Boston Scientific Recalls Polaris Ultra Ureteral Stent Sets
Boston Scientific is recalling 19 Polaris Ultra Ureteral Stent Sets due to an increased rate of complaints regarding difficulty tracking over the guidewire.
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. The hazard involves a procedural delay due to device malfunction, which fits the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Boston Scientific is recalling 19 units of the Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor (UPN: M006192132080). The affected units are identified by lot numbers 24749818 and 24913418. The recall was initiated due to an increase in the rate of complaints regarding difficulty or inability to track the device over the guidewire.
The affected devices were distributed nationwide and internationally to Europe, the Middle East and Africa, the Americas (North and South America), Asia Pacific, and Japan. The source text does not specify specific dates of distribution or the exact number of units distributed in each region.
Healthcare providers and facilities should stop using the affected devices. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences. No specific instructions for consumers are provided in the source text, as the product is a medical device intended for professional use.
The recalled product
- Product
- Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080
- Manufacturer
- Boston Scientific
- Category
- Medical Device — Urological
- Affected units
- 19
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 (2)
- Lot Numbers: 24749818
- 24913418
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.
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