MIDWAY 62MWAY125-ARecalls & reported problems
Penumbra, Inc. · MIDWAY 62 Delivery Catheter, 125cm, no CE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815948028036), received between Jun 24, 2025 and Jun 24, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Stretched1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 24, 2025Fracture; Stretched; Fracture; Stretched
THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A MIDWAY 62 DELIVERY CATHETER (MIDWAY 62), A NON-PENUMBRA GUIDE CATHETER, A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. IT WAS REPORTED THAT THE SIGMOID SINUS WAS TORTUOUS AND STENOSED. DURING THE PROCEDURE, THE PHYSICIAN OBTAINED BILATERAL FEMORAL ACCESS VIA LEFT AND RIGHT FEMORAL VEIN WITH 8F SHEATHS. OPERATING THROUGH R FEMORAL ACCESS, IT WAS REPORTED THAT THE GUIDE CATHETER WAS OVALIZED AND KINKED WHEN ADVANCED THROUGH THE SIGMOID SINUS. A MIDWAY 62 WAS THEN ADVANCED THROUGH THE DAMAGED GUIDE CATHETER TO PROVIDE ADDITIONAL SUPPORT ALONG WITH A GUIDEWIRE. WHILE ATTEMPTING TO REMOVE THE MIDWAY 62, IT STRETCHED AND FRACTURED. THE PHYSICIAN EXCHANGED THE 8F SHEATH VIA THE RIGHT FEMORAL VEIN FOR A LONGER 8F SHEATH. THE LONGER 8F SHEATH WAS ADVANCED TO THE RIGHT INTERNAL JUGULAR TO PROVIDE SUPPORT TO THE GUIDE CATHETER. ATTEMPTS TO SNARE THE MIDWAY 62 WERE UNSUCCESSFUL SO THE SYSTEM WAS RETRACTED FOR REMOVAL. UPON RETRACTION, THE DISTAL FRACTURED MIDWAY 62 SEGMENT WAS RETRIEVED BUT THE GUIDE CATHETER FRACTURED. THE PHYSICIAN UPSIZED TO A 12F SHEATH IN THE LEFT FEMORAL VEIN ACCESS. AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12) WAS ADVAN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22324634 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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