Reliant ™ REL46Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000381523), received between Oct 21, 2021 and Mar 19, 2025 — classified as 3 deaths, 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR AORTIC REPAIR, THE REL46 RELIANT BALLOON CATHETER WAS UNABLE TO BE WITHDRAWN THROUGH THE NON-MDT SHEATH AFTER INFLATIONS. THE CATHETER WAS SEEN STRETCHING UNDER PRESSURE. THE PHYSICIAN ATTEMPTED MULTIPLE REMOVALS, MOVING THE DEVICE TO DIFFERENT LOCATIONS IN THE BODY TO CHANGE THE ANGLE, AND PULLING NEGATIVE WITHOUT THE FLOW VALVE. EVENTUALLY, THE DECISION WAS MADE TO REMOVE THE BALLOON WITH THE NON-MDT SHEATH FROM THE BODY AND INSERT A NEW SHEATH. THE ENDOVASCULAR AORTIC REPAIR CONTINUED AS NORMAL AFTER THE REL46 WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643642 ↗
• DeathMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A RELIANT STENT GRAFT BALLOON WAS USED DURING AN EMERGENCY ENDOVASCULAR TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM. THE DIAMETER OF THE PROXIMAL RENAL AORTA WAS 26MM PROXIMALLY AND 31.3MM DISTALLY WITH A SHORT NECK LENGTH OF 10MM. THE NECK WAS WIDE AND CONICAL WITH MILD CALCIFICATION AND SEVERE THROMBUS PRESENT. IT WAS REPORTED DURING THE INDEX PROCEDURE; THE RELIANT BALLOON WAS USED TO OCCLUDE THE AORTA AS A LIFE-SAVING MEASURE TO TRY AND MINIMIZE THE RUPTURE. BALLOON MAY HAVE BEEN OVER INFLATED IN ORDER TO OCCLUDE THE AORTA. IT WAS ALSO REPORTED THAT DURING THE INDEX PROCEDURE THE PHYSICIAN CANNULATED THE GATE AT ONE POINT, BUT WHILE REMOVING THE 12 FR NON-MEDTRONIC SHEATH LOST TOTAL ACCESS AND HAD TO PERFORM A CUT DOWN AND RE-ACCESS THE CONTRALATERAL SIDE. ONCE ACCESS WAS OBTAINED ON THE CONTRALATERAL SIDE, MULTIPLE ATTEMPTS WERE ATTEMPTED WITH VARIOUS CATHETERS WITHOUT SUCCESS. IT WAS THEN DECIDED TO ATTEMPT GATE CANNULATION FROM THE IPSILATERAL SIDE WITH THE USE OF A SNARE CATHETER. THIS WAS ACHIEVED AND THE CONTRALATERAL LIMB WAS SUCCESSFULLY DELIVERED. ONE DAY POST INDEX PROCEDURE, IT WAS FOUND THAT BALLOONING RESULTED IN INDUCED BILATERAL RENAL THROMBOSIS WITH BOTH R

  Patient problems: Ischemia; Obstruction/Occlusion

  MAUDE report 19357466 ↗
• DeathMar 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 53MM SACCULAR AAA IT WAS REPORTED DURING THE PROCEDURE, AFTER IMPLANTING THE MAIN BODY AND A LIMB, THE PHYSICIAN BEGAN VERY LIGHTLY BALLOONING THE PROXIMAL NECK SEAL ZONE. WHILE BALLOONING THERE WAS A CHANGE IN DIAMETER OF THE PROXIMAL NECK AND A RUPTURE WAS CONFIRMED. IT WAS CONFIRMED IT WAS A RELIANT BALLOON USED DURING THE INDEX PROCEDURE. THE PATIENTS BLOOD PRESSURE DROPPED AND SUSTAINED BALLOON INFLATION WAS USED TO MAINTAIN SYSTOLIC PRESSURE. THE PHYSICIAN  THEN OBTAINED LEFT ARM ACCESS AND USED A CHIMNEY TECHNIQUE TO PLACE A NON MDT STENT INTO THE LEFT RENAL ARTERY AND SUBSEQUENTLY PLACED A 25/25/49 AORTIC CUFF TO THE LEVEL OF THE RIGHT RENAL ARTERY.  AFTER BALLOONING,  THE CUFF HELPED SLOW THE EXTRAVASATION IN THE PROXIMAL NECK BUT THE PATIENT CONTINUED TO BE UNSTABLE AND THE PATIENT WAS  CONVERTED TO AN OPEN SURGICAL REPAIR. THE PHYSICIANS EXPLANTED THE CUFF AND THE BIFURCATED GRAFT EXCEPT FOR THE LIMBS, THE PHYSICIANS CUT OFF THE LIMBS DISTAL TO THE FLOW DIVIDER AND SEWED A AORTO BI-FEM GRAFT INTO THE EXISTING ENDOGRAFT LIMBS. THE PHYSICIAN REMOVED THE NON MDT STENT FROM THE LE

  Patient problems: Ischemia; Low Blood Pressure/ Hypotension; Rupture; Thrombosis/Thrombus

  MAUDE report 16512780 ↗
• DeathSep 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 68 MM ABDOMINAL AORTIC ANEURYSM.  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PATIENT EXPERIENCED A LEFT RENAL/ABDOMINAL AORTIC RUPTURE AFTER A EBTF2816C146E AND A ETLW1616C124E WERE IMPLANTED DUE TO PROXIMAL BALLOONING WITH A RELIANT BALLOON. THERE WAS A NOTICEABLE GIVE TO THE AORTA WHILE LOOKING AT THE GRAFT DURING THE BALLOONING. AS THE BALLOON PRESSURE WAS RELEASED THE PATIENTS BP DROPPED SIGNIFICANTLY. THE RELIANT BALLOON WAS THEN ADVANCED ABOVE THE SMA AND RE-INFLATED. SEVERAL ANGIOGRAMS WERE TAKEN AND AN EXTRAVASATION WAS SEEN JUST BELOW THE LEFT RENAL ARTERY. A 28X28X49 CUFF WAS PLACE APPROXIMATELY 3 MM ABOVE THE MAIN BODY GRAFT IN AN ATTEMPT TO COVER THE TEAR. THE PATIENT STABILIZED BUT THE APPEARANCE OF THE LEAK WAS STILL VISIBLE. THE PHYSICIAN'S THEN DECIDED TO TRANSFER THE PATIENT , SO THE PATIENT COULD HAVE FURTHER MORE COMPLEX INTERVENTION FOR THE RUPTURE, BUT THE PATIENT'S BLOOD PRESSURE DROPPED AGAIN WHILE THE PATIENT'S GROINS WERE BEING CLOSED. SEVERAL ATTEMPTS WERE MADE TO FIX THE TEAR ENDOVASCULARLY WITH NO SUCCESS AND THE DECISION TO CONVERT TO OPEN RE

  Patient problems: Insufficient Information; Low Blood Pressure/ Hypotension; Rupture

  MAUDE report 15445117 ↗
• MalfunctionFeb 1, 2022Burst Container or Vessel; Burst Container or Vessel

  AN ENDURANT IIS BIFURCATED STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 60MM ABDOMINAL AORTIC A NEURYSM.  IT WAS REPORTED DURING THE INDEX PROCEDURE THAT THE GRAFT WAS PLACED WITHIN 2MM OF THE LOWEST RENAL ARTERY. WHEN BALLOONING POST STENT GRAFT PLACEMENT WITHIN THE PROXIMAL PORTION OF THE GRAFT, TWO RELIANT BALLOONS RUPTURED UPON INFLATION. A NON-MDT BALLOON WAS THEN USED AND THIS BALLOON ALSO RUPTURED. AN ANGIOGRAPHY SHOWED THE PRESENCE OF A TYPE IA ENDOLEAK WITH INCOMPLETE EXPANSION OF THE GRAFT TO THE WALL ON THE RIGHT LATERAL ASPECT OF THE AORTA. 10 ENDOANCHORS WERE USED TO TREAT THE TYPE IA ENDOLEAK BUT THE ENDOLEAK PERSISTED.  AS PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK WAS DUE TO THE PATIENTS OWN ANATOMY. THE PHYSICIAN QUESTIONED IF THE BALLOON RUPTURING COULD BE ATTRIBUTED TO THE GRAFT NOT EXPANDING TO THE WALL TO SEAL OR WAS THERE POSSIBLY UNSEEN CALCIUM.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13413737 ↗
• InjuryOct 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 35MM ABDOMINAL AORTIC ANEURYSM. THE EXTERNAL ILIAC AND LEFT SFA ARE OCCLUDED. IT WAS REPORTED DURING THE INDEX PROCEDURE, THE PHYSICIAN STARTED WITH BI-LATERAL CUTDOWNS COMING FROM BELOW ON THE LEFT HOWEVER WAS NOT ABLE TO GET UP TO THE LEFT COMMON ILIAC. THE PHYSICIAN DECIDED TO COME UP AND OVER TO CROSS DOWN AND WAS ABLE TO GET A WIRE OUT THE LEFT COMMON FEMORAL WITH ACCESS ON BOTH SIDES TO THE AORTA. WHERE THE EXTERNAL ILIAC WAS OCCLUDED BALLOONING WITH A 5X10 AND 7X10 ANGIOPLASTY BALLOON WAS COMPLETED. THE GRAFTS WERE IMPLANTED AND ON THE LEFT SIDE AND EXTENDED WITH NON-MEDTRONIC STENTS. AFTER PLACING THE STENT GREAT FLOW OUT THE LEFT LIMB WAS OBSERVED. BOTH SIDES WERE BALLOONED WITH A RELIANT BALLOON. AFTER BALLOONING WITH THE RELIANT BALLOON THE LEFT LIMB WENT DOWN. A NON-MEDTRONIC BALLOON WAS USED TO PULL A CLOT OUT AND THE LIMB WAS RELINED WITH ANOTHER NON-MEDTRONIC STENT AND AN ADDITIONAL BALLOON EXPANDABLE STENT. AT THIS TIME THE LIMB HAD RESIDUAL CLOT BUT THE PHYSICIAN DECIDED TO STOP AND FOCUS ON THE LEG WHERE THE PROFUNDA WAS NOW OCCLUDED. THE PHYSICIAN USED A BALLOON TO P

  Patient problems: Myocardial Infarction; Obstruction/Occlusion

  MAUDE report 12670802 ↗