Z-2350-2024Class II

Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in...

Name: Z-2350-2024 Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in...
Creator: Boston Scientific Corporation
Published: 2024-06-12
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2024-06-12 / Open, Classified / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct on 2024-06-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2350-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-12
Posted: 2024-07-12
Recalling firm: Boston Scientific Corporation
Product: Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
Product code: KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 256 US, 39 OUS
Distribution: Domestic distribution nationwide.
Product codes and lots: UDI-DI (GTIN) 08714729444749 Lot 33280747 Expiration Date: January 23, 2027

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2350-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2350-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-24	2024-07-12

Product code KNS

K013153Class IIAutotome Rx Model # 4515, 4516Boston Scientific Corp / cleared 2001-10-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)