The Trevo Trak 21 Microcatheter is a single-lumen recall
The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer…
Why was The Trevo Trak 21 Microcatheter is a single-lumen recalled?
Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton), different configurations, have been erroneously distributed to customers in the US.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model/Catalog Number: 90338 UDI Codes: (01)07613327313956(17)251125(10)0000590444 (01)07613327313956(17)260101(10)0000603275 Lot Numbers: 0000590444 0000603275
- Product
- The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer…
- Recalling firm
- Stryker Neurovascular
- Quantity
- 6
- Distribution
- U.S. Nationwide distribution in the states of CA and VA.
- Recall date
- October 16, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)