Autotome RX 44 recallZ-2350-2024 · Boston Scientific Corporation · initiated Jun 12, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
All customers notified via courier on June 12, 2024 - notice was titled "Urgent Medical Device Removal." Customers were informed to cease further use or distribution of any remaining affected product. Product should be segregated and returned to the firm. For more information, please reach out to your local Boston Scientific representative.
Recall details
- Recall number
- Z-2350-2024
- Status
- Open, Classified
- Initiated by the company
- Jun 12, 2024
- Posted by the FDA
- Jul 12, 2024
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 256 US, 39 OUS
- Product code
- KNS
- FDA submissions
- K013153
- Distribution
- Domestic distribution nationwide.
Product description
Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
Code information (models, lots, serial numbers)
UDI-DI (GTIN) 08714729444749 Lot 33280747 Expiration Date: January 23, 2027
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Autotome™ RX 44 M00545170Boston Scientific Corporation · Unit, electrosurgical, endoscopic (with or without accessories)1 recall262 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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