EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilat
FDA device recall Z-0225-2025 · posted 2024-10-25 · Open, Classified
Recall details
- Recalling firm
- Olympus Corporation of the Americas
- 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
- Action taken
- Olympus 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- FGE
- Quantity affected
- 209 units
- Distribution
- Worldwide 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.
- Date initiated
- 2024-09-13
- Date posted
- 2024-10-25
- Location
- Center Valley, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter (K180086) | Gyrus Acmi, Inc. | 2018-03-08 |