Z-0541-2022Class II

The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode...

Name: Z-0541-2022 The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode...
Creator: Dixi Medical USA
Published: 2021-12-09
License: https://open.fda.gov/license/

Dixi Medical USA / initiated 2021-12-09 / Terminated / root cause: packaging

FDA source

DIXI MEDICAL USA began a recall of The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded... on 2021-12-09. FDA classified it as Class II and gives the reason as "Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0541-2022
Classification: Class II
Status: Terminated
Initiated: 2021-12-09
Posted: 2022-01-28
Terminated: 2023-09-08
Recalling firm: Dixi Medical USA
Product: The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.
Product code: GZL Electrode, Depth
Reason for recall: Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Dixi Medical issued Urgent Medical Device Letter on 12/9/21. Letter states reason for recall, health risk and action to take: 1. Examine your inventory for the affected product. Any available stock must be quarantined immediately and placed in a secure location to prevent further usage. 2. Please use the response form to record and return the stock back to the manufacturer. 3. The returned stock will be replaced with compliant products. 4. Please complete and return the attached Customer Response Form to Ann Cirner, [email protected] (248)845-3494, even if you do not have affected product on hand. 5. Please forward this information to all your staff that may use the MICRODEEP during a SEEG procedure in your healthcare facility. 6. If you have further distributed the product, please forward this notification to any downstream accounts. The removal and return of affected products will be carried out by the hospital staff. Your assistance is appreciated and necessary to prevent a potential patient harm. If you have any questions, call Ann Cirner, [email protected] (248)845-3494
Quantity in commerce: 1792 units
Distribution: US Nationwide distribution.
Product codes and lots: All lots UDI:03664539000176

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0541-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0534-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-09	2022-01-28
Z-0535-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-09	2022-01-28
Z-0536-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-09	2022-01-28
Z-0537-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-09	2022-01-28
Z-0538-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-09	2022-01-28
Z-0539-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-09	2022-01-28
Z-0540-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-09	2022-01-28
Z-0541-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-09	2022-01-28
Z-0542-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-09	2022-01-28

Product code GZL

K170959Class IIDIXI Medical Microdeep Depth ElectrodeDixi Medical / cleared 2017-11-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)