Guidewire 0.025 6/270cm angled 80265Recalls & reported problems
Straub Medical AG · The Rotarex™ S and Aspirex™ S Guidewire has a LubriSkin PTFE-coated nitinol core wire with a gold-plated Tungsten tip. The guidewire is used to initially cross through the area to be treated. To be used with Straub Medical catheters. · 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 07640142811305), received between Jun 1, 2023 and Apr 14, 2024 — 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
- Detachment of Device or Device Component1
- Failure to Advance1
- Material Deformation1
- Peeled/Delaminated1
- Retraction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 14, 2024Break; Detachment of Device or Device Component; Material Deformation; Break; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE VIA THE POPLITEAL VEIN, THE GOLD PART ON THE TIP OF THE WIRE HAD ALLEGEDLY UNRAVELED OFF THE WIRE AND THE WIRE WAS INSIDE THE INFERIOR VENA CAVA OF THE PATIENT. IT WAS FURTHER REPORTER THAT THE PIECE OF GOLD WAS SUCCESSFULLY SNARED OUT OF THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19102882 ↗MalfunctionAug 7, 2023Peeled/Delaminated; Failure to Advance; Peeled/Delaminated; Failure to Advance
IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO ADVANCE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17471219 ↗MalfunctionJun 1, 2023Break; Retraction Problem; Break; Retraction Problem
IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE GUIDEWIRE WAS ALLEGEDLY BROKEN INTO SEGMENTS AND LEFT IN THE VESSEL. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE WAS ALLEGEDLY DIFFICULT TO BE REMOVED AND A SNARE WAS USED TO REMOVE THE WIRE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17036712 ↗
Other Wire, Guide, Catheter devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- 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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