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MICROWIRE DEPTHALON®
PMT CORPORATION · Model 2104-10-16-004 · UDI-DI 00650551003199
GZL
Prescription
10
510(k) clearances
227
Adverse events (3 deaths)
24
Recalls
24
Facilities
Description
MICROWIRE DEPTHALON ELECTRODE, 2MM CONTACTS MARCO CONTACT DIA., 10 MACRO CONTACTS, 16 MICROWIRE CONTACTS, MINI CONNECTOR, 47MM RECORDING LENGTH
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-09-19 | Ad-Tech Medical Instrument Corporation | Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly p |
| 2024-09-19 | Ad-Tech Medical Instrument Corporation | Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly p |
| 2024-09-19 | Ad-Tech Medical Instrument Corporation | Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly p |
| 2021-12-09 | DIXI MEDICAL USA | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| 2021-12-09 | DIXI MEDICAL USA | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| 2021-12-09 | DIXI MEDICAL USA | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| 2021-12-09 | DIXI MEDICAL USA | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| 2021-12-09 | DIXI MEDICAL USA | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| 2021-12-09 | DIXI MEDICAL USA | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| 2021-12-09 | DIXI MEDICAL USA | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.