Meister 16 WAMS-180-16STRecalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04547327108317), received between Nov 20, 2025 and Nov 27, 2025 — classified as 1 injury, 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Peeled/Delaminated2
- Flaked1
Patient problems
- Foreign Body In Patient1
- 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.
InjuryNov 27, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT COATING ON AN ASAHI MEISTER 16 GUIDE WIRE CAME OF INSIDE A CONCOMITANTLY USED PROGREAT MICROCATHETER (TERUMO) DURING AN ANGIOGRAPHY FOR A MILDLY CALCIFIED 75% OR LESS STENOSIS WITH MODERATE TORTUOSITY IN THE PROSTATIC ARTERY. THE PEELED COATING WAS NOT COMPLETELY DETACHED AND WAS NOT LEFT IN SITU IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT AND THE PATIENT WAS STABLE WITHOUT ISSUE AFTER THE PROCEDURE.
Patient problems: Foreign Body In Patient
MAUDE report 23663690 ↗MalfunctionNov 20, 2025Flaked; Peeled/Delaminated; Flaked; Peeled/Delaminated
THE COATING FROM THE MEISTER WIRE CAME OFF DURING THE PROCEDURE WHILE INSIDE THE PROGREAT MICRO CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23610474 ↗
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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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