SUOH 03 AHW14R013SRecalls & 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 04547327116749), received between May 19, 2021 and Jun 3, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Detachment of Device or Device Component1
- Fracture1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 3, 2021Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT INTERVENTION WAS PERFORMED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) IN THE LEFT CIRCUMFLEX ARTERY (LCX). ANTEGRADE WIRE ESCALATION WAS PERFORMED THROUGH A NON-ASAHI MAMBA CATHETER: FIRST WITH A NON-ASAHI RUNTHROUGH WIRE, A NON-ASAHI FIGHTER WIRE. IT WAS AN AMBIGUOUS CAP. THE PHYSICIAN THEN WENT RETROGRADE DOWN THE APICAL LAD AND USED AN ASAHI SUOH 03 GUIDE WIRE TO ACROSS A HEAVILY TORTUOUS EPICARDIAL COLLATERAL. AS HE WAS ADVANCING AN ASAHI CORSAIR PRO XS MICROCATHETER, THE TIP OF THE GUIDE WIRE BROKE OFF INTO THE COLLATERAL VESSEL. HE WAS ABLE TO SUCCESSFULLY RETRIEVE THE TIP WITH A 4MM MICROSNARE. THE PHYSICIAN COMMENTED THAT THE GUIDE WIRE HAD BEEN PROLAPSED AND KINKED. UPON PULLING IT BACK INTO THE MICROCATHETER, THE MICROCATHETER SHEARED THE COIL OFF OF THE MANDREL OF THE WIRE. ANOTHER SUOH WAS USED AND THE CASE WAS SUCCESSFULLY COMPLETED. THE PATIENT DID GREAT AND EVERYTHING IS FINE. FURTHERMORE, THERE WAS NO ADVERSE REACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11936369 ↗MalfunctionMay 19, 2021Break
AS I KNOW OF RIGHT NOW, DR. (B)(6) WAS USING A SUOH-03 ACROSS AN EPICARDIAL COLLATERAL. I DO NOT KNOW IF IT WAS RCA TO LCA OR VICE-VERSA. APPARENTLY, AS HE WAS ADVANCING A MC (DO NOT KNOW WHICH ONE), THE TIP OF THE SUOH BROKE OFF INTO THE COLLATERAL VESSEL. HE WAS ABLE TO SUCCESSFULLY RETRIEVE THE TIP AND THEY DO HAVE THE WIRE. I AM WAITING ON MORE INFORMATION TO COME BACK FROM KATE MULLER (CCL MANAGER).
Patient problems: Insufficient Information
MAUDE report 11853030 ↗
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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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