Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective c
Summary
The FDA issued a Class II for Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M005 by Boston Scientific Corporation. Reason: Foreign material may be present on the enclosed section of the cutting wire which may lead to inability to optimally bow the sphincterotome. This issu.
Details
Source
Device Recall
External ID
Z-2350-2024
Action Date
2024-07-24
Status
Ongoing
Category
device
Product Description
Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
Lot/Code Info: UDI-DI (GTIN) 08714729444749 Lot 33280747 Expiration Date: January 23, 2027
Quantity Affected: 256 US, 39 OUS
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.
Distribution
Domestic distribution nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-12
Company
Marlborough, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 198 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Boston Scientific Corporation has 399 FDA actions in our database, including 334 recalls and 65 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Boston Scientific Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Boston Scientific Corporation have FDA actions?
Boston Scientific Corporation has 399 FDA actions in our database, including 334 recalls and 65 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2350-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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