Stryker Trevo XP ProVue Retriever Recalled for Core Wire Fracture
Stryker Neurovascular is recalling Trevo XP ProVue Retriever devices due to increased fracture complaints of the core wire, which can cause the stent retriever to separate and remain in the patient's vasculature.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect in a medical device that can lead to the device being left inside a patient's body, which constitutes a significant injury risk and fits the 'Severe' criteria for significant injury reports or structural defects.
Plain-English summary
Stryker Neurovascular is recalling the Trevo XP ProVue Retriever, a medical device used in neurovascular procedures. The recall affects 5,365 units distributed across the United States and numerous foreign countries. The specific reference numbers and lot codes for the affected devices are listed in the official recall documentation.
The recall was initiated due to an increase in complaints regarding the fracture of the flexible, tapered core wire. This defect can result in the stent retriever separating from the core wire during use. If this occurs, the stent retriever can be left behind in the patient's vasculature.
Healthcare providers and facilities that have received these devices should stop using them and contact Stryker Neurovascular for further instructions on the recall process.
The recalled product
- Product
- Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM); 90186 (6MM x 25MM). Procedure Pack REF: 80052, 93067, 93068, M0032PK42010001, M0033PK42022001, M0033PK43022001, M0033PK62523001, M0032PK42010002, M0032PK43010002, M0032PK62510002, M0033PK42022002…
- Manufacturer
- Stryker Neurovascular
- Category
- Medical Device — Neurovascular
- Affected units
- 5,365
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- REF/Lots: 90182/ 0000030024
- 0000030025
- 0000030026
- 0000030251
- 0000030252
- 0000030253
- 0000030408
- 0000030409
- 0000030410
- 0000030921
- 0000030922
- 0000030931
- 0000031336
- 0000031585
- 0000031761
- 0000031762
- 0000031763
- 0000032042
- 0000032043
- 0000032309
Distribution
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