PulseRider Aneurysm Neck Reconstruction Device 213-DRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00859030005123), received between Dec 7, 2021 and Oct 16, 2023 — classified as 7 injuries, 2 malfunctions.

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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2023Migration; Migration

  AS REPORTED BY THE FIELD, DURING A COILING PROCEDURE OF BASILAR ARTERY (BA-TOP) ANEURYSM WITH A PULSERIDER T, 4MM, 10MM ARCH (213D, 3077440609) SUCCESSFUL IMPLANTATION ON (B)(6) 2023. DURING THE PROCEDURE, A 5FR FUBUKI DILATOR WAS PLACED AND VECTA71 INTERMEDIATE CATHETER, PROWLER SELECT PLUS MICROCATHETER (UNKNOWN PRODUCT CODE/LOT NUMBER), HEADWAY17 MICROCATHETER WAS INSERTED. THE PULSERIDER WAS IMPLANTED THROUGH PROWLER SELECT PLUS, THEN COILING WAS CONDUCTED. AFTER THE COILING, DETACHMENT WAS CONFIRMED. NO ABNORMALITIES WERE FOUND ON ONE MONTH FOLLOW UP. ON THE FOLLOW UP ANGIOGRAPHY IN (B)(6), SUSPECTED MINOR MIGRATION OF THE PULSERIDER WAS NOTED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE DURING THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 04-OCT-2023 INDICATED THAT THE PULSERIDER'S LEAFLET SLIPPED FROM THE ANEURYSM NECK, TOWARD THE BASILAR ARTERY. NO ISCHEMIC-HEMORRHAGIC COMPLICATIONS OCCURRED. SLIGHT COMPACTION WAS FOUND ON THE COIL MASS. THE PHYSICIAN IS PLANNING TO SHARE DIAGNOSTIC IMAGES, AND FUTURE PLAN HOW TO TREAT THE ISSUE WILL BE DISCUSSED. ADDITIONAL INFORMATION RECEIVED ON 12-OCT-2023 INDICATED THAT A SLIGHT COMPACTION WAS CONFIRMED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17940299 ↗
• InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TO TREAT A RECURRENT BASILAR ARTERY ANEURYSM, AFTER PREPARATION OF THE DEVICES, THE PROCEDURE WAS INITIATED. THE COMPLAINT DEVICE, A PULSERIDER 10T, 3.5 ¿ 4.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (213D / LOT# UNKNOWN) WAS PLACED VIA A PROWLER SELECT PLUS MICROCATHETER (CATALOG / LOT# UNKNOWN) AND TWO (2) COMPETITOR COILS WERE IMPLANTED. CONTINUOUS FLUSH WAS MAINTAINED. IT WAS REPORTED THAT THROMBUS WAS OBSERVED AND MEDICATION WAS ADMINISTERED. THROMBUS REDUCTION WAS CONFIRMED, AND THE PULSERIDER ANRD WAS WITHDRAWN. IT WAS REPORTED THAT PROCEDURE WAS COMPLETED. PATIENT IMPACT WAS REPORTED AS UNKNOWN AT THE TIME OF THE COMPLAINT INITIATION. ON 03-JUL-2023, ADDITIONAL INFORMATION WAS RECEIVED. PER THE ADDITIONAL INFORMATION, THE LOT NUMBER OF THE PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) IS 3079596004. THE INFORMATION INDICATED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITHOUT ANY ADDITIONAL THROMBUS GENERATED.

  Patient problems: Thromboembolism

  MAUDE report 17322396 ↗
• InjuryMar 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT ON (B)(6) 2023, DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE WITH THE TARGET AT THE BASILAR ARTERY (BA) TIP, THE COMPLAINT DEVICE, A PULSERIDER, 3.5-4.5MM, 10MM, T SHAPE (213D / LOT#: UNKNOWN) WAS IMPLANTED VIA A PROWLER SELECT PLUS MICROCATHETER (CATALOG / LOT#: UNKNOWN) WITH CONTINUOUS FLUSH MAINTAINED. THE PROCEDURE WAS COMPLETED. IT WAS THEN REPORTED THAT ¿AFTER HEPARIN WAS CUT, THROMBOSIS WAS CONFIRMED PAST 3 TO 4 DAYS AFTER THE PROCEDURE. THE PATIENT WAS BEING MONITORED WITH MEDICAL TREATMENT, BUT AROUND ON (B)(6) 2023, IT WAS FOUND OUT THAT IT WOULD BE BETTER TO PERFORM AN ADDITIONAL PROCEDURE, AND AN ATLAS STENT WAS ADDITIONALLY PLACED. THE PATIENT HAS BEEN STABLE AFTER IMPLANTATION OF THE ATLAS STENT.¿ THE PATIENT WAS REPORTED TO HAVE BEEN HOSPITALIZED; THE THROMBOSIS HAS BEEN STABLE. NO ADDITIONAL MEDICAL TREATMENT WILL BE PERFORMED. ON 27-FEB-2023, THE JAPAN TEAM TRANSLATED THE MEMO THAT WAS INCLUDED IN THE COMPLAINT. A SUMMARY OF THE MEMOS IS BELOW: THE FIRST MEMO (MEMO 1). IN THE ANTERIOR CIRCULATION, A FLEXOR® SHUTTLE® 7FR GUIDING SHEATH (COOK MEDICAL), TWO (2) TACTICS MICROCATHETERS (TECHNOCRAT CORPORATION), AND DISTAL ACCES

  Patient problems: Thromboembolism

  MAUDE report 16537793 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA A POST-MARKET STUDY (PMS), THE 46-YEAR-OLD PATIENT UNDERWENT A PULSERIDER-ASSISTED ENDOVASCULAR COIL EMBOLIZATION PROCEDURE TARGETING A RUPTURED (NON-ACUTE) ANEURYSM AT THE BASILAR ARTERY (BA) BIFURCATION USING A PULSERIDER T SHAPE, 10MM, 3.5 ¿ 4.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (213D / LOT# UNKNOWN) ON (B)(6) 2022. THE DIMENSIONS OF THE TARGET ANEURYSM ARE AS FOLLOWS: HEIGHT 4.6MM, MAXIMUM ANEURYSM DIAMETER 5.9MM, DOME WIDTH 4.7MM, NECK DIAMETER 5.5MM, DOME TO NECK RATIO 0.9. THE PARENT VESSEL DIAMETER WAS 3.2MM, THE (2) BRANCHING VESSEL DIAMETER WAS 3.0MM AND (3) BRANCHING VESSEL DIAMETER WAS 2.5MM. THE PULSERIDER ANRD WAS DELIVERED VIA A PROWLER SELECT PLUS MICROCATHETER (CATALOG / LOT# UNKNOWN) AND SUCCESSFULLY IMPLANTED OUTSIDE THE ANEURYSM. THE COIL MASS WAS SUCCESSFULLY MAINTAINED AND THE PROCEDURE WAS COMPLETED. IT WAS NOT KNOWN IF A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. ON THE SAME DAY, IT WAS REPORTED THAT THE PATIENT SUFFERED A CEREBRAL INFARCTION IPSILATERAL TO THE TARGET ANEURYSM. EDARAVONE WAS ADMINISTERED. ON 12-MAR-2022, IT WAS REPORTED THAT THE PATIENT WAS CONFIRMED TO BE RECOVERING. THE TREATING PHYSICI

  Patient problems: Ischemia Stroke

  MAUDE report 16419167 ↗
• MalfunctionFeb 22, 2023Material Separation; Material Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TO TREAT COMPACTION AT THE ANEURYSM ON THE BASILAR ARTERY (BA), A PULSERIDER T SHAPE, 8MM , 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (201D / LOT# UNKNOWN) WAS USED. IT WAS DELIVERED VIA A PROWLER SELECT PLUS MICROCATHETER (CATALOG / LOT# UNKNOWN) TO THE TARGET LESION AND THE PULSERIDER ANRD WAS IMPLANTED. IT WAS REPORTED THAT CONTINUOUS FLUSH WAS MAINTAINED. COILS (UNSPECIFIED BRANDS) WERE IMPLANTED. AFTER THE IMPLANTATION OF THE COILS, THE PULSERIDER ANRD WAS DETACHED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. IT WAS REPORTED THAT THE PATIENT HAD NO SUBJECTIVE SYMPTOMS. POST-OPERATIVE MAGNETIC RESONANCE IMAGING (MRI) REVEALED METAL FRAGMENT ARTIFACT; THE PHYSICIAN COMMENTED THAT THE FRAGMENT MIGHT BE ATTRIBUTABLE TO THE COMPLAINT PULSERIDER ANRD. ON 17-FEB-2023, THE CERENOVUS SALES REPRESENTATIVE PROVIDED A POWER POINT SLIDE PRESENTATION OF IMAGES FROM THE PROCEDURE. THE PRESENTATION IS PENDING INDEPENDENT PHYSICIAN REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16418938 ↗
• InjuryOct 11, 2022Break; Retraction Problem; Failure to Advance; Break; Retraction Problem; Failure to Advance

  IT WAS REPORTED FROM A PERSONAL INTERACTION THAT A PATIENT UNDERWENT AN ENDOVASCULAR EMBOLIZATION PROCEDURE FOR AN ANEURYSM IN THE INTERNAL CAROTID ARTERY. PER EVENT DESCRIPTION, THE 4MM X 10MM PULSERIDER T-ARCH (213D/ 3077440602) ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) WAS DELIVERED USING A GUIDEPOST INTERMEDIATE CATHETER AND A PROWLER SELECT PLUS MICROCATHETER. IT WAS REPORTED THAT THE PULSERIDER WAS IMPLANTED BUT NOT DETACHED. THE PHYSICIAN THEN STARTED WINDING THE FIRST COIL (12X40 TARGET) FROM THE SL-10 MICROCATHETER USING THE TRANSCELL TECHNIQUE. THE COIL LOOP WAS THEN CAUGHT BY THE PULSERIDER; HENCE RESHEATHING THE COIL BECAME DIFFICULT. THE PHYSICIAN ATTEMPTED TO UNTANGLE THE COIL AND PULSERIDER HOWEVER THE LATTER MOVED. AS A RESULT, THE PHYSICIAN DECIDED TO RETRACT THE PULSERIDER AND THE COIL INTO THE GUIDING CATHETER AND WERE REMOVED FROM THE PATIENT¿S BODY. THE PHYSICIAN INSPECTED THE DEVICES, AND IT WAS NOTICED THAT THE PULSERIDER WAS DEFORMED. THE DEVICE WAS NOT REUSED AND DISCARDED. THE PHYSICIAN PROCEEDED WITH THE SURGERY, USING A BALLOON-ASSISTED APPROACH THIS TIME AND THE PROCEDURE WAS COMPLETED. A CONTINUOUS FLUSH WAS PERFORMED DURING THE SURGERY. NO PATIENT IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15580612 ↗
• InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED A PATIENT UNDERWENT PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD)-ASSISTED COIL EMBOLIZATION OF A BASILAR TIP ANEURYSM AND EXPERIENCED THROMBOEMBOLISM DURING THE PROCEDURE. INFORMATION REGARDING CLINICAL SYMPTOMS IS NOT KNOWN. THE TREATING PHYSICIAN COMMENTED THAT SMALL THROMBI WERE ¿FLYING¿ INTO THE PERIPHERY; THE SMALL THROMBI MAY HAVE FLOWN DUE TO THE PULSERIDER DEVICE BEING TAKEN IN AND OUT SEVERAL TIMES DURING PLACEMENT. THE PROCEDURE DETAILS ARE AS FOLLOWING: CONTINUOUS FLUSH WAS MAINTAINED. THE PULSERIDER 10T, 3.5 ¿ 4.5MM ANRD (213D / 3050709712) WAS IMPLANTED VIA A PROWLER SELECT PLUS MICROCATHETER (UNK PRODUCT CODE / UNK LOT NUMBER). AN SL-10® MICROCATHETER (STRYKER) WAS INSERTED INTO THE ANEURYSM VIA TRANSCELL TECHNIQUE AND COIL EMBOLIZATION WAS PERFORMED. THE PULSERIDER ANRD REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Thromboembolism

  MAUDE report 14194333 ↗
• InjuryFeb 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT PULSERIDER-ASSISTED COIL EMBOLIZATION OF AN INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (IC-PC) ANEURYSM ON (B)(6) 2022 AND EXPERIENCED A CEREBRAL INFARCTION ON THE FOLLOWING DAY. THE INFARCT WAS CONFIRMED IN THE PERIPHERY OF THE TERRITORY SUPPLIED BY THE RIGHT MIDDLE CEREBRAL ARTERY (MCA), THE SITE TREATED WITH THE PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD). THE PATIENT ONLY EXPERIENCED A SLIGHT DISCOMFORT IN THE LEFT FOOT AND WAS OTHERWISE ASYMPTOMATIC. THERE WAS NO TREATMENT NOR REOPERATION PERFORMED. THE PATIENT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2022. THE PULSERIDER 10T, 3.5 ¿ 4.5MM ANRD (213D / 3050709708) WAS ALLEGEDLY USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS A CONTINUOUS FLUSH MAINTAINED. THE PULSERIDER WAS DEPLOYED VIA A PROWLER SELECT PLUS MICROCATHETER (UNKNOWN PRODUCT CODE / LOT NUMBER) AND COIL EMBOLIZATION WAS PERFORMED. THE PROCEDURE WAS COMPLETED, AND THE PULSERIDER WAS DETACHED WITHOUT INCIDENT. THE PHYSICIAN COMMENTED THAT THE PULSERIDER WAS MOVED IN AND OUT OF THE MICROCATHETER MULTIPLE TIMES WHEN ADJUSTING THE DEPLOYMENT POSITION. A

  Patient problems: Ischemia Stroke

  MAUDE report 13472690 ↗
• InjuryDec 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A PATIENT UNDERWENT PULSERIDER- ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED BASILAR TIP ANEURYSM AND EXPERIENCED A CEREBRAL INFARCTION DURING THE POST-OPERATIVE PERIOD. THE EXACT TIMING OF THE EVENT IN RELATION TO THE INDEX PROCEDURE WAS NOT REPORTED. HOWEVER, IT WAS STATED THAT THE EVENT WAS NOTED AT THE TIME OF FOLLOW-UP. THE OUTCOME WAS FAVORABLE, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL IN GOOD HEALTH. THE CEREBRAL INFARCTION WAS CLASSIFIED AS MILD IN SEVERITY. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE IMPLANTATION OF A PULSERIDER 10T, 3.5 -4.5MM (213D/3049703304) ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) AND UNSPECIFIED COILS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ischemia Stroke

  MAUDE report 12953813 ↗