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Kiwi Vacuum Assisted Delivery System Recall - Breakage Hazard

Favicon for recalls-rappels.canada.ca Health Canada Recalls & Safety Alerts
Filed March 10th, 2026
Detected April 2nd, 2026
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Summary

Health Canada issued a Type II recall for Clinical Innovations' Kiwi® Vacuum Assisted Delivery System (model VAC-6000MT) due to a breakage hazard at the Traction Force Indicator joint during use. The device may break when traction is applied at approximately a 45-degree angle, posing a risk during obstetric procedures. Manufacturers will contact affected customers with instructions for product return.

What changed

Health Canada has initiated a Type II recall for the Kiwi® Vacuum Assisted Delivery System (model VAC-6000MT) manufactured by Clinical Innovations, LLC of Murray, Utah. The recall addresses a potential breakage hazard at the Traction Force Indicator joint that may occur when traction is applied at approximately a 45-degree angle during delivery procedures. Health Canada classifies this as a Type II recall, indicating potential temporary or reversible health consequences. The original recall was published on 2026-04-01 with identification number RA-81826.

Healthcare providers and facilities should immediately identify whether they possess any units of the affected Kiwi® Vacuum Assisted Delivery System. All use of the affected product should be discontinued pending further instructions. Facilities should await contact from Clinical Innovations regarding return procedures and ensure that staff involved in obstetric care are aware of this safety concern. While no specific compliance deadline is stated, immediate action to identify and segregate affected inventory is warranted given the device failure risk during critical obstetric procedures.

What to do next

  1. Identify whether your facility has the Kiwi Vacuum Assisted Delivery System (VAC-6000MT) in inventory
  2. Discontinue use of affected devices pending manufacturer instructions
  3. Await contact from Clinical Innovations for return authorization and follow return procedures

Source document (simplified)

Health product recall

Kiwi® Vacuum Assisted Delivery System

Brand(s)

Clinical Innovations. LLC

Last updated

2026-04-01

Summary

Product Kiwi® Vacuum Assisted Delivery System Issue Medical devices - Performance What to do Manufacturer will contact custmers with instructions on return of affected products.

Audience Healthcare

Affected products

| Affected products | Lot or serial number | Model or catalogue number |
| --- | --- | --- |
| Kiwi® Vacuum Assisted Delivery System | Contact the manufacturer. | VAC-6000MT |

Issue

The device may break at the Traction Force Indicator (TFI) joint during use when traction is applied at approximately a 45-degree angle.

Additional information

Details

Original published date:

2026-04-01

Alert / recall type Health product recall Category Health products - Medical devices - Obstetrics and gynaecology Companies Clinical Innovations, LLC

747 West 4170 South, Murray, Utah, United States, 84123

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

2026-03-10

Identification number RA-81826

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Named provisions

Kiwi® Vacuum Assisted Delivery System Traction Force Indicator (TFI) Joint

Classification

Agency
Health Canada
Filed
March 10th, 2026
Instrument
Enforcement
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
RA-81826

Who this affects

Applies to
Healthcare providers Medical device makers
Industry sector
3345 Medical Device Manufacturing 6211 Healthcare Providers 6221 Hospitals & Health Systems
Activity scope
Medical Device Distribution Obstetric Device Usage
Geographic scope
Canada CA

Taxonomy

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

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