The FDA announced on 2017-11-03 that Stryker Neurovascular voluntarily recalled certain Stroke Fast Pack and Trevo procedure packs because label contents did not match physical items, according to the FDA. The recall involves international distribution to Germany, Slovakia and Israel.
How to tell if you have it
- Brand: Stryker
- Product: Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 mm; Trevo(TM) Pro 18, TREVO PRO 18 MICROCATHETER, 0.021 in ID, 150 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm
- UPN: M0033PK42022002
- Lot Numbers: QPC30200039 (Exp. Date 28-Aug-18), QPC30200114 (Exp. Date 28-Mar18)
- Quantity: 2 units
The hazard
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, according to the FDA.
Context
GovInfoNow's records show Stryker Neurovascular has 16 other recalls on record since 2017-06-26. Other recent recalls of similar products include Bard Ureteral Stent Kit Recall: Label Size Mismatch Risk (2025-11-06) and Covidien Shiley Tracheostomy Tube Recall: Incorrect Box Labeling (2026-04-15).