Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Shea
FDA device recall Z-1071-2025 · posted 2025-02-11 · Open, Classified
Recall details
- Recalling firm
- Olympus Corporation of the Americas
- Reason for recall
- Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
- Action taken
- Olympus notified consignees on about 01/15/2024, via letter. Consignees were instructed to examine inventory and quarantine affected devices, cease usage of the product immediately, acknowledge receipt of the letter through the Olympus web portal, and to forward the notice to all applicable personnel and customers if further distributed.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- EOQ
- Quantity affected
- 454 units
- Distribution
- US nationwide distribution.
- Date initiated
- 2025-01-15
- Date posted
- 2025-02-11
- Location
- Center Valley, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13 (K060243) | Olympus Medical Systems Corporation | 2006-06-23 |