Kiwi Vacuum Assisted Delivery System Recall - Breakage Hazard
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
- Identify whether your facility has the Kiwi Vacuum Assisted Delivery System (VAC-6000MT) in inventory
- Discontinue use of affected devices pending manufacturer instructions
- 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)
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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