Boston Scientific recalls Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor (UPN: M006192132080) due to difficulty tracking over guidewire, potentially causing procedural delays.
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
Boston Scientific is recalling Polaris Ultra Ureteral Stent Sets with specific model numbers because they may cause difficulty tracking over the guidewire during procedures. This could lead to procedural delays and require device exchange.
The stent set may cause difficulty tracking over the guidewire during medical procedures. This can lead to procedural delays and may require exchanging the device.
Urology patients undergoing procedures involving this stent set are most at risk. Healthcare providers using the affected model numbers should check their inventory.
Check for the model number 6FX24CM with .035 Sensor and UPN: M006192132080. Lot numbers 24749818 and 24913418 are also associated with this recall.
Identify the model number and lot numbers to confirm if your stent set is affected.
Boston Scientific recalls this stent set due to an increase in complaints about difficulty tracking over the guidewire, which may cause procedural delays.
Check the model number and lot numbers to see if it's affected. If it is, contact Boston Scientific for further instructions.
The recall is for procedural delays and device exchange, not a risk of serious injury. The hazard level is low risk.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1740-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1740-2020 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
