Millipede 088 Access Catheter 2.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05391539370142), received between Dec 5, 2024 and Dec 5, 2024 — classified as 1 injury.

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WITH A NIHSS SCORE OF 17 AND BASELINE MTICI SCORE OF 0 WAS TREATED FOR A LEFT MIDDLE CEREBRAL ARTERY OCCLUSION. A THIRD PARTY 8F SHEATH WAS USED FOR ACCESS. THE MILLIPEDE 088 CATHETER WAS NAVIGATED OVER A MILLIPEDE 070 CATHETER. THE MILLIPEDE CATHETERS WERE NAVIGATED OVER A THIRD PARTY MICROCATHETER AND GUIDEWIRE. IT WAS RECORDED THAT THE CLOT WAS CROSSED WITH THE THIRD PARTY MICROCATHETER AND GUIDEWIRE DURING EACH PASS. AFTER 3 PASSES, IT WAS NOTED THAT THERE WAS EMBOLIZATION OF CLOT TO THE LEFT ANTERIOR CEREBRAL ARTERY. A THIRD PARTY STENTRIEVER WAS USED IN COMBINATION WITH ASPIRATION FOR TWO SUBSEQUENT PASSES, BUT THE EMBOLUS COULD NOT BE RETRIEVED. THE FINAL MTICI SCORE AT THE END OF THE PROCEDURE WAS 2B. FOLLOWING THE PROCEDURE, THE PATIENT RAPIDLY DETERIORATED AND THE PATIENT'S FAMILY DECLINED FURTHER CONTINUANCE OF CARE. THE PATIENT DIED 5 DAYS AFTER THE PROCEDURE. THE TREATING PHYSICIAN ATTRIBUTED THE DEATH TO THE SEVERITY OF THE STROKE AND THE PATIENT'S AGE. ACCORDING TO THE PHYSICIAN, THE STROKE WAS RAPIDLY EVOLVING TO A LARGER ISCHEMIC STROKE WHICH LED TO EARLY NEUROLOGICAL DETERIORATION DESPITE ARTERIAL RECANALIZATION.

  Patient problems: Thromboembolism

  MAUDE report 20851300 ↗