Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm
This recall is currently active, issued February 14, 2024. It was issued by Stryker, Inc..
- Company
- Stryker, Inc.
- Recall Initiated
- December 6, 2023
- Posted
- February 14, 2024
- Recall Number
- Z-1084-2024
- Quantity
- 11 units
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
The microcatheter IFU contains an intended use that has not been evaluated by the FDA.
Distribution
US Nationwide distribution in the states of AL, FL, GA, HI, IL, MI, NC, NH, OH, PA, TX, VA.
Lot / Code Info
UDI: (01)00815742002386/Lot Number(s): 0000228865 0000370674
Root Cause
Under Investigation by firm
Action Taken
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