pRESET® Delta Thrombectomy Device (6mm x 30mm) PRE2-6-30Recalls & reported problems
Phenox Limited · The pRESET Delta Thrombectomy Device is designed to restore blood flow in the neurovasculature by mechanical removal of thrombus in patients experiencing acute ischemic stroke due to large vessel occlusion with thrombus. The device is designed for use in large vessels of the neurovasculature such as the internal carotid artery (ICA) and middle cerebral artery (MCA). · Class 2
Data updated Oct 18, 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 05391530910460), received between May 27, 2026 and May 27, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Material Separation” (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
- Material Separation1
Patient problems
- Stroke/CVA1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 27, 2026Material Separation
IT WAS REPORTED THAT THE 5X40 WAS DELIVERED TO A M1 CLOT AND UPON RETRIEVAL INTO A SOFIA 88 THE PRESET DETACHED UNINTENTIONALLY, A GOOSE NECK SNARE WAS USED TO TRY TO RECOVER THE STENT BUT DID NOT WORK, ANOTHER 6X30 WAS INTRODUCED TO TRY TO DEPLOY AND RETRIEVE THE 5X40, THAT 6X30 ALSO DETACHED UNINTENTIONALLY. THIS MDR REPORT IS FOR THE PRESET 6X30 DEVICE. AN ADDITIONAL REPORT WILL BE SUBMITTED FOR THE 5X40 DEVICE ADDITIONAL INFO WAS RECEIVED ON 18 MAY 2026: 1. HAS THE PRESET DELTA 6-30 BEEN DISCARDED BY THE HOSPITAL, OR IS IT AVAILABLE FOR RETURN AND ROOT CAUSE ANALYSIS? ONLY THE PUSHERS WERE AVAILABLE AS THEY SEPARATED FROM THE STENT, AND THE STENTS WERE LEFT BEHIND IN THE PATIENT. 2.FOLLOWING THE DETACHMENT OF BOTH PRESET DEVICES, WERE ANY FURTHER ACTIONS TAKEN TO REMOVE THE COMPONENTS FROM THE PATIENT'S ANATOMY? THE FIRST STEP RETRIEVER DETACHED. THAT'S WHEN THE SECOND ONE WAS USED TO TRY AND SNARE AND BRING THE FIRST DEVICE OUT. SUBSEQUENTLY, THE SECOND DEVICE DETACHED. SNATCH WERE USED TO TRY AND LASSO THE DEVICES. BUT NOTHING WAS UNSUCCESSFUL. 3.WHAT WAS THE FINAL OUTCOME OF THE PROCEDURE? AFTER BOTH THE DEVICES DETACH AND WE'RE NOT ABLE TO BE RETRIEVED OR REMOVED. THEY WERE
Patient problems: Stroke/CVA
MAUDE report 25298080 ↗
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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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