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ClearPoint
Clearpoint Neuro, Inc. · Model CP-MPHFF-122-01 · UDI-DI 00850376007253
HBL
Prescription
1
510(k) clearances
5,826
Adverse events (5 deaths)
14
Recalls
31
Facilities
Description
ClearPoint Siemens Aera / Skyra Multi-Positional HFF
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-08 | IMRIS Imaging Inc | Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alter |
| 2025-03-14 | Pro-Med Instruments Gmbh | 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 |
| 2022-02-17 | Deerfield Imaging, Inc. | Reports have been received that after normal or routine lateral forces are applied to the head fixation device, the split block clamp may deflect (rotationally around the axis) and |
| 2020-11-11 | Integra LifeSciences Corp. | Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram |
| 2019-06-26 | Deerfield Imaging, Inc. | Breaking of the HFD200 Drive Knob force indicator due to over-torqueing of the drive knob beyond the maximum allowable pinning force specification may result in the clinical staff |
| 2018-07-05 | Pro-Med Instruments Gmbh | The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and f |
| 2018-07-05 | Pro-Med Instruments Gmbh | The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and f |
| 2018-07-05 | Pro-Med Instruments Gmbh | The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and f |
| 2017-11-02 | Pro-Med Instruments Gmbh | The firm received reports of two breakages of the pin tips which occurred during two identical surgery procedures. The breakage occurred at the very distal end of the conical part |
| 2017-08-14 | Deerfield Imaging | incorrect thread on thumbscrews |
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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.