Z-0275-2018Class II

Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm)...

Name: Z-0275-2018 Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm)...
Creator: Stryker Neurovascular
Published: 2017-11-03
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2017-11-03 / Terminated / root cause: labeling and UDI

FDA source

Stryker Neurovascular began a recall of Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm), MICROCATHETER,150 cm, 6 cm; AXS Catalyst(TM) 6, Distal... on 2017-11-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0275-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-03
Posted: 2017-12-05
Terminated: 2019-11-04
Recalling firm: Stryker Corp.
Product: Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm), MICROCATHETER,150 cm, 6 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm, UPN M0033PK62523002 Stroke intervention kit
Product code: NRY Catheter, Thrombus Retriever
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: The firm, Stryker Neurovascular, sent an "Urgent Medical Device Voluntary Recall Immediate Action Required" letter initiating their recall on 11/01/2017. The letter described the product, problem and actions to be taken. The consignees were instructed to immediately check internal inventory; remove and discard the procedure pack carton sleeve; circulate notice; maintain awareness of notice internally until all required actions have been completed with your facility; inform Stryker of any subject devices distributed to other organization, and complete and return customer response form to your nominated Stryker Representative or to [email protected]. If you have any questions, call 510-413-2593; email: [email protected] or 510-413-2900.
Quantity in commerce: 2 units
Distribution: International Distribution to: Germany, Slovakia and Israel.
Product codes and lots: Lot Numbers: QXC10200044, exp. date 28-Aug-18; QXC10200043, exp. date 28-Aug-18

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0275-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0275-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-27	2017-12-21
Z-0276-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-27	2017-12-21
Z-0277-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-27	2017-12-21

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)