WayPoint™ Surgical Kit 66-WP-SKS-00304Recalls & reported problems
Fhc, Inc. · WayPoint Disposable Surgical Kit, sterile · 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 00873263003046), received between Mar 31, 2025 and Mar 31, 2025 — classified as 1 injury.
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
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Post Operative Wound Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON 3/1 DR. (B)(6) INFORMED FHC REP. ABOUT A POSSIBLE FIDUCIAL INFECTION IN THE PATIENT (B)(6) (SN (B)(6)) DURING THE DBS PROCEDURE ON 2/27. HE SAID IT WAS THE ANTERIOR-RIGHT FIDUCIAL. HE WASN'T SURE IF IT WAS REALLY AN INFECTION OR FAT NECROSIS. THEY DIDN'T CULTURE IT, BUT PROCEEDED AS IF IT WAS AN INFECTION BY REMOVING THE FIDUCIAL AND CLEANING THE COMPROMISED AREA AND ISOLATING IT SO THE CASE DIDN'T CANCEL. DR. (B)(6) CONFIRMED THE PLATFORM WAS STABLE AND THE CASE WAS COMPLETED SUCCESSFULLY. PATIENT WILL COME BACK THE FOLLOWING WEEK TO GET THE IPG GENERATOR IMPLANTED. ON 3/18 FHC REACHED OUT TO DR. (B)(6) TO FOLLOW UP ON ANY UPDATES FROM THIS PATIENT AFTER HIS VISIT TO GET THE GENERATOR. DR. (B)(6) REPLIED AND SAID "SO FAR, NO ISSUES. HE CAME BACK FOR HIS SECOND STAGE PROCEDURE AND EVERYTHING LOOKED LIKE IT WAS HEALING APPROPRIATELY. WE WILL SEE HIM NEXT IN NEUROSURGERY IN A COUPLE OF MONTHS". THERE WAS NO INDICATION OF LARGER HARM TO THE PATIENT. THERE WAS NO INDICATION OF ANY FAILURE OR DEFECT OF THE ANCHOR SCREW (FIDUCIAL). PRODUCT WAS DISCARDED.
Patient problems: Post Operative Wound Infection
MAUDE report 21734311 ↗
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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.
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