Boston Scientific recalls Stretch VL Ureteral Stent Sets with difficulty tracking guidewires, potentially causing procedural delays. Affected units have specific lot numbers and UPN.
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 certain Stretch VL Ureteral Stent Sets due to issues with tracking guidewires during procedures, which may cause delays requiring device exchange. This affects medical use cases where precise stent placement is critical.
The stent set may cause difficulty tracking the guidewire during procedures, leading to procedural delays. This could require exchanging the device, but does not cause injury or death in normal use.
Healthcare professionals using the stent set during urological procedures are most at risk. Patients receiving the device are not directly affected by the hazard.
Check for the model number 4.8FX22-30CM with .035 Sensor and UPN M006185155080. Affected units have lot numbers starting with 24755840.
Identify the model number 4.8FX22-30CM with .035 Sensor and UPN M006185155080.
Boston Scientific recalls these stent sets due to increased complaints about difficulty tracking the guidewire, which may cause procedural delays requiring device exchange.
No, the recall does not require stopping use. The hazard may cause procedural delays but does not pose a risk of injury or death.
Check for the model number 4.8FX22-30CM with .035 Sensor and UPN M006185155080. Affected units have lot numbers starting with 24755840.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1737-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1737-2020 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.