Chalgren 242-637-24TP-1Recalls & reported problems
Chalgren Enterprises · Injectable Monopolar Needle Electrode, EMG, 37mm x 26g · Class 2
Data updated Oct 18, 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 00816020020405), received between Jun 15, 2018 and Jun 15, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
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
Device problems
- Break1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 15, 2018Break
REPORT BY CUSTOMER THAT NEEDLE FROM INJECTABLE MONOPOLAR NEEDLE ELECTRODE BROKE OFF IN PATIENT WHILE PATIENT WAS RECEIVING BOTOX INJECTIONS FOR SPASTICITY. NEEDLE WAS REPORTED TO BREAK OFF IN "PATIENT MUSCLE", EXACT LOCATION NOT REPORTED. REPORT STATES THAT ACUTE CARE SURGERY WAS CALLED IN TO IDENTIFY THE NEEDLE VIA ULTRASOUND AND WAS ABLE TO EXTRACT THE NEEDLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7608112 ↗
Other Electrode, Needle, Diagnostic Electromyograph devices
- Technomed Europe TE/S50715-001Technomed Engineering B.V. · Electrode, Needle, Diagnostic Electromyograph1 recall2 reports
- Technomed Europe TE/S46-638Technomed Engineering B.V. · Electrode, Needle, Diagnostic Electromyograph1 recall2 reports
- Technomed Europe TE/S50715-001-CTechnomed Engineering B.V. · Electrode, Needle, Diagnostic Electromyograph1 recall0 reports
- Technomed Europe TE/S50715-004Technomed Engineering B.V. · Electrode, Needle, Diagnostic Electromyograph1 recall0 reports
- N/A 8227410Medtronic Xomed, Inc. · Electrode, needle, diagnostic electromyograph12 reports
- Teca Elite S53153Natus Manufacturing Limited · Electrode, Needle, Diagnostic Electromyograph7 reports
- Dantec 9013S0032Natus Manufacturing Limited · Electrode, Needle, Diagnostic Electromyograph6 reports
- Dantec 9013S0042Natus Manufacturing Limited · Electrode, Needle, Diagnostic Electromyograph4 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 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