DORO® Easy-Connect Navigation Adaptor 1204.002Recalls & reported problems
Black Forest Medical GmbH · DORO® Easy-Connect Navigation Adaptor, BRAINLAB · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04250435506738), received between Mar 14, 2025 and Mar 14, 2025 — classified as 1 malfunction.
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (K001808); they may or may not involve this specific model.
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.
Reports received per month
Recalls naming this device
- Mar 14, 2025Class IIOpen, Classified
Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation system cannot be excluded.
Z-1860-2025 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 14, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
DURING A COMPARISON OF THE DRAWINGS OF THE PRODUCTS 1204.002 DORO® EASY-CONNECT NAVIGATION ADAPTER, BRAINLAB AND 41725 STANDARD CRANIAL REFERENCE ARRAY, IT WAS DETERMINED THAT IN CERTAIN INSTANCES THE COMPATIBILITY OF BOTH DEVICES MIGHT BE COMPROMISED. THIS MIGHT HAVE AN INFLUENCE ON THE POSITIONING OF THE REFERENCE ARRAY. DUE TO THAT AN INFLUENCE OF THE FUNCTION OF THE NAVIGATION SYSTEM CANNOT BE EXCLUDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21607462 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K001808. One submission often covers many models, so check the product and lot details in each record.
- Z-0193-2018 · Nov 2, 2017 · Terminatedpmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY The DORO(R) Skull Pins are inserted into t
Other Holder, Head, Neurosurgical (Skull Clamp) devices
- MAYFIELD® A1059Integra Lifesciences Corporation · HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)506 reports
- MAYFIELD® A3059Integra Lifesciences Corporation · HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)196 reports
- DORO® Skull Clamp 1001.001Black Forest Medical GmbH · Holder, Head, Neurosurgical (Skull Clamp)173 reports
- Head Fixation Device HFD100IMRIS Imaging, Inc. · Holder, Head, Neurosurgical (Skull Clamp)1 recall13 reports
- HFD100 119629-000IMRIS Imaging, Inc. · Holder, Head, Neurosurgical (Skull Clamp)1 recall6 reports
- DORO® Skull Clamp 3003-009Black Forest Medical GmbH · Holder, Head, Neurosurgical (Skull Clamp)52 reports
- HFD100 119695-000IMRIS Imaging, Inc. · Holder, Head, Neurosurgical (Skull Clamp)1 recall1 report
- HFD100 119630-000IMRIS Imaging, Inc. · Holder, Head, Neurosurgical (Skull Clamp)1 recall0 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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