36C24226Q0114.docx

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6515--Intent to Sole Source VitalFlow System **EMERGENCY**
Solicitation number
36C24226Q0114
Issued by

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This is a Special Notice for a sole source contract issued by the Department of Veterans Affairs WNY Healthcare System. The notice indicates an intent to award a Firm Fixed Price contract to Medtronic USA, Inc. for a single Vitalflow Capital Heart Lung Bypass unit, valued at an unspecified amount. The procurement is driven by FDA recommendations and multiple recalls of the current CardioHelp Heart-Lung Bypass unit, which has left the medical center's operating room without a functional heart-lung bypass device.

The solicitation (Number 36C24226Q0114) is classified as an emergency procurement under FAR 6.302-2 for "unusual and compelling urgency," with a response date of 11-11-2025 at 4:00 PM Eastern Time. The contract will be awarded directly to Medtronic without competitive bidding, with the primary goal of ensuring veterans receive optimal medical treatment. The procurement is specific to the Buffalo VA Medical Center and adheres to Veterans Health Administration guidelines prohibiting the use of gray market medical equipment.

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Special Notice Special Notice This is a notice of intent to award a sole source contract and is not a request for quotes.

The Department of Veterans Affairs WNY Healthcare System intends to award a Firm Fixed Price Sole-Source action to:

Name of Contractor:
Medtronic USA, Inc
Street Address:
710 Medtronic Parkway NE
City, State, Zip:
Minneapolis, MN 55432

The Buffalo VA Medical Center is working to replace the current Cardiohelp Heart-Lung Bypass unit. The FDA has issued a notice recommending the replacement of these units. There have been multiple recalls on these devices that the vendor has failed to remediate which has led to this decision by the FDA. Currently, our OR has no Heart- Lung Bypass unit to use. Therefore, the Buffalo VAMC is seeking to purchase one (1) Vitalflow Capital – Heart Lung Bypass unit to conform with FDA replacement recommendation. Procuring this equipment will ensure device uptime in our OR so that Veterans are receiving the best care possible.

Because of the multiple recalls issued on our current CardioHelp Heart-Lung Bypass unit, the OR has been operating without a Heart-Lung bypass unit. It is crucial that we get this procured as soon as possible due to the limited treatment that can be provided to veterans. So, it is imperative that we sole source to Medtronic, Inc for the reason of getting the OR a functioning Heart-Lung Bypass unit. This is a Emergency Procurement IAW FAR 6.302-2 – Use of other than full and open competition for “unsual and compelling urgency”.

This notice of intent to award a sole source contract is not a request for competitive proposals. There will be no solicitation available for competitive quotes.

Special Notice Special Notice The Veterans Health Administration prohibits the use of gray market items in their Medical Centers. Gray market items are considered to be items outside of the original equipment manufacturer’s intended distribution channels.

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Special Notice

Special Notice

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SUBJECT*
Intent to Sole Source VitalFlow System **EMERGENCY**

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE*
13212
SOLICITATION NUMBER*
36C24226Q0114
RESPONSE DATE/TIME/ZONE
11-11-2025 4:00PM EASTERN TIME, NEW YORK, USA
ARCHIVE
45 DAYS AFTER THE RESPONSE DATE
RECOVERY ACT FUNDS
N
PRODUCT SERVICE CODE*
6515
NAICS CODE*
339112
CONTRACTING OFFICE ADDRESS
Department of Veterans Affairs

Network Contracting Office 02 1304 Buckley Road Suite 101 Syracuse NY 13212

POINT OF CONTACT*

Contract Specialist Ryan Seburn Ryan.Seburn@va.gov 315-751-6369

ADDITIONAL INFORMATION

AGENCY’S URL
https://www.va.gov/
URL DESCRIPTION
VA Homepage

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

See attached document: Sole Source JA- VitalFlow.

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Special Notice

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Special Notice

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