inCourage® ICS-1M-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841561102778), received between Nov 24, 2017 and Jan 19, 2022 — classified as 2 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN INCOURAGE DEVICE CAUSED A STROKE IN THE PATIENT'S EYE DURING THERAPY. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Stroke/CVA

  MAUDE report 13289386 ↗
• InjuryNov 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RESPIRATORY TECHNOLOGIES RECEIVED INFORMATION DURING ROUTINE FOLLOW-UP THAT A PATIENT EXPERIENCED A RUPTURE OF ONE OF THE PATIENT'S SALINE BREAST IMPLANTS FOLLOWING THE USE OF THE INCOURAGE AIRWAY CLEARANCE THERAPY SYSTEM. THERE HAVE BEEN NO ADVERSE EVENTS REPORTED BY THE PATIENT IN THE MONTHS SINCE THE EVENT OCCURRED. THE PATIENT HAD CONSULTED WITH HER PHYSICIAN AND THE PHYSICIAN STATED THERE ARE NO RISKS DUE TO THE RUPTURE. THE INCOURAGE DEVICE HAS NOT YET BEEN RETURNED FOR ANALYSIS, BUT PRODUCT RETURN IS EXPECTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7057949 ↗