Stryker recalls some Stroke Fast Packs and Trevo Procedure Packs due to mismatched carton labels and actual contents. Affected units may have incorrect contents, but no injury reports. Consumers should check labels and contact Stryker for details.
Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack.
Stryker is recalling certain Stroke Fast Packs and Trevo Procedure Packs because the labels on the cartons don't match what's inside. This mismatch could lead to using the wrong products during medical procedures, but no injuries have been reported.
The carton labels indicate different contents than what's actually inside the pack. This could cause medical staff to use the wrong device during a procedure, potentially leading to complications.
Medical professionals using these products for stroke interventions are most at risk. Patients using these devices are not directly affected by the mismatch.
Check for carton labels that say 'Stroke Fast Pack' or 'Trevo Procedure Packs' with specific sizes like 4 mm, 20 mm, or 0.021 in ID. The lot numbers QPC30200039 (exp. 28-Aug-2018) and QPC30200114 (exp. 28-Mar-2018) are affected.
Look for carton labels that list the product name and specific sizes, such as 'Stroke Fast Pack' with 4 mm, 20 mm, or 'Trevo Pro 18' with 0.021 in ID.
No injuries have been reported related to this recall.
Stroke Fast Packs, Trevo XP, TREVO XP PROVUE RETRIEVER, 4 mm, 20 mm, and Trevo Pro 18 with specific lot numbers QPC30200039 and QPC30200114.
No immediate action is required. Check the carton labels to ensure they match the contents before use.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-0276-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-0276-2018 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.