Z-0347-2018Class II

Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter

Name: Z-0347-2018 Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter
Creator: Stryker Neurovascular
Published: 2017-11-28
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2017-11-28 / Terminated / root cause: packaging

FDA source

Stryker Neurovascular began a recall of Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter on 2017-11-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0347-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-28
Posted: 2018-01-14
Terminated: 2020-04-28
Recalling firm: Stryker Corp.
Product: Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter
Product code: NRY Catheter, Thrombus Retriever
Reason for recall: 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 tag: packaging
FDA 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.
Distribution: OUS only - NL, FR, IT, DE, BE
Product codes and lots: UPN/Model No. 80052; Lot 63034

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0347-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0347-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-24	2018-01-14

Product code NRY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)