6515--Intent to Sole Source VitalFlow System **EMERGENCY**
Closed Special Notice Posted
- Solicitation number
- 36C24226Q0114
- Agency
-
Veterans Integrated Service Network 2
Veterans Health Administration, Department of Veterans Affairs
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 339112 Surgical and Medical Instrument Manufacturing
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Veterans Affairs Veterans Health Administration, specifically the Buffalo VA Medical Center under Veterans Integrated Service Network 2, has issued a notice of intent to award a sole source contract to Medtronic USA, Inc. This special notice, posted on November 6, 2025, announces an emergency procurement for one Vitalflow Capital Heart Lung Bypass unit valued at $92,795.00. The procurement is being conducted as a direct award without competitive bidding due to unusual and compelling urgency under FAR 6.302-2. The Buffalo VAMC's current Cardiohelp Heart-Lung Bypass unit has been rendered inoperable due to multiple FDA recalls and manufacturer failures to remediate defects, leaving the operating room without critical bypass capability.
The primary objective of this emergency procurement is to restore operational capacity in the VA medical center's operating room and ensure veterans receive comprehensive cardiac surgical care. The contract deadline for any interested parties to submit documentation is November 11, 2025, at 4:00 PM Eastern Time, though this is not a competitive solicitation and no alternative proposals will be accepted. Since this is a sole source award, there are no eligibility criteria for contractors to participate, as Medtronic has been pre-selected as the exclusive vendor. The VA's decision to pursue sole source procurement is driven by the critical nature of the equipment shortage and the specific FDA recommendation for replacement with the Vitalflow system. Additionally, all medical equipment procured must comply with Veterans Health Administration guidelines, which prohibit the use of gray market items sourced outside the original equipment manufacturer's intended distribution channels.
Notice text
Special Notice
Special Notice
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Special Notice
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Special Notice
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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.
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.
Files
| File | Type | Posted |
|---|---|---|
| Sole Source JA- VitalFlow.pdf | ||
| 36C24226Q0114.docx | DOCX document |
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