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Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF… recallZ-1085-2024 · Stryker, Inc. · initiated Dec 6, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stryker, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The microcatheter IFU contains an intended use that has not been evaluated by the FDA.

FDA root cause category: Under Investigation by firm

What the company is doing

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: [email protected]) 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 [email protected]

Recall details

Recall number
Z-1085-2024
Status
Open, Classified
Initiated by the company
Dec 6, 2023
Posted by the FDA
Feb 14, 2024
Recalling firm
Stryker, Inc.
Quantity
63 units
Product code
QJP
FDA submissions
K211594
Distribution
US Nationwide distribution in the states of AL, FL, GA, HI, IL, MI, NC, NH, OH, PA, TX, VA.

Product description

Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm

Code information (models, lots, serial numbers)

UDI: (01)07613327313956/Lot Number(s): 0000136913 0000144331, 0000163582, 0000164440, 0000182275, 0000230955, 0000240597, 0000244845, 0000370674

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 93678).

Sources and updates

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