Lower riskMedical device recall · FDA · Published June 12, 2024
Boston Scientific Autotome RX 20mm Sphincterotome Recall: Foreign Material Risk
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.
Take action
Contact the company
📍Recalling firmBoston Scientific Corporation100 Boston Scientific Way · Marlborough, MA 01752-1234
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/54878-boston-scientific-autotome-rx-20mm-sphincterotome-recall-foreign-material-risk.
“Boston Scientific Autotome RX 20mm Sphincterotome Recall: Foreign Material Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54878-boston-scientific-autotome-rx-20mm-sphincterotome-recall-foreign-material-risk. Based on FDA recall #Z-2350-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2350-2024%22&limit=1).
The FDA announced on June 12, 2024, that Boston Scientific Corporation is recalling the Autotome RX 20mm CUT WIRE Cannulating Sphincterotome due to foreign material on the cutting wire. This defect may prevent optimal bowing of the device and prolong procedures.
Foreign material may be present on the enclosed section of the cutting wire, which may lead to an inability to optimally bow the sphincterotome. This issue may lead to prolongation of procedure.
Context
GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since June 1, 2017. Other recent recalls include the Imager II Angiographic Catheters Recall (August 24, 2026), the LUX-Dx Cardiac Monitor System Recall (August 6, 2026), and the StoneSmart Connect Console Power Adapters Recall (July 22, 2026). Other recent recalls of similar products include the Medtronic Bio-Medicus Adult Cannula Kit Recall (May 25, 2026), the Wilson-Cook Teslatome Sphincterotomes Recall (December 18, 2025), and the CleverCut Single Use Sphincterotome V Recall (January 7, 2026).
How to tell if you have this one
Check for the Material Number (UPN) M00545170 on the device. The product was sold with lot number 33280747 and expires January 23, 2027.
Brand
Boston Scientific
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Details
Look for the Material Number (UPN) M00545170 on the device to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Domestic distribution nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2350-2024 (June 12, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2350-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.