Nuwellis, Inc. Files 8-K

TL;DR

NUWE filed an 8-K, standard procedure, check for details.

AI Summary

Nuwellis, Inc. filed an 8-K on December 16, 2024, reporting other events. The company, formerly known as CHF Solutions, Inc. and Sunshine Heart, Inc., is incorporated in Delaware and headquartered in Eden Prairie, MN. The filing does not contain specific financial transactions or material events beyond its routine reporting nature.

Why It Matters

This 8-K filing indicates Nuwellis, Inc. is making a routine regulatory submission. Investors should review the details within the filing for any specific operational updates or disclosures.

Risk Assessment

Risk Level: low — The filing is a standard 8-K report and does not disclose any immediate material adverse events or significant financial changes.

Key Players & Entities

• Nuwellis, Inc. (company) — Registrant
• CHF Solutions, Inc. (company) — Former Company Name
• Sunshine Heart, Inc. (company) — Former Company Name
• Delaware (jurisdiction) — State of Incorporation
• Eden Prairie, MN (location) — Principal Executive Offices
• December 16, 2024 (date) — Date of Report

FAQ

Key Financial Figures

• $0.0001 — ich registered Common Stock, par value $0.0001 per share NUWE Nasdaq Capital Marke

Filing Documents

• ef20040192_8k.htm (8-K) — 28KB
• 0001140361-24-049660.txt ( ) — 160KB
• nuwe-20241216.xsd (EX-101.SCH) — 4KB
• nuwe-20241216_lab.xml (EX-101.LAB) — 21KB
• nuwe-20241216_pre.xml (EX-101.PRE) — 16KB
• ef20040192_8k_htm.xml (XML) — 4KB

01

Item 8.01 Other Events. 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 Act of 1933, as amended and Section 21E of the Exchange Act of 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

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Date: December 16, 2024 NUWELLIS, INC. By: /s/ Nestor Jaramillo, Jr Name: Nestor Jaramillo, Jr. Title: President and Chief Executive Officer

View Full Filing

View this 8-K filing on SEC EDGAR