Penumbra System 5MAXACE068-ARecalls & reported problems
Penumbra, Inc. · 5MAXACE068-A · Class 2
Data updated Oct 13, 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 00814548016580), received between Feb 10, 2017 and Feb 10, 2017 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
- Device Damaged Prior to Use1
- Out-Of-Box Failure1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 10, 2017Break; Device Damaged Prior to Use; Out-Of-Box Failure; Break; Device Damaged Prior to Use; Out-Of-Box Failure
DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE HUB OF THE PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE 68) WAS BROKEN UPON REMOVAL FROM THE PACKAGING. THE DAMAGED ACE 68 WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE 68.
Patient problems: No Patient Involvement
MAUDE report 6324380 ↗
Other CATHETER, THROMBUS RETRIEVER devices
- Penumbra System 5MAXJET7KIT-BPenumbra, Inc. · Catheter, Thrombus Retriever1 recall14 deaths221 reports
- Penumbra System 3MAXCPenumbra, Inc. · CATHETER, THROMBUS RETRIEVER1 death241 reports
- EMBOTRAP ET309537Neuravi Limited · Catheter, Thrombus Retriever13 deaths177 reports
- ACE 5MAXACE068KITPenumbra, Inc. · CATHETER, THROMBUS RETRIEVER170 reports
- Embotrap ET009533Neuravi Limited · Catheter, Thrombus Retriever16 deaths153 reports
- Penumbra System 5MAXACE132Penumbra, Inc. · CATHETER, THROMBUS RETRIEVER3 deaths112 reports
- Penumbra System 5MAXJET7KIT-APenumbra, Inc. · Catheter, Thrombus Retriever1 death94 reports
- Trevo XP 90185Stryker Corporation · CATHETER, THROMBUS RETRIEVER1 recall1 death40 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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