Stryker Neurovascular: Medical Device Recall in 2019 - (Recall #: Z-0065-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00815742000771

Product Classification:

Class II

Date Initiated: November 13, 2018

Date Posted: October 16, 2019

Recall Number: Z-0065-2020

Event ID: 83735

Reason for Recall:

Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter packaging

Status: Terminated

Product Quantity: 190 catheter guides

Code Information:

Lot number 0000010779; This lot was not distributed within the US

Distribution Pattern:

OUS distribution only: CZECH REPUBLIC, ITALIA, Netherlands, Sweden, Germany, Austria, Israel, France, Belgium, Finland, Switzerland, Portugal, Finland

Voluntary or Mandated:

Voluntary: Firm initiated