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U.S. Department of Health and Human Services

Class 2 Device Recall EZDilate Wire Guided Balloon

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 Class 2 Device Recall EZDilate Wire Guided Balloonsee related information
Date Initiated by FirmSeptember 13, 2024
Date PostedOctober 25, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0225-2025
Recall Event ID 95400
510(K)NumberK180086 
Product Classification Stents, drains and dilators for the biliary ducts - Product Code FGE
ProductEZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy. Model/Catalog Number: BD-410X-1055
Code Information UDI-DI: 821925033238 Lot: 408987
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactCynthia Ow
647-9993203
Manufacturer Reason
for Recall		Mislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13 mm however the balloon is 8.5mm, 9.5mm and 10.5 mm and may result in prolonged surgery. All other labeling is correct for the balloon, including the Shelf Box with Front Box Label and Circular Star Label and the balloon Pouch
FDA Determined
Cause 2		Under Investigation by firm
ActionOlympus issued Urgent Medical Device Removal letter issued 9/13/24 to Endoscopy Department, Risk Management Department. Letter states reason for recall, health risk and action to take: 2. Examine your inventory and identify the above-listed device with the affected batch number. 3. Please contact Customer Service at 1-800-848-9024, option 2, to obtain a Return Material Authorization. Olympus will arrange for the return of your device to Olympus. When it is received, you will receive a credit for your affected device(s). 4. If you have further distributed this product, identify your customers, and forward them this notification. 5. Olympus requests that you acknowledge receipt of this letter. Access the Olympus recall portal to indicate that you have received this notification. a) Go to https://olympusamerica.com/recall b) Enter the recall number "0453 c) Complete the form as instructed. Olympus requests that you report any complaints, including any incorrect labeling, to the Olympus Technical Assistance Center (TAC) at 1-800-848-9024 (option 1). If you require additional information, please do not hesitate to contact me by e-mail at Cynthia.Ow@Olympus.com or by phone at (647) 999-3203.
Quantity in Commerce209 units
DistributionWorldwide Distribution: US distribution to states of: CA, FL, IL, NJ, NY, PA, TN, VA, WI; and Foreign OUS to countries of: CA, DE, IN, SG, Latin America.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FGE
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