EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1580
This recall is currently active, issued January 31, 2024. It was issued by Olympus Corporation Of The Americas.
- Recall Initiated
- November 10, 2023
- Posted
- January 31, 2024
- Recall Number
- Z-0936-2024
- Quantity
- 5232 units
- Firm Location
- Center Valley, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
Distribution
Nationwide. Foreign: AU BR BR CA DE HK IN JP SG
Lot / Code Info
UDI-DI: 00821925033191 Lot Numbers: 360910, 360911, 364014, 364158, 364338, 367646, 367647, 367648, 383363, 383846, 383847, 384058
Root Cause
Process control
Action Taken
Olympus issued Urgent Medical Device Removal Letter on 11/10/23. Firm issued a Correction letter dated December 1, 2023 to the letter of November 10, 2023 including Additional Lot numbers . Letter states reason for recall, health risk and action to take: 1. Inspect your inventory and identify any models and lots subject to this action. Please check all areas of the hospital to determine if any of these devices remain in inventory. Quarantine and cease use of the affected model/lots. Any models and lots that are not impacted can remain in inventory and be used. The model/lot number can be found on the box or pouch in Figure 1. 2. Call your Olympus customer service representative at 1-800-848-9024, option 2, with the quantity, model, and lot number of affected devices. Olympus will issue a Return Material Authorization to return any affected product at no charge. Olympus will issue a credit to your facility upon return of affected product. 3. 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: 0433 c. Complete the form as instructed. 4. If you have distributed these devices outside your facility, please notify your customers of this matter immediately. Your notification to your customers may be enhanced by including a copy of this letter. Olympus requests that you report complaints to our Technical Assistance Center (TAC) at 1-800-848-9024, option 1.