PROWATERflex AGH147000Recalls & reported problems
Asahi Intecc CO., Ltd. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 2
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04547327056311), received between Sep 16, 2024 and Mar 10, 2025 — classified as 2 deaths, 1 injury.
The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Separation2
- Material Fragmentation1
Patient problems
- Foreign Body In Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
DeathMar 10, 2025Material Separation; Material Separation
IT WAS REPORTED THAT AN ASAHI PROWATERFLEX GUIDE WIRE WAS FRACTURED IN THE LEFT MAIN TRUNK (LMT) DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT THE SEGMENT FROM THE LMT TO THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE WIRE FRAGMENT WAS LEFT IN SITU. IT WAS INFORMED THAT THE PATIENT EVENTUALLY DIED.
Patient problems: Foreign Body In Patient
MAUDE report 21569061 ↗DeathMar 7, 2025Material Fragmentation; Material Fragmentation
DETAILS TO FOLLOW AS OUR SALES REP WILL BE ONSITE ON (B)(6) 2025. AT THIS MOMENT, ALL HE KNOWS IS THAT THE TIP OF THE PROWATER BROKE OFF IN THE LEFT MAIN AND PATIENT ENDED UP DYING. HE WILL GATHER MORE INFORMATION ABOUT LESION AND OTHER DEVICES USED WHEN HE PICKS UP THE WIRE.
Patient problems: Foreign Body In Patient
MAUDE report 21554263 ↗InjurySep 16, 2024Material Separation; Material Separation
IT WAS REPORTED THAT AN ASAHI PRO-WATER FLEX GUIDE WIRE WAS FRACTURED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI). THE WIRE FRAGMENT WAS RETRIEVED WITH AN UNSPECIFIED SNARE. THE PHYSICIAN COMMENTED THAT THE WIRE FRACTURE COULD BE LIKELY ATTRIBUTED TO AN UNSPECIFIED STENT THAT HAD BEEN DEPLOYED IN THE VESSEL. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20233650 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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