EMBOSHIELD NAV6 22438-19Recalls & reported problems

Summary

The FDA's MAUDE database contains 348 adverse event reports that list this exact device (DI 08717648137754), received between Aug 17, 2016 and Sep 29, 2026 — classified as 1 death, 140 injuries, 207 malfunctions.

The most frequently reported specific device problem is “Material Separation” (97 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 348 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Difficult to Remove; Material Separation

  It was reported that the procedure was performed in the right common carotid artery. The Emboshield Nav 6 filter got caught on an implanted non-Abbott stent upon retrieval and separated. The filter had to be removed using an aspirator catheter, ending the procedure. The patient was then discharged. There was no clinically significant delay in the procedure. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927311 ↗
• MalfunctionAug 25, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50433110 ↗
• MalfunctionAug 12, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50229309 ↗
• InjuryAug 4, 2026Retraction Problem; Material Split, Cut or Torn

  It was reported the procedure was to treat a mildly calcified and tortuous lesion in the Internal carotid artery. The NAV6 Embolic Protection System (EPS) was advanced to the target lesion and the filter deployed. After stent deployment was completed, during retrieval of the embolic protection filter, the tip of the retrieval catheter became entangled with a stent strut, preventing normal retrieval. Repeated advancement attempts resulted in tearing of the retrieval catheter tip. The retrieval catheter was subsequently withdrawn, and the delivery catheter was used to successfully retrieve the filter. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50127585 ↗
• InjuryJul 27, 2026Retraction Problem; Material Separation

  It was reported that the procedure was to treat a stenosed lesion in the internal carotid artery (ICA). The large Emboshield Nav 6 embolic protection system (EPS) was advanced to the intended location and a stent was implanted. Post stent implantation, the filter was attempted to be retrieved into the retrieval catheter when the Barewire fractured resulting in the filter becoming separated and remaining in the distal ICA. Therefore, the patient was transferred to vascular surgery, and open surgical arteriotomy was performed to remove the Barewire separation and filter. The patient experienced bleeding which was resolved via routine heparin during surgery. No additional information was provided.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50016651 ↗
• InjuryMay 19, 2026Entrapment of Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, HEAVILY TORTUOUS LEFT INTERNAL CAROTID ARTERY LESION. AN EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM WAS USED. HOWEVER, THE PHYSICIAN WAS UNABLE TO RETRIEVE THE FILTER FOR 45 MINUTES. A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS PERFORMED TO RETRIEVE THE FILTER AND COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS FOUND THAT THE FILTRATION ELEMENT WAS RETURNED FULLY LOADED INTO THE RETRIEVAL CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25218424 ↗
• MalfunctionMay 14, 2026Break; Premature Activation; Stretched

  IT WAS REPORTED THAT PRIOR TO USE WHEN THE NAV6 EMBOLIC PROTECTION SYSTEM WAS ABOUT TO BE INSERTED INTO THE COPILOT, THE BAREWIRE TIP UNRAVELED AND THE FILTER CAME OUT OF THE DELIVERY CATHETER. THE FILTER WAS NOTED TO BE ELONGATED THEREFORE THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25172054 ↗
• MalfunctionApr 10, 2026Break

  IT WAS REPORTED THAT DURING PREPARATION OF THE NAV6 EMBOLIC PROTECTION SYSTEM (EPS), THE FILTER STRUT WAS NOTED TO BE BROKEN. A NEW EPS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839458 ↗
• MalfunctionMar 30, 2026Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 70-80% STENOSED INTERNAL CAROTID ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE LARGE EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM (EPS) WAS ADVANCED TO THE INTENDED TO LOCATION; HOWEVER, ADVANCEMENT TOOK SEVERAL ATTEMPTS. THE FILTER WAS DEPLOYED, BUT WHEN THE DELIVERY CATHETER WAS BEING REMOVED, THE BAREWIRE AND FILTER WERE REMOVING WITH THE DELIVERY CATHETER. THEREFORE, THE DEPLOYED FILTER AND BAREWIRE WERE PULLED INTO THE INTRODUCER SHEATH, AND EVERYTHING WAS REMOVED AS A SINGLE UNIT. ANOTHER EMBOSHIELD EPS, WAS USED, FOLLOWED BY IMPLANTATION OF AN ACCULINK STENT AND DILATATION WITH A VIATRAC BALLOON. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED, AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713047 ↗
• InjuryMar 25, 2026Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS SUPERFICIAL FEMORAL ARTERY LESION USING AN EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS). WHEN THE EPS WAS INSERTED INTO THE ANATOMY, IT WAS NOTED THAT THE FILTER WASN'T PULLED ALL THE WAY INTO THE POD; THEREFORE, RESISTANCE WAS FELT GETTING THE FILTER AND BAREWIRE TO THE TARGET LESION. AN ATTEMPT WAS MADE TO DEPLOY THE FILTER, BUT THE BAREWIRE DID NOT MOVE THE FILTER. IT WAS NOTED THAT THE TIP OF THE BAREWIRE HAD BENT AND SEPARATED. THE EPS WAS REMOVED FROM THE PATIENT AND THE PROCEDURE CONTINUED. POST TREATMENT, A BALLOON WAS USED TO PUSH THE SEPARATED TIP INTO THE VESSEL WALL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24691867 ↗
• MalfunctionMar 24, 2026Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS LEFT CAROTID ARTERY. THE BAREWIRE OF THE LARGE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS) COULD NOT MOVE INDEPENDENTLY FROM THE FILTRATION ELEMENT. THE FILTRATION ELEMENT AND BAREWIRE WERE REMOVED TOGETHER. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675749 ↗
• InjuryMar 24, 2026Retraction Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). PRIOR TO USE THE BAREWIRE OF THE LARGE EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM (EPS) WAS EXCHANGED FOR A .014 VIPER GUIDE WIRE (GW). AFTER USE IN THE PROCEDURE, WHEN REMOVING THE FILTER, THE FILTER CAME OFF THE VIPER GW. THEREFORE, A SNARE WAS USED TO RETRIEVE THE FILTER. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675607 ↗
• MalfunctionMar 23, 2026Difficult to Remove; Stretched; Improper or Incorrect Procedure or Method; Material Split, Cut or Torn

  SUBSEQUENTLY AFTER THE INITIAL REPORT WAS FILED, IT WAS NOTED THAT THE POLYIMIDE OLIVE (CONNECTOR PIECE INSIDE THE FILTER DEVICE) OF THE EPS, WAS TORN AND STRETCHED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663799 ↗
• InjuryMar 2, 2026Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN INTERNAL CAROTID ARTERY LESION. AN EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM WAS ADVANCED HOWEVER RESISTANCE WAS FELT WHILE ADVANCING THE BAREWIRE TO THE TARGET LESION AND THE DISTAL TIP SEPARATED. THE PHYSICIAN USED A STENT TO TRAP THE SEPARATED TIP AGAINST THE CAROTID ARTERY. AN ADDITIONAL EMBOSHIELD NAV6 DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELA AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24490189 ↗
• InjuryFeb 3, 2026Difficult to Remove; Retraction Problem; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT INTERNAL CAROTID ARTERY. THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS) WAS BEING ADVANCED TO THE LESION; HOWEVER IT WAS NOTED THAT THE WIRE WAS TRAPPED AROUND THE TIP OF THE GUIDE WIRE SHEATH. AT THIS POINT THE FILTER WAS DEPLOYED IN ORDER TO BE RETRIEVED. WHEN RETRIEVING THE FILTER, THE WIRE SHEARED, WHICH LEFT THE DISTAL TIP OF THE WIRE PINNED AGAINST THE VESSEL WALL AND SHEATH. A SNARE WAS USED TO RETRIEVE THE SEPARATED TIP OF THE WIRE. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248609 ↗
• MalfunctionJan 28, 2026Break; Difficult to Insert; Material Twisted/Bent

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNKNOWN ARTERY IN THE LOWER EXTREMITY. THE EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM (EPS) HAD NO BUNCHING OR WRINKLING OBSERVED ON THE DELIVERY CATHETER (DC) PRIOR TO LOADING. WHEN LOADING THE FILTRATION ELEMENT INTO THE DC WITH THE TORQUE DEVICE, IT WAS NOTED THAT THE TIP OF THE DC WAS BENT. AS A RESULT, THE FILTRATION ELEMENT COULD NOT BE LOADED INTO THE DC. ANOTHER EMBOSHIELD NAV 6 WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THE POLYIMIDE OLIVE WAS PARTIALLY SEPARATED AT THE PROXIMAL END OF THE FILTRATION ELEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24202763 ↗
• MalfunctionJan 28, 2026Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE INTERNAL CAROTID ARTERY WITH MODERATE CALCIFICATION AND HEAVY TORTUOSITY. THE EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM WAS PREPARED PER INSTRUCTIONS FOR USE (IFU) AND DEPLOYED IN THE TARGET LESION. A BUDDY WIRE WAS PUT IN WITH THE NAV 6 AND SHOCKWAVE DEVICE WAS USED IN THE LESION. AN ACCULINK STENT WAS DEPLOYED WITHOUT ISSUES. AFTER REMOVAL OF THE ACCULINK DEVICE WITHOUT LIVE FLUOROSCOPY, X-RAY WAS PERFORMED AND THE FILTER WAS NOTED TO BE MISSING FROM THE BAREWIRE. THE FILTER WAS NOTED TO BE LODGED AT THE TIP OF THE ACCULINK DELIVERY SYSTEM OUTSIDE THE ANATOMY. THE BAREWIRE WAS SIMPLY REMOVED WITHOUT ISSUES AND THE PROCEDURE WAS COMPLETED. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24201619 ↗
• MalfunctionJan 26, 2026Break; Stretched

  IT WAS REPORTED THAT WHEN THE NAV6 EMBOLIC PROTECTION SYSTEM (EPS) WAS REMOVED FROM THE PACKAGE, IT WAS NOTED THE TIP OF THE BAREWIRE WAS DAMAGED, THE TIP COILS WERE STRETCHED AND BROKEN. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24177680 ↗
• InjuryJan 23, 2026Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT INTERNAL CAROTID ARTERY. THE NAV6 EMBOLIC PROTECTION SYSTEM (EPS) WAS ADVANCED TO THE TARGET LESION AND DEPLOYED WITHOUT ISSUE. THE RETRIEVAL CATHETER WAS THEN ADVANCED TO CAPTURE THE FILTER; HOWEVER, IT WAS NOTED THE BAREWIRE HAD SEPARATED WITH THE FILTER ON IT. A SNARE DEVICE WAS USED TO RETRIEVE THE BAREWIRE AND FILTER AND REMOVE IT FROM THE PATIENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160462 ↗
• MalfunctionJan 12, 2026Difficult to Insert; Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING PREPARATION OF THE LARGE EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM (EPS), THE DELIVERY CATHETER (DC) POD BECAME BENT WHEN LOADING THE FILTER INTO THE DC POD. THE CORE OF THE BAREWIRE BECAME SEPARATED. THEREFORE, THE EPS WAS NOT USED IN THE PROCEDURE. ANOTHER EMBOSHIELD EPS WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24041262 ↗
• MalfunctionJan 5, 2026Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE CAROTID ARTERY. THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS) WAS DEPLOYED. THE XACT SELF EXPANDING STENT SYSTEM (SESS) RELEASED THE STENT BY 1/3 BUT THE REMAINING PORTION COULD NOT BE RELEASED. THE 8FR GUIDING CATHETER THAT WAS ALREADY INSIDE THE ANATOMY WAS USED TO RETRACT THE STENT AND THE EMBOSHIELD NAV6 EPS FILTER WAS REMOVED WHEN THE STENT WAS REMOVED. ANOTHER SAME SIZE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23963414 ↗
• MalfunctionJan 2, 2026Difficult to Remove; Retraction Problem; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY. THE EMBOSHIEDLD NAV6 EMBOLIC PROTECTION SYSTEM (EPS) WAS PREPPED AND ADVANCED OVER THE VIPEWIRE INTO THE ANATOMY. THE EMBOSHIELD NAV6 FILTER WAS DEPLOYED IN THE DISTAL POPLITEAL ARTERY WITH THE VIPERWIRE PLACED IN THE DISTAL PERONEAL ARTERY. THE SFA AND PROXIMAL POPLITEAL WERE TREATED WITH ORBITAL ATHERECTOMY AND THEN ANGIOPLASTY WAS PERFORMED. THE RETRIEVAL CATHETER OF THE EMBOSHIELD WAS ADVANCED TO THE PROXIMAL MARKER OF THE DEVICE AND THE VIPERWIRE WAS RETRACTED BACK UNTIL THE RETRIEVAL CATHETER ENCAPSULATED THE FILTER BUT THE FILTER WOULD NOT FULLY RETRACT SO THE VIPERWIRE AND CATHETER WERE PULLED TOGETHER. IT WAS WATCHED UNDER FLUORO AS THE FILTER/CATHETER/WIRE WERE BEING PULLED BACK, IT GOT SLIGHTLY STUCK IN AN IN-STENT STENOSIS PORTION OF THE MID SFA FOR A FEW SECONDS BUT EVENTUALLY RELEASED AND CONTINUED TO MOVE SMOOTHLY THROUGH REST OF STENT/VESSEL UNTIL IT GOT TO THE TIP OF THE 6FR INTRODUCER SHEATH. UPON TRYING TO PULL EVERYTHING OUT THROUGH THE SHEATH, THE VIPERWIRE PULLED COMPLETELY THROUGH THE FILTER ITSELF LEAVING THE FILTER STUCK AT THE TIP OF THE SHEATH ALONE. THE PHYSICIAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23950346 ↗
• MalfunctionJan 2, 2026Difficult to Insert; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE OF THE EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM (EPS), DURING PREP, THE FILTER COULD NOT BE INSERTED INTO THE DELIVERY CATHETER (DC) POD. THE DEVICE WAS PULLED AND THE TRAY WAS PUSHED DOWN BUT THE FILTER WOULD NOT GO IN AND THE DEPLOYMENT HANDLE ENDED UP SEPARATING. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW EMBOSHIELD WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23945644 ↗
• MalfunctionDec 23, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LOWER LIMB. THE NAV6 EMBOLIC PROTECTION SYSTEM (EPS) WAS ADVANCED TO THE TARGET LESION WITH AN ATHERECTOMY DEVICE HOWEVER THE DEVICE BECAME STUCK ON THE BAREWIRE. THE ATHERECTOMY DEVICE COULD NOT BE REMOVED THEREFORE THE PROCEDURE WAS STOPPED. THE DEVICE WAS REMOVED WITH THE BAREWIRE AND THE PROCEDURE COMPLETED WITH BALLOON ANGIOPLASTY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878593 ↗
• MalfunctionDec 18, 2025Break; Stretched; Deformation Due to Compressive Stress; Break; Stretched; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING PREPARATION OF THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS), THE BAREWIRE TIP WAS NOTED TO HAVE BROKEN AND STRETCHED COILS. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. A NEW EMBOSHIELD NAV6 EPS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23842411 ↗