PulseRider Aneurysm Neck Reconstruction Device 311-DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00859030005093), received between Feb 13, 2018 and Mar 8, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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.

• InjuryMar 8, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  AS REPORTED BY A HEALTH CARE PROFESSION, DURING AN 8MM BASILIAR TIP COIL EMBOLIZATION, THE PHYSICIAN DELIVERED A PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (201D, W2554-19), TO DEPLOYMENT SITE AND SUCCESSFULLY DEPLOYED THE PULSERIDER IN BIFURCATION WITH LEFT ARCH PEDAL INTRA ANEURYSMAL AND RIGHT ARCH PEDAL IN RIGHT POSTERIOR CEREBRAL ARTERY (PCA). THE PHYSICIAN DID NOT LIKE THE APPEARANCE OF THE RIGHT ARCH PEDAL WALL POSITION AND SUCCESSFUL. THE PULSERIDER WAS REMOVED. ANOTHER PULSERIDER (311D, W2557-06) WAS INTRODUCED AND SUCCESSFULLY DEPLOYED INTRA ANEURYSMAL. AN 8X24 GALAXY G2 COILS WERE INTRODUCED TO THE ANEURYSM THRU AN SL10 MICROCATHETER. THE G2 COIL WAS MANIPULATED SEVERAL TIMES AND THE PHYSICIAN WAS NOT PLEASED WITH AN APPEARANCE THE COIL WAS PROTRUDING INTO THE PARENT ARTERY. HE DID NOT BELIEVE THE PULSERIDER WAS ADEQUATELY PROVIDING ENOUGH NECK COVERAGE TO SUCCESSFULLY KEEP THE COILS IN THE ANEURYSM AND THEN SUCCESSFULLY RE-SHEATHED THE PULSERIDER AND PROCEEDED TO ANOTHER TREATMENT MODALITY. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICES WERE DISCARDED, THEREFORE, ARE NOT AVAILABLE FOR INVESTIGATION.

  Patient problems: No Code Available

  MAUDE report 7323004 ↗
• InjuryFeb 13, 2018Retraction Problem; Retraction Problem

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, AFTER MULTIPLE ATTEMPTS TO ¿LAND¿ THE PULSERIDER (311D, W3092-01) INTRASACCULAR, THE DECISION WAS MADE TO REMOVE THE PULSERIDER AND THE .021 PROWLER SELECT PLUS TOGETHER. SOMEHOW, THE PROWLER SELECT PLUS ¿WRAPPED¿ AROUND THE MEDTRONIC PHENOM .017 MICROCATHETER. BOTH MICROCATHETERS WERE REMOVED FROM PATIENT. BOTH PULSERIDER AND THE MICRO CATHETERS WERE REPLACED WITH NEW DEVICES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7265998 ↗