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U.S. Department of Health and Human Services

Class 2 Device Recall Trevo Trak 21

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  Class 2 Device Recall Trevo Trak 21 see related information
Date Initiated by Firm December 06, 2023
Date Posted February 14, 2024
Recall Status1 Open3, Classified
Recall Number Z-1085-2024
Recall Event ID 93678
510(K)Number K211594  
Product Classification Catheter, Percutaneous, Neurovasculature - Product Code QJP
Product Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
Code Information UDI: (01)07613327313956/Lot Number(s): 0000136913 0000144331, 0000163582, 0000164440, 0000182275, 0000230955, 0000240597, 0000244845, 0000370674
Recalling Firm/
Manufacturer		 Stryker, Inc.
4870 West 2100 South
Salt Lake City UT 84104
For Additional Information Contact Angel Moreno
801-974-1700
Manufacturer Reason
for Recall		 The microcatheter IFU contains an intended use that has not been evaluated by the FDA.
FDA Determined
Cause 2		 Under Investigation by firm
Action On December 22, 2023, Stryker Neurovascular issued a "Urgent: Medical Device Recall" notification to affected consignees. Stryker asked consignees to take the following actions: Immediately check your internal inventory for affected devices. 2. The affected items may continue to be used. 3. When using impacted lot(s) of Trevo Trak 21 or Trevo Pro 18 microcatheter, please follow the IFU attached in this communication instead of the one that originally came with the device. 4. Circulate this Customer Notification internally to all interested/affected parties. 5. Maintain awareness of this communication internally until all required actions have been completed within your facility. 6. Inform Stryker if any of the subject devices have been distributed to other organizations. If yes, provide contact details so that Stryker can inform the recipients appropriately. 7. Please inform Stryker 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) 8. Complete the attached customer response form. It may be that you no longer have any physical inventory on site. Completing this form will allow us to update our records and will also negate the need for us to send any further unnecessary communications on this matter. 9. Email the completed form to nvfieldactions@stryker.com
Quantity in Commerce 63 units
Distribution US Nationwide distribution in the states of AL, FL, GA, HI, IL, MI, NC, NH, OH, PA, TX, VA.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = QJP and Original Applicant = Stryker Neurovascular
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