HYBRID Guidewire HYBRID007JRecalls & reported problems
Balt USA LLC · HYBRID Guidewire is a coiled wire that is designed to fit inside a percutaneous microcatheter for the purpose of directing the catheter through a blood vessel. It is used in association with catheters to enable insertion and easier navigation into the intracranial vascular branches for diagnositc or therapeutic use. Guidewires constitute an important element that conditions the success of the operation. They can be pushed and torqued to move forward through patient's tortuous anatomy. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818053022746), received between Jan 5, 2021 and Nov 17, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
- Inaccurate Information1
- Migration or Expulsion of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 17, 2023Inaccurate Information; Inaccurate Information
IT WAS DISCOVERED DURING ROUTINE INCOMING QUALITY CONTROL INSPECTION ON OCTOBER 16, 2023, THAT THE HYBRID007J LABEL (LB-0047 REV. D) ON LOT 00540774 HAD A LABELLING DISCREPANCY. DIMENSION C DENOTES THE OD OF THE PROXIMAL WIRE, AND HAD IT LISTED AS 0.12" (0.30MM), HOWEVER THE CORRECT SPECIFICATION IS 0.012" (0.30MM).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18165348 ↗MalfunctionFeb 22, 2021Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device
REPORT SENT TO FDA BY USER FACILITY: "WIRE BROKE OFF DURING EMBOLIZATION PROCEDURE AND WAS RETRIEVED. DURING THE PROCEDURE, IT WAS REALIZED THAT THE HYBRID WIRE HAD FRACTURED AND MIGRATED INTO THE LEFT POSTERIOR CEREBRAL ARTERY. THE GUIDEWIRE WAS REMOVED IN ITS ENTIRETY, HEMOSTASIS ACHIEVED. FDA SAFETY REPORT ID # (B)(4)."
Patient problems: Insufficient Information
MAUDE report 11361209 ↗MalfunctionJan 5, 2021Break; Break
IT WAS REPORTED THAT: "THE PHYSICIAN INSERTED THE WIRE IN THE MICROCATHETER AND ADVANCED THE WIRE OUTSIDE THE DISTAL END OF THE MICROCATHETER, THE DISTAL TIP OF THE WIRE WAS SEPARATED FROM THE PROXIMAL END OF THE WIRE. THE TIP OF THE WIRE THEN WAS CARRIED FORWARD BY BLOOD FLOW AND HAD TO BE RETRIEVED WITH A SNARE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11118621 ↗
Other Guide, Wire, Catheter, Neurovasculature devices
- Synchro SELECT SSTD215STRStryker Corporation · Guide, wire, catheter, neurovasculature1 recall97 reports
- Synchro SELECT SSTD215PREStryker Corporation · Guide, wire, catheter, neurovasculature1 recall16 reports
- Synchro SELECT SSUP215PREStryker Corporation · Guide, wire, catheter, neurovasculature1 recall11 reports
- Synchro2 S2SPS14300Stryker Corporation · GUIDE, WIRE, CATHETER, NEUROVASCULATURE1 recall1 death6 reports
- Synchro SELECT SSUP300STRStryker Corporation · Guide, wire, catheter, neurovasculature1 recall5 reports
- Synchro2 S2SPP14300Stryker Corporation · GUIDE, WIRE, CATHETER, NEUROVASCULATURE1 recall2 reports
- Synchro SELECT SSFT300STRStryker Corporation · Guide, wire, catheter, neurovasculature1 recall0 reports
- Mirage 103-0608Micro Therapeutics, Inc. · Guide, wire, catheter, neurovasculature12 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
- 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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