Halberd18 PHW18R301SRecalls & reported problems
Asahi Intecc CO., Ltd. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04547327106849), received between Jun 28, 2019 and Jun 28, 2019 — classified as 1 injury.
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 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 28, 2019Break; Break
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SEVERELY CALCIFIED, FLUSH CTO OF THE PROXIMAL LEFT SFA AT THE PROFUNDA. VIA PEDAL ACCESS, A 4 FRENCH SHEATH WAS PLACED AND NON-ASAHI GUIDE WIRE AND CATHETER WERE ADVANCED RETROGRADELY AND TRIED TO BREAK THROUGH THE PROXIMAL CAP OF THE CTO. WHEN THE GUIDE WIRE REACHED THE CAP AND THEN EXCHANGED FOR THE ASAHI GUIDE WIRE. (THE REMOVED NON-ASAHI GUIDE WIRE WAS ALSO ADVANCED VIA THE RIGHT FEMORAL ACCESS WITH A SUPPORT CATHETER.) THE NON-ASAHI CATHETER WAS REPLACED WITH A NON-ASAHI 3.0 X 40MM PTA BALLOON ON THE ASAHI GUIDE WIRE AND BALLOONED THE AREA FOR 5 MIN. AFTER THE DILATATION THE PHYSICIAN ADVANCED THE WIRE AND BALLOON AND THE WIRE APPEARED TO BUCKLE/BEND FORWARD OF THE DISTAL END OF THE BALLOON. EITHER ON THE CALCIFIED CAP OR THE VESSEL MIGHT HAVE GONE INTO SPASM. WHEN HE STARTED TO MOVE THE WIRE BACK AFTER IT BENT, HE NOTICED THAT THE WIRE LOOKED BROKEN AT THE DISTAL TIP AND THAT IT WAS STARTING TO SEPARATE. HE TOOK THE BALLOON OUT OF THE PATIENT AND THEN TOOK A NON-ASAHI CATHETER IN OVER THE ASAHI WIRE COVERING IT COMPLETELY AND HE PULLED THE WIRE AND THE CATHETER AS A UNIT. THE PATIENT TREATMENT WAS COMPLETED SUCCESSFULLY FROM T
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8743202 ↗
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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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