MIDWAY 62MWAY115-ARecalls & reported problems
Penumbra, Inc. · MIDWAY 62 Delivery Catheter, 115cm, 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 00815948028197), received between Jun 25, 2024 and Jun 25, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash1
- Material Deformation1
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 25, 2024Leak/Splash; Material Deformation; Leak/Splash; Material Deformation
THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A MIDWAY 62 DELIVERY CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE MIDWAY 62 DELIVERY CATHETER TO THE TARGET LOCATION TO PERFORM A CONTRAST RUN. WHILE ATTEMPTING TO INJECT CONTRAST THROUGH THE MIDWAY 62 DELIVERY CATHETER, THE PHYSICIAN NOTICED THAT THE MIDWAY 62 DELIVERY CATHETER WAS LEAKING CONTRAST FROM A KINK ON THE STRAIN RELIEF. THEREFORE, THE MIDWAY 62 DELIVERY CATHETER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA ACCESS CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19608734 ↗
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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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