Approach Authority Workhorse Microwire Guide AUTH-18-300Recalls & reported problems
Heraeus Medical Components LLC · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816840020777), received between Nov 2, 2021 and Nov 2, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
A (B)(6) MALE PATIENT UNDERWENT AN INTERVENTION SFA CTO IN WHICH THE APPROACH AUTHORITY WORKHORSE MICROWIRE GUIDE, ,018 WIRE DIAMETER, 300CM LENGTH, 6.5CM POLYMER LENGTH, 8CM TAPER LENGTH, G57804, WAS USED. TIBIAL ACCESS, ATTEMPTING TO CROSS CALCIFIED CTO OF SFA WITH AUTHORITY WIRE THROUGH 018 ANGLED CXI. PROLAPSED TIP TRYING TO PUSH THROUGH CTO, WIRE AND CATHETER ENTERED SUBINTIMAL SPACE. AFTER A LITTLE BIT OF MANEUVERING A PORTION OF THE TIP OF THE WIRE BROKE. DISTAL TIP OF THE WIRE BROKE OFF AND WEDGED INTO THE SUBINTIMAL SPACE, MD [THE PHYSICIAN] DECIDED TO LEAVE BROKEN TIP AND NOT TRY TO RETRIEVE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 12736325 ↗
Other Wire, Guide, Catheter devices
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- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 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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