Material Event Form 8 K

On December 11, 2024, Nuwellis, Inc. (the "Company") sent a notice to affected customers that it is voluntarily recalling specific lots of the AquaFlexFlow UF 500 Plus extracorporeal blood circuit which is used with the Aquadex Smartflow® or Aquadex FlexFlow® System. The lots are being recalled due to failures of the blood circuit associated with too many mismatch alarms. The blood circuits may indicate "Ultrafiltrate Weight Mismatch" or "Excessive Weight Mismatch" alarms while in use. If not addressed, this failure could result in excess fluid removal from a patient leading to Acute Volume Depletion. As of the date of this Current Report on Form 8-K, the Company is aware of five reported incidences of blood circuit product failures, with three leading to patient dehydration and requiring administration of fluids. The recall is being conducted with the knowledge of the U.S. Food and Drug Administration which has not yet characterized the Class of the recall.

Forward- Looking Statements

This Current Report on Form 8-K contains certain forward-looking statements within the meaning of Section 27A of the Securities Actof 1933, as amendedand Section 21E of the Exchange Actof 1934, as amended and Private Securities Litigation Reform Act, as amended, including those related to this voluntary recall and any future recall of the AquaFlexFlow UF 500 Plus extracorporeal blood circuit which is used with the Aquadex Smartflow or Aquadex FlexFlow System and any potential adverse events related to the recall(s).

These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "may," "should," "could," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the U.S. Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this Current Report on Form 8-K. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.