Outset Medical, Inc.

Current report

If we or our suppliers fail to comply with ongoing FDA or other foreign regulatory authority requirements, or if we experience unanticipated problems with our products, these products could be subject to restrictions or withdrawal from the market.

Current report

Even though we have obtained 510(k) clearance for Tablo, it and any other product for which we obtain clearance or approval, and the manufacturing processes, post-market surveillance, post-approval clinical data and promotional activities for such product, will be subject to continued regulatory review, oversight, requirements, and periodic inspections by the FDA and other domestic and foreign regulatory bodies. In particular, we and our suppliers are required to comply with FDA’s Quality Management System Regulation (QMSR) and other regulations enforced outside the United States which cover the manufacture of our products and the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, storage and shipping of medical devices. The QMSR requires that each manufacturer establish a quality systems program by which the manufacturer monitors the manufacturing process and maintains records that show compliance with FDA regulations and the manufacturer’s written specifications and procedures relating to the devices. QMSR compliance is necessary to receive and maintain FDA clearance or approval to market new and existing products. Regulatory bodies, such as the FDA, enforce the QMSR and other regulations through periodic audits and inspections. The failure by us or one of our suppliers to comply with applicable statutes and regulations administered by the FDA and other regulatory bodies, or the failure to timely and adequately respond to any adverse inspectional observations or product safety issues, could result in, among other things, any of the following enforcement actions:

Current report

FDA untitled letters, FDA Form 483s, FDA warning letters, it has come to our attention letters, fines, injunctions, consent decrees and civil penalties;

Current report

customer notifications for repair, replacement, refunds;

Current report

recall, detention or seizure of our products;

Current report

refusing or delaying our requests for 510(k) clearance or PMA approval of new products or modified products;

Current report

withdrawal of 510(k) clearances or PMA approvals that have already been granted;

Current report

criminal prosecution.

Current report

For example, in the third quarter of 2026, the FDA conducted another post-market, quality management system inspection of our San Jose, California facility, following a prior similar inspection in 2023. At completion of this most recent inspection, the FDA issued a Form FDA-483 identifying certain inspectional observations. We intend to provide a complete response to the FDA to address these observations in a timely manner. There is no guarantee, however, that we will be able to successfully address these observations within a specified time frame or without incurring additional, and possibly significant, costs. The FDA may also supplement the Form FDA Form-483 with further regulatory communications or actions related to the most recent observations, and any future inspections of our facility by the FDA may result in other observations, any of which could adversely affect our business.

Current report

The FDA can also publish Safety Communications or Letters to Health Care Providers when the agency becomes aware of new issues involving a specific product or, or more broadly, a product family. These communications are posted on the FDA’s website and describe the FDA’s analysis of a current issue and provide specific regulatory approaches and clinical recommendations for patient management. If any of these actions were to occur it would harm our reputation and cause our product sales and profitability to suffer and may prevent us from generating revenue. Furthermore, our key component suppliers may not currently be or may not continue to be in compliance with all applicable regulatory requirements which could result in our failure to produce our products on a timely basis and in the required quantities, if at all.

Current report

In addition, we are required to conduct costly post-market testing and surveillance to monitor the safety or effectiveness of our products, and we must comply with medical device reporting requirements, including the reporting of adverse events and malfunctions related to our products.

Current report

Later discovery of previously unknown problems with our products, including unanticipated adverse events or adverse events of unanticipated severity or frequency, manufacturing problems, or failure to comply with regulatory requirements such as QMSR, may result in changes to labeling, restrictions on such products or manufacturing processes, withdrawal of the products from the market, voluntary or mandatory recalls, a requirement to repair, replace or refund the cost of any medical device we manufacture or distribute, fines, suspension of regulatory approvals, product seizures, injunctions or the imposition of civil or criminal penalties which would adversely affect our business, operating results and prospects.

Current report

Item 5. Other

Current report

Information.

Current report

On August 5, 2026, the Company entered into an Amendment No. 1 to Credit Agreement and Guaranty and Warrant Certificate with Perceptive Credit Holdings IV, LP to (i) amend the covenant to achieve certain trailing twelve-month net revenue targets in the Perceptive Credit Agreement and (ii) reset the exercise price of the Closing Date Warrant to $4.838.

Current report

The foregoing summary of certain terms of such amendment does not purport to be complete and is qualified in its entirety by reference to the complete text of such amendment, a copy of which is filed as Exhibit 4.4 hereto and is incorporated herein by reference.

Previous report

Item 5. Other Information.

Previous report

None.