Company: PFSA
Filing Date: 2025-10-09
Form Type: S-1
Source: 0001213900-25-097860
Chunk: 56

Company: Profusa, Inc.
Filing Date: 2025-10-09
Form: S-1
Chunk 56
---
 recalls and correction 
 and removals;                                                                                             |

| ● | post-market approval studies; and |

| ● | product import and export. |

If the FDA determines that there is a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death, the agency may issue a cease distribution and notification order and a mandatory recall order. We may also decide to recall a product voluntarily if we find a material deficiency, including unacceptable risks to health, manufacturing defects, design errors, component failures, labeling defects, or other issues. Recalls of our products could divert the attention of our management and have an adverse effect on our reputation, financial condition, and operating results. We and certain of our suppliers are also required to comply with the FDA’s Quality System Regulation, or QSR, and other regulations which cover the methods and documentation of the design, testing, production, control, selection and oversight of suppliers or contractors, quality assurance, labeling, packaging, storage, complaint handling, shipping and servicing of our products. The FDA may enforce the QSR through announced (through prior notification) or unannounced inspections. Compliance with ongoing regulatory requirements can be complex, expensive and time-consuming. Failure by us or one of our suppliers or distributors to comply with statutes and regulations administered by the FDA, competent authorities and other regulatory bodies, or failure to take adequate response to any observations, could result in, among other things, any of the following actions:

| ● | warning letters or untitled letters that require corrective action; |

| ● | delays in approving, or refusal to approve, our systems; |

| ● | fines and civil or criminal penalties; |

| ● | unanticipated expenditures; |

| ● | FDA refusal to issue certificates to foreign governments needed to export our products for sale in other 
 countries;                                                                                               |

| ● | suspension or withdrawal of clearance or approval by the FDA or other regulatory bodies; |

| ● | product recall or seizure; |

| ● | administrative detention; |

| ● | interruption of production, partial suspension, or complete shutdown of production; |

| ● | interruption of the supply of components from our key component suppliers; |

| ● | operating restrictions; |

| ● | court consent decrees; |

| ● | FDA orders to repair, replace, or refund the cost of devices; |

| ● | injunctions; and |

| ● | criminal prosecution. |

32 The potential effect of these events can in some cases be difficult to quantify. If any of these actions were to occur,