Changeflow GovPing Pharma & Drug Safety Stryker InZone Detachment System Type II Recall...
Urgent Enforcement Amended Final

Stryker InZone Detachment System Type II Recall - Battery Drain

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Summary

Health Canada issued a Type II recall for Stryker Neurovascular's InZone Detachment System. Certain device lots may experience premature battery drain, causing devices to fail to power on, display faint indicators, or be unable to detach coils as intended. Healthcare providers should contact Stryker Neurovascular at 47900 Bayside Parkway, Fremont, CA 94538 to verify affected lot numbers and obtain additional information.

What changed

Health Canada issued a Type II health product recall for Stryker Neurovascular's InZone Detachment System. The recall addresses an issue where certain device lots may experience premature battery drain, potentially causing devices to fail to power on, display faint audible and visual indicators, or be unable to detach coils as intended during medical procedures.

Healthcare providers using these neurovascular devices should immediately verify whether their inventory contains affected lot numbers by contacting Stryker Neurovascular directly. Affected devices should be removed from use and replaced as appropriate. The recall applies to model/catalogue number M00345100950, with lot numbers available upon request from the manufacturer.

What to do next

  1. Contact Stryker Neurovascular to verify if devices are from affected lots
  2. Monitor for device malfunction including failure to power on or faint indicators
  3. Request additional information from manufacturer as needed

Archived snapshot

Apr 11, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Health product recall

Stryker InZone® Detachment System

Brand(s)

Stryker Neurovascular

Last updated

2026-04-10

Summary

Product Stryker InZone® Detachment System Issue Medical devices - Performance What to do Contact the manufacturer if you require additional information.

Audience Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
InZone® Detachment System More than 10 numbers, contact manufacturer. M00345100950

Issue

Stryker Neurovascular has identified an issue affecting certain lots of InZone® Detachment System devices. Stryker Neurovascular has observed that some devices may experience premature battery drain. When this occurs, the devices may:
• Not power on;
• Power on with faint audible and visual indicators;
• Be unable to detach a coil as intended.

Additional information

Details

Original published date:

2026-04-10

Alert / recall type Health product recall Category Health products - Medical devices - Neurology Companies Stryker Neurovascular

47900 Bayside Parkway, Fremont, California, United States, 94538

Published by Health Canada Audience Healthcare Recall class Type II Recall date

2026-04-01

Identification number RA-81872

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Battery Drain Issue InZone Detachment System Type II Recall

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Last updated

Classification

Agency
Health Canada
Filed
April 1st, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
RA-81872

Who this affects

Applies to
Medical device makers Healthcare providers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical device recall Device malfunction monitoring Neurovascular device inspection
Geographic scope
Canada CA

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Product Safety Healthcare

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