Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Trevo Trak 21 Microcatheter

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Trevo Trak 21 Microcathetersee related information
Date Initiated by FirmAugust 30, 2024
Date PostedOctober 07, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0021-2025
Recall Event ID 95314
510(K)NumberK211594 
Product Classification Catheter, Percutaneous, Neurovasculature - Product Code QJP
ProductThe Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization. A rotating hemostatic valve with side-arm adapter is provided with each microcatheter.
Code Information Model/Catalog Number: 90338 UDI Codes: (01)07613327313956(17)251125(10)0000590444 (01)07613327313956(17)260101(10)0000603275 Lot Numbers: 0000590444 0000603275
Recalling Firm/
Manufacturer		 Stryker Neurovascular
47900 Bayside Pkwy
Fremont CA 94538-6515
For Additional Information ContactAngel Moreno
510-413-2500
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 09/12/2024, the firm sent via FedEx an "URGENT: MEDICAL DEVICE RECALL - Customer Notification" Letter to customers informing them that certain lots of Trevo Trak 21 Microcatheters were shipped with the incorrect configuration. The affected products contained Instructions for Use (IFUs) and product labels for international use, instead of the United States (US). The International IFUs contain intended uses that have not been cleared/approved for the U.S. market. Customer are instructed to: 1. Immediately check internal inventory for affected devices. 2. When using impacted lot(s) of Trevo Trak 21 Microcatheters, follow the US IFU attached in this communication NV00055463-02 (Attachment A) instead of the one that originally came with the device. 3. Circulate recall notification internally to all interested/affected parties and post this customer notification on or near affected products. 4. Maintain awareness of this communication internally until all required actions have been completed within your facility. 5. Inform Stryker Neurovascular if the subject devices have been distributed to other organizations and provide contact details so that Stryker Neurovascular can inform the recipients appropriately. 6. Inform Stryker Neurovascular of any adverse events concerning the use of the subject devices. (US Customer Service: 1-855-91-NEURO (1-855-916- 3876), Email: NVCustomerCare@stryker.com). 7. Complete the attached customer response form. It may be that you no longer have any physical inventory on site. Completing this form allow for updating records and will also negate the need to send any further unnecessary communications on this matter. 8. Email the completed form to nvfieldactions@stryker.com. Contact the local Stryker representative, send an email to nvfieldactions@stryker.com or call US Customer Service: 1-855-91-NEURO (1-855-916-3876) for further assistance related to this Medical Device Recall Customer Notification.
Quantity in Commerce6
DistributionU.S. Nationwide distribution in the states of CA and VA.
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 = QJP
-
-