Supply Chain

Managing supplies is a crucial part of moving medical products from the manufacturer to patient’s bedside. Efficient supply chains can reduce healthcare costs and make medical devices more affordable for patients and health systems. This news page includes content on supply shortages, inventory management, and procurement practices.

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FDA alerts public to Medtronic device recall after 33 injuries

An urgent device recall has been issued on Bravo CF, a line of pH capsules that are placed in the esophagus to aid in understanding the effects of acid reflux. Due to a dangerous manufacturing error, certain lots of the devices must be quarantined immediately.

FDA issues Class I recall on GE Carestations due to ventilation issue

The issue stems from a mode on the ventilation systems malfunctioning. Although no devices need to be removed from care settings, some will require repair.

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FDA issues emergency recall on resuscitation systems due to failure code

A specific model of AutoPulse resuscitation system manufactured by Zoll is prone to a failure code that could result in inadequate chest compressions being administered to patients. The affected kits must be removed from the supply chain immediately.

Ivenix infusion kits recalled by FDA due to serious manufacturing defect

Lines included in the kits were misassembled and could result in a botched blood transfusion. Due to the risk of serious injury or death, the recall has been designated as Class I.

FDA recalls pediatric breathing kits after eight serious injuries

Endotracheal tubes inside Medline neonatal intubation kits have been deemed too narrow, putting newborn patients at risk for hypoxia. This recall has been given the most serious FDA designation due to the risk of death.

the words "FDA recall" on a board

FDA recalls Zyno infusion pumps, citing risk of death

Some infusion systems manufactured by Zyno Medical were released with unapproved software that could cause safety features to malfunction. Use of any device subject to the recall is to cease immediately. 

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PBM lobby files lawsuit to block Arkansas law

The Pharmaceutical Care Management Association—a trade lobby representing pharmacy benefit managers—argues a state law that would force companies to divest from drugstores could leave patients without access to critical medications.

Multiple anesthesia breathing kits recalled by FDA due to risk of death

Multiple kits manufactured by Draeger are subject to a recall and an updated set of use instructions due to the risk of cracks developing in hoses that can cause inadequate ventilation.

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Around the web

Cardiovascular Business
Heartflow, a leader in AI-powered imaging evaluations, files for IPO

Heartflow, known for its AI-based CCTA evaluations, appears to be going public. The news follows years of momentum for the California-based company, including improved Medicare reimbursements for cardiac CT and a new Category I CPT code for its Plaque Analysis software.

Cardiovascular Business
ASNC lobbies Congress to curb prior authorization, oppose AUC mandates and embrace payment reform

Suman Tandon, MD, an American Society of Nuclear Cardiology board member, explains the group's call on Congress to update a number of healthcare policies. 

Cardiovascular Business
CMS proposal includes cardiologist pay bump—cuts to high-value services still a concern

The 2026 MPFS proposed rule includes higher conversion factors across the board. However, some cardiology groups remain concerned about a series of reimbursement reductions for high-value cardiology services.