Skip to content

Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE… recallZ-0275-2018 · Stryker Neurovascular · initiated Nov 3, 2017

Class II Terminated All recalls posted in December 2017

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stryker Neurovascular or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Labeling Change Control

What the company is doing

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.

Recall details

Recall number
Z-0275-2018
Recall class
Class II
Status
Terminated
Initiated by the company
Nov 3, 2017
Posted by the FDA
Dec 5, 2017
Recalling firm
Stryker Neurovascular
Quantity
2 units
Product code
NRY
FDA submissions
K113260, K113778, K132641, K143077, K151667
Distribution
International Distribution to: Germany, Slovakia and Israel.

Product description

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

Code information (models, lots, serial numbers)

Lot Numbers: QXC10200044, exp. date 28-Aug-18; QXC10200043, exp. date 28-Aug-18

Other devices under the same FDA submission

5 devices cleared under K113260, K113778, K132641, K143077, K151667 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 78607).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page