scientific is recalling 40 units of the Stretch VL Ureteral Stent Set 7FX22-30CM with .035 Sensor (UPN: M006185157080). The recall affects Lot Number 24755842. These medical 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 because the affected device needs to be exchanged. The source text does not report any illnesses, injuries, or deaths associated with this recall.

Healthcare providers and facilities that have received these specific stent sets should stop using them and contact Boston Scientific for instructions on how to return or exchange the devices. Patients who have had these stents placed should consult their healthcare provider if they have concerns about their procedure.

The recalled product

Product
Stretch VL Ureteral Stent Set 7FX22-30CM with .035 Sensor UPN: M006185157080
Manufacturer
Boston Scientific
Affected units
40

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: 24755842

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 →