Guidewire 0.018 4/220cm angled (Straub Medical®) Version 1.0Recalls & 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07640142810247), received between Jan 7, 2021 and Jan 23, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (3 reports).
1 other recall cover devices cleared under the same FDA submission (K172315, K211738); they may or may not involve this specific model.
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
- Break3
- Detachment of Device or Device Component1
- Fracture1
- Insufficient Device Problem Information1
Patient problems
- Foreign Body In Patient2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 23, 2026Break; Detachment of Device or Device Component
ON (B)(6) 2025, AN 88-YEAR-OLD PATIENT UNDERWENT A THROMBECTOMY AND ATHERECTOMY PROCEDURE USING AN ASPIREX DEVICE. DURING THE PROCEDURE, IT WAS NOTICED THAT THE GUIDE PROVIDED IN THE KIT WAS BROKEN. IT WAS RETRIEVED BY LASSO. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 24159899 ↗MalfunctionFeb 11, 2021Fracture; Break; Fracture
DOCTOR WAS PERFORMING A MECHANICAL THROMBECTOMY IN A AV FISTULA USING ROTAREX. ROTAREX WAS RAN FOR LESS THAN 1 MINUTE WHEN PATIENT STATED HE WAS FEELING PAIN. UPON INSPECTION UNDER FLUOROSCOPY, IT WAS NOTICED THAT THE WIRE HAD BROKEN OFF. DOCTOR RETRIEVED THE BROKEN END WITH NO PHYSICAL DAMAGE TO PATIENT. PATIENT RETURNED TO POST OP IN GOOD CONDITION. DOCTOR WAS HAPPY WITH THE RESULTS. COMPLAINED IS GUIDEWIRE GW 0.018" 4/220 CM WHICH IS PART OF SET ROTAREXS 8F 85CM. FURTHER INFORMATION ABOUT SET ROTAREXS 8F 85CM: CATALOGUE NUMBER: 80238, LOT NUMBER: 200137, EXPIRATION DATE (MM/DD/YYY): 01/11/2023, UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions; Pain
MAUDE report 11314703 ↗InjuryJan 7, 2021Break; Insufficient Device Problem Information; Insufficient Device Problem Information
FURTHER INFORMATION ABOUT SET ROTAREXS 8F 85CM: CATALOGUE NUMBER: 80238, LOT NUMBER: 200137, EXPIRATION DATE (MM/DD/YYY): 01/11/2023, UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4).
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 11134937 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K172315, K211738. One submission often covers many models, so check the product and lot details in each record.
- Z-1244-2025 · Feb 5, 2025 · Open, ClassifiedRotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239
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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