Boston Scientific recalls Autotome RX 20mm CUT WIRE Cannulating Sphincterotome (UPN M00545170) due to potential foreign material causing procedure delays. Affected units sold with specific lot number and expiration date.
Foreign material may be present on the enclosed section of the cutting wire which may lead to inability to optimally bow the sphincterotome. This issue may lead to prolongation of procedure.
Boston Scientific is recalling its Autotome RX 20mm CUT WIRE Cannulating Sphincterotome because foreign material on the cutting wire might cause the device to not bend properly during procedures, leading to longer surgeries. This is a safety issue for medical professionals using the device in bile duct procedures.
Foreign material on the cutting wire can prevent the sphincterotome from bending correctly during procedures. This may cause the surgery to take longer than intended, potentially increasing patient risk without causing immediate injury.
Medical professionals who use this device during bile duct procedures are most at risk. The recall affects specific units with the Material Number (UPN) M00545170.
Check for the Material Number (UPN) M00545170 on the device. The product was sold with lot number 33280747 and expires January 23, 2027.
Look for the Material Number (UPN) M00545170 on the device to confirm if it is affected.
The recall indicates a potential risk of longer procedures due to foreign material on the cutting wire, but it does not cause immediate injury.
Check for the Material Number (UPN) M00545170 on the device. The product was sold with lot number 33280747 and expires January 23, 2027.
The recall does not specify a remedy, so contact Boston Scientific directly for guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2350-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2350-2024 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.
