KEEOGO - CLINICIAN KIT 5062601Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07540162060007), received between Sep 18, 2025 and Sep 18, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Retraction Problem” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjurySep 18, 2025Retraction Problem; Retraction Problem

  ON (B)(6) 2025, DURING THE EXHOMESEP CLINICAL INVESTIGATION IN FRANCE (PROTOCOL ID-(B)(4), A 74-YEAR-OLD MALE SUBJECT (PATIENT ID: (B)(6)) WITH A PRE-EXISTING DIAGNOSIS OF PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS EXPERIENCED ACUTE CARDIAC SYMPTOMS WHILE PERFORMING A SUPERVISED REHABILITATION EXERCISE SESSION WITH THE KEEOGO DERMOSKELETON SYSTEM. AT 15:00, THE SUBJECT DEVELOPED RETROSTERNAL CONSTRICTIVE CHEST PAIN RADIATING TO THE JAW AND LEFT ARM DURING THE SESSION. SYMPTOMS RESOLVED AFTER STOPPING THE EXERCISE. AT 20:00, CHEST PAIN RECURRED AT REST FOR ABOUT ONE HOUR, WITH BLOOD PRESSURE MEASURED AT 180 MMHG. ECG WAS INCONCLUSIVE. TROPONIN LATER TESTED POSITIVE (INCREASE FROM 10 NG/L TO 35 NG/L). ON (B)(6) 2025 AT 02:00, CHEST PAIN RECURRED AGAIN, REQUIRING ADMISSION TO THE CARDIOLOGY DEPARTMENT FOR SUSPECTED ANGINA/NSTEMI. THE EVENT WAS CLASSIFIED AS LIFE-THREATENING. ON (B)(6) 2025, AN ACUTE SUB-OCCLUSIVE STENOSIS AT THE OSTIUM OF THE SECOND MARGINAL ARTERY WAS IDENTIFIED AND TREATED BY ANGIOPLASTY WITH STENT IMPLANTATION (FU1). ON (B)(6) 2025, A SECOND ANGIOPLASTY WAS PERFORMED WITH STENT IMPLANTATION IN THE MID RIGHT CORONARY ARTERY FOR A SIGNIFICANT ULCERATED STENOSIS; PROCEDUR

  Patient problems: Chest Pain; Pain

  MAUDE report 23086519 ↗
• InjurySep 18, 2025Retraction Problem; Retraction Problem

  ON (B)(6) 2025, DURING THE EXHOMESEP CLINICAL INVESTIGATION IN FRANCE (PROTOCOL ID-RCB 2021-A03094-37), A 74-YEAR-OLD MALE SUBJECT (PATIENT ID: (B)(6) WITH A PRE-EXISTING DIAGNOSIS OF PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS EXPERIENCED ACUTE CARDIAC SYMPTOMS WHILE PERFORMING A SUPERVISED REHABILITATION EXERCISE SESSION WITH THE KEEOGO DERMOSKELETON SYSTEM. AT 15:00, THE SUBJECT DEVELOPED RETROSTERNAL CONSTRICTIVE CHEST PAIN RADIATING TO THE JAW AND LEFT ARM DURING THE SESSION. SYMPTOMS RESOLVED AFTER STOPPING THE EXERCISE. AT 20:00, CHEST PAIN RECURRED AT REST FOR ABOUT ONE HOUR, WITH BLOOD PRESSURE MEASURED AT 180 MMHG. ECG WAS INCONCLUSIVE. TROPONIN LATER TESTED POSITIVE (INCREASE FROM 10 NG/L TO 35 NG/L). ON (B)(6) 2025 AT 02:00, CHEST PAIN RECURRED AGAIN, REQUIRING ADMISSION TO THE CARDIOLOGY DEPARTMENT FOR SUSPECTED ANGINA/NSTEMI. THE EVENT WAS CLASSIFIED AS LIFE-THREATENING. THE PATIENT REMAINED HOSPITALIZED IN STABLE CONDITION AT THE TIME OF REPORTING. THE KEEOGO DEVICE WAS INSPECTED BY THE STUDY TEAM AND CONFIRMED TO BE FUNCTIONING PROPERLY BEFORE, DURING, AND AFTER THE INCIDENT, WITH NO DEFECT OR MALFUNCTION IDENTIFIED. THE INVESTIGATOR NOTED THE POSSIBILITY THAT THE PHYSIC

  Patient problems: Chest Pain

  MAUDE report 23085338 ↗