ASAHI Silverway SA0035N26SRecalls & reported problems
Asahi Intecc CO., Ltd. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04547327121620), received between Nov 17, 2021 and Nov 28, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Difficult or Delayed Activation” (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
- Adverse Event Without Identified Device or Use Problem1
- Difficult or Delayed Activation1
- Product Quality Problem1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Pseudoaneurysm1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN ASAHI SILVERWAY DIAGNOSTIC GUIDE WIRE WAS USED TO GAIN ACCESS TO THE RCA/LAD. WHILE ADVANCING THE GUIDE WIRE VIA THE LEFT RADIAL ARTERY, IT UNINTENTIONALLY ENTERED INTO THE THYROCERVICAL BRANCH OR DISSECTION PLANE AND DEVELOPED A PSEUDOANEURYSM (PSA). COIL EMBOLIZATION WAS PERFORMED TO TREAT THE PSA. THE PATIENT WAS FINE; HOWEVER, THIS RESULTED IN A WEEK DELAY OF A CORONARY ARTERY BYPASS GRAFTING (CABG).
Patient problems: Pseudoaneurysm
MAUDE report 12880083 ↗MalfunctionNov 17, 2021Product Quality Problem; Use of Device Problem; Difficult or Delayed Activation
SPECIFIC FEEDBACK ON THE TWO ISSUES: THE SILVERWAY ENTERED THE THYROCERVICAL BRANCH WITH LEFT RADIAL ARTERIAL ACCESS. PSA. HAD TO COIL EMBOLIZE. DELAYED CABG. THE SILVERWAY WIRE EXITED INTO BRANCH OR DISSECTION PLANE RESULTING IN DELAY OF PROCEDURE. GENERAL FEEDBACK ON THE WIRE: WIRE IS HARDER TO CONTROL. ALMOST TOO LUBRICIOUS. LACKS ADEQUATE TACTILE FEEDBACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12829562 ↗
Other Wire, guide, catheter devices
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- 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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