FDA Medical Device Recalls (openFDA)
Stryker Neurovascular: Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter
- Recall number
- Z-0347-2018
- Recalling firm
- Stryker Neurovascular
- Product
- Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter
- Status
- Terminated
- Initiated
- 2017-11-28
- Posted
- not on file
- Terminated
- 2020-04-28
- Reason
- Stryker Neurovascular has become aware that at least 1 (one) Trevo XP Provue System was manufactured where the carton sleeve did not match the physical contents of the pack.
- Root cause
- Packaging process control
- Action
- The affected consignees will be notified via letter sent a courier beginning 11/28/17. A response form has been provided which customers have been asked to complete, and correct affected product is being requested.
- Quantity
- not on file
- Distribution
- OUS only - NL, FR, IT, DE, BE
- Lot, serial or model codes
- UPN/Model No. 80052; Lot 63034
- 510(k) numbers
- ["K113260","K132641"]
- PMA numbers
- not on file
- Product code
- NRY
- Firm FEI
- 3008853977
- Firm city
- Fremont
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28