RED 43 RED43138-ARecalls & reported problems
Penumbra, Inc. · Reperfusion Catheter RED 43, 138cm, no CE · Class 2
Data updated Oct 16, 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 00815948025738), received between May 23, 2025 and May 23, 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
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.
MalfunctionMay 23, 2025Fracture; Fracture
THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERIOR M2 BRANCH OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), A GUIDEWIRE, AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, SUCCESSFUL PASSES WERE MADE WITH THE RED43 IN THE TARGET LOCATION. THE RED43 WAS REMOVED FROM THE PATIENT. THE PHYSICIAN NOTICED A SHINY OBJECT IN THE CLOT ON THE TABLE AND LOOKED AT THE RED43 AND NOTED THE DISTAL TIP TO BE FRACTURED. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22077298 ↗
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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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