PROWATERflex AGH147300Recalls & reported problems
Asahi Intecc CO., Ltd. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04547327056328), received between Apr 23, 2019 and Apr 23, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Peeled/Delaminated” (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 16, 2026.
Most reported problems
Device problems
- Peeled/Delaminated2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 23, 2019Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT AN ASAHI GUIDE WIRE WAS USED FOR A PROCEDURE TO TREAT A CTO IN THE MID RCA WHEN A PORTION OF THE WIRE SHAFT HAD NO COLOR ON IT (POSSIBLE PEELING OF THE PTFE COATING). IT LOCATED OUTSIDE THE GUIDE CATHETER, NOT INSIDE THE PATIENT. THERE WAS NO ISSUE WITH PATIENT OUTCOME RELATED TO THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8542475 ↗InjuryApr 23, 2019Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT AN ASAHI GUIDE WIRE WAS USED FOR ABOUT TWO HOURS IN THE PROCEDURE TO TREAT A CTO IN THE MID RCA. THE PHYSICIAN COMMENTED THAT A PORTION OF THE WIRE SHAFT HAD NO COLOR ON IT WHILE HE DID NOT SEE ANY PAINT COMING OFF. IT WAS ON THE PART OF THE WIRE THAT WAS OUTSIDE A FEW CM PROXIMAL TO THE GUIDE CATHETER, NOT IN THE PATIENT POSSIBLY WHERE A TORQUE DEVICE WAS ATTACHED. REPORTEDLY NO RESIDUE WAS FOUND ON THE DRAPE. THERE WAS NO ISSUE WITH PATIENT OUTCOME RELATED TO THIS EVENT, POSSIBLE PEELING OF THE PTFE COATING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8542473 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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