COMPEX 2540660Recalls & reported problems
Djo, LLC · COMPEX WIRELESS USA COMPLETE SET · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888912290463), received between Jul 10, 2017 and Jul 10, 2017 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PLAINTIFFS COUNSEL CLAIMS IN THE COMPLAINT THAT "ELECTRODE STIMULATION PROVED TO BE DANGEROUSLY HIGH, CAUSING MR. (B)(6)'S BICEP TO FORCEFULLY AND UNNATURALLY CONTRACT TO A DANGEROUS DEGREE AND PROCEEDED TO INJURE OUR CLIENT. IMPRESSION: ROTATOR CUFF TENDINOSIS WITH MILD INTRASUBSTANCE PARTIAL TEARING. THERE IS NO FULL THICKNESS TEAR PRESENT. MILD SUBACROMIAL AND SUBDELTOID BURSITIS. THERE IS A COMPLETE TEAR OF THE BICEPS TENDON WITH THE PROXIMAL PORTION OF THE BICEPS EXTENDING ANTERIORLY AND SUPERIOR TO THE SUBSCAPULARIS MUSCLE BUNDLE. SUPERIOR LABRAL TEARING. GLENOHUMERAL JOINT EFFUSION. ACROMIOCLAVICULAR JOINT HYPERTROPHY AND INFLAMMATION". QUESTIONNAIRE NOT RECEIVED FROM CLINICIAN AND/OR PATIENT. DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION.
Patient problems: Pain
MAUDE report 6697220 ↗
Other STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING devices
- CoolTone 5034Zimmer MedizinSysteme GmbH · Stimulator, Muscle, Powered, For Muscle Conditioning9 reports
- miha bodytec miha bodytec m.ovemiha bodytec GmbH · Stimulator, Muscle, Powered, For Muscle Conditioning2 reports
- TENS 7000 Rechargeable DT7303Drive Devilbiss Healthcare · Stimulator, Muscle, Powered, For Muscle Conditioning2 reports
- COMPEX 11-2137Djo, LLC · STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page