Neuroform Atlas M003SZAS30240Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252656166), received between May 23, 2018 and Dec 12, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Premature Activation” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT AWOKE FROM THE STENT-ASSISTED COIL EMBOLIZATION PROCEDURE INTACT AND HAD STABLE VITALS AND NEUROLOGICAL STATUS UNTIL THE NEUROLOGICAL DETERIORATION ABOUT 10 HOURS POST-PROCEDURE AND COMPUTED TOMOGRAPHY REVEALED MULTIPLE INTRA-COMPARTMENTAL HEMORRHAGES ON RIGHT. SO A RIGHT HEMICRANIECTOMY WAS GIVEN TO THE PATIENT. HOWEVER, THERE WERE NO TECHNICAL DIFFICULTIES AND NO DEVICE MALFUNCTION WAS DETECTED DURING THE PROCEDURE. IN THE PHYSICIAN¿S OPINION, THE RELATIONSHIP BETWEEN THE EVENT AND STENT (SUBJECT DEVICE) WAS UNKNOWN. BECAUSE SUBSEQUENT ANGIOGRAPHY SHOWED THE STENT-COILED ANEURYSM TO BE STABLE WITH STENTS AND NO UNUSUAL ANGIOGRAPHIC FINDINGS TO SUGGEST RELATIONSHIP TO STENT COILING OTHER THAN THE HEMORRHAGE BEING IN THE TERRITORY SUPPLIED BY THE PARENT VESSEL WHICH WAS TREATED.

  Patient problems: Intracranial Hemorrhage; Stroke/CVA

  MAUDE report 8156359 ↗
• MalfunctionMay 23, 2018Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING STENT-ASSISTED COIL EMBOLIZATION OF AN ANEURYSM LOCATED IN THE ANTERIOR COMMUNICATING ARTERY, THE SUBJECT STENT WAS USED WITH A MICROCATHETER IN EXTREMELY TORTUOUS ANATOMY. THE PHYSICIAN TOOK THE MICROCATHETER VERY FAR DISTAL AND PULLED THE SYSTEM BACK TO RELEASE ANY BUILT-UP TENSION. WHEN THE PHYSICIAN BEGAN TO DEPLOY THE SUBJECT STENT, THE MICROCATHETER UNEXPECTEDLY MOVED PROXIMAL TO THE ANEURYSM. THE PHYSICIAN DID NOT FEEL COMFORTABLE TO DEPLOY THE STENT IN THE NEW LOCATION SINCE THE STENT WOULD BE TOO SMALL FOR THE VESSEL SIZE. PARTIALLY DEPLOYED SUBJECT STENT WAS CORKED INTO THE MICROCATHETER AND BOTH THE STENT AND MICROCATHETER WERE SAFELY PULLED BACK AND RETRIEVED SUCCESSFULLY WITHOUT LEAVING DAMAGE TO THE VESSEL. ANOTHER STENT AND MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7539234 ↗