EMBOSHIELD NAV6Recalls & reported problems across all models

We found 2 models of EMBOSHIELD NAV6 by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 442 adverse event reports in the FDA's MAUDE database, received between Aug 17, 2016 and Sep 30, 2026 — classified as 1 death, 167 injuries, 274 malfunctions.

The most frequently reported specific device problem is “Material Separation” (136 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported EMBOSHIELD NAV6 problems

EMBOSHIELD NAV6 models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EMBOSHIELD NAV6 22438-19

  Temporary Carotid Catheter for Embolic Capture
  1 death348 reports
• EMBOSHIELD NAV6 22437-19

  Temporary Carotid Catheter for Embolic Capture
  94 reports

Recent EMBOSHIELD NAV6 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50949636 ↗
• 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 ↗
• InjuryJun 30, 2026Premature Activation; Difficult to Advance

  IT WAS REPORTED THAT THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS) WAS ADVANCED TO THE LESION AND SIGNIFICANT RESISTANCE WAS NOTED AND THE FILTER PREMATURELY DEPLOYED. THE FILTER WAS RETRIEVED WITH A NON-ABBOTT GUIDING CATHETER AND NOT USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25668274 ↗
• 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 ↗
• MalfunctionMay 4, 2026Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A TORTUOUS LESION IN THE INTERNAL CAROTID ARTERY. THE NAV6 EMBOLIC PROTECTION SYSTEM (EPS) WAS ADVANCED WITH RESISTANCE NOTED DUE TO THE TORTUOSITY OF THE COMMON CAROTID ARTERY. DURING REMOVAL OF THE FILTER WITH THE RETRIEVAL CATHETER, THE FILTER BECAME STUCK IN THE SHEATH. THE TIP OF THE RETRIEVAL CATHETER BROKE IN TWO AND SEPARATED FROM THE CATHETER. THE BARE WIRE WAS STILL IN PLACE; THEREFORE THE FILTER AND RETRIEVAL CATHETER WERE REMOVED WITHOUT INCIDENCE. 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 25069791 ↗
• 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 ↗

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