EDWARDS ESHEATH INTRODUCER SETRecalls & reported problems across all models

We found 4 models of EDWARDS ESHEATH INTRODUCER SET by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 973 adverse event reports in the FDA's MAUDE database, received between Oct 21, 2020 and Aug 19, 2026 — classified as 49 deaths, 255 injuries, 669 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (467 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 EDWARDS ESHEATH INTRODUCER SET problems

EDWARDS ESHEATH INTRODUCER SET models

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

• Edwards eSheath+ Introducer set 914ESP

  Introducer, Catheter
  22 deaths532 reports
• Edwards eSheath+ Introducer set 916ESP

  Introducer, Catheter
  18 deaths298 reports
• EDWARDS ESHEATH INTRODUCER SET 914ES

  Introducer, Catheter
  6 deaths104 reports
• EDWARDS ESHEATH INTRODUCER SET 916ES

  Introducer, Catheter
  3 deaths39 reports

Recent EDWARDS ESHEATH INTRODUCER SET adverse event reports

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

• MalfunctionAug 19, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50329088 ↗
• MalfunctionJun 25, 2026Material Split, Cut or Torn

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) DURING A RIGHT TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR)WITH A 29MM SAPIEN 3 ULTRA RESILIA VALVE WHEN PASSING THE 29MM COMMANDER DELIVERY SYSTEM (DS) WITH THE VALVE THROUGH THE 16F ESHEATH+ AND ARTERIOTOMY SITE, IT WAS FELT THE VALVE WAS STUCK ON THE SIDE WALL OF THE SHEATH RIGHT AFTER THE STRAIN RELIEF PORTION. THE SURGEON USED A HEMOSTAT AROUND THE SHEATH TO DILATE THE TRACK AT WHICH POINT THE SYSTEM WAS ADVANCED AND THEN THE DS AND VALVE CONTINUED TO ADVANCE WITHOUT DIFFICULTY. THE PROCEDURE WAS SUCCESSFUL, AND THERE WAS NO PATIENT HARM. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PERCEIVED ROOT CAUSE WAS THE SKIN TRACT WAS NOT DILATED ENOUGH. PER ENGINEERING EVALUATION, THE DISTAL TIP IS TORN RADIALLY AND AXIALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25618957 ↗
• MalfunctionJun 12, 2026Material Puncture/Hole

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TAVR PROCEDURE WITH A 29MM SAPIEN 3 ULTRA RESILIA VALVE, RESISTANCE WAS FELT DURING INSERTION OF THE VALVE WITH DELIVERY SYSTEM THROUGH THE 16FR ESHEATH+, AND THE VALVE GOT CAUGHT WITHIN THE PARTIALLY EXPANDABLE. A BENT TINE WAS NOTICED ON FLURO. THE DEVICES WERE REMOVED AND REPLACED. THE PROCEDURE WAS SUCCESSFUL. PER REPORT, THERE MAY HAVE BEEN INTERACTION WITH THE ESHEATH+ WHEN REMOVING THE 25MM TRU BALLOON CAUSING ISSUES GETTING INTO AND BACK THROUGH THE SHEATH. PER DEVICE IMAGE RECEIVED, THE ESHEATH+ HAS A SHEATH PUNCTURE WITH THE BENT VALVE TINES EXPOSED THROUGH THE PUNCTURE SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25488660 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING A PROCEDURE WITH A 23MM SAPIEN 3 ULTRA VALVE WAS IMPLANTED IN A FAILED NON-EDWARDS VALVE(26MM). THE PATIENT WAS TAKEN TO THE CATH LAB AFTER SOMETIME POST PROCEDURE FOR A PERFORATION IN THE LEFT COMMON ILIAC REQUIRING PLACEMENT OF A COVERED STENT AND WAS STABLE.

  Patient problems: Perforation of Vessels

  MAUDE report 25349882 ↗
• MalfunctionMay 27, 2026Deformation Due to Compressive Stress; Material Split, Cut or Torn; Physical Resistance/Sticking

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, DURING A SUBCLAVIAN TRANSCATHETER MITRAL VALVE REPLACEMENT PROCEDURE TO IMPLANT A 29 MM SAPIEN 3 ULTRA RESILIA VALVE INTO A PRE EXISTING SURGICAL ANNULOPLASTY RING, THE DELIVERY SYSTEM COULD NOT BE ADVANCED THROUGH THE 16 F ESHEATH+ AND THE VALVE HAD A BENT STRUT. DURING THE PROCEDURE, THERE WAS NO DIFFICULTY INSERTING THE ESHEATH AND THE ESHEATH WAS NOT INSERTED AT A STEEP ANGLE. HOWEVER, DUE TO USING RIGHT SUBCLAVIAN VEIN ACCESS, MORE SHEATH WAS OUTSIDE OF THE BODY THAN CUSTOMARY. THE DELIVERY SYSTEM WITH VALVE BECAME STUCK IN THE MIDDLE OF THE FULLY EXPANDABLE PORTION OF THE ESHEATH. RESISTANCE SEEMED TO BE MORE THAN USUAL PRIOR TO THE SYSTEM COMING TO A COMPLETE STOP. IT WAS THEN NOTED UNDER FLUOROSCOPY THAT A STRUT WAS BENT UP AT A ROUGHLY 90 DEGREE ANGLE TO THE NORMAL PLANE. THE SYSTEM WAS REMOVED AS A SINGLE UNIT. A NEW SYSTEM WAS PREPARED AND SUCCESSFULLY DEPLOYED. THERE WAS NO PATIENT INJURY AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE. THE CAUSE OF THE EVENT WAS UNCLEAR. THE ESHEATH WAS RETURNED FOR EVALUATION AND UPON VISUAL INSPECTION A LINER TEAR AND LINER STRAND WERE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25304474 ↗
• MalfunctionMay 22, 2026Material Puncture/Hole

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), DURING A TAVR PROCEDURE WITH A 23MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION, THE FIRST VALVE GOT CAUGHT IN THE ESHEATH. THE ENTIRE SYSTEM WAS REMOVED AND A 2ND VALVE AND DELIVERY SYSTEM WAS PLACED WITH GOOD RESULT. DURING DELIVERY SYSTEM INTRODUCTION INTO SHEATH, THE VALVE WOULD NOT ADVANCE IN THE SHEATH. IT WAS NOTICED THAT A TINE OF THE VALVE WAS LIFTED AWAY FROM PREPPED SYSTEM AND WAS CATCHING IN THE SHEATH. UPON FOLLOW UP, THE FCS ADVISED THAT DURING A TAVR PROCEDURE, NO DIFFICULTY WAS ENCOUNTERED DURING INSERTION OF THE ESHEATH, AND THE EXPANSION TOOL (ESHEATH+) AND LOADER WERE USED APPROPRIATELY WITH FULL INSERTION ACHIEVED. THE ESHEATH WAS INTRODUCED VIA RIGHT-SIDED ACCESS AT A STEEP ANGLE. THE DELIVERY SYSTEM AND VALVE DID NOT EXIT THE SHEATH, BECOMING LODGED NEAR THE TRANSITION BETWEEN THE BLUE AND WHITE PORTIONS OF THE SHEATH. THE SYSTEM WAS WITHDRAWN FROM THE PATIENT AS A SINGLE UNIT, AND INSPECTION IDENTIFIED A SMALL PINHOLE IN THE SHEATH. THE DEVICE HAD BEEN PREPARED AND THE VALVE CRIMPED PER IFU, WITH NO ISSUES DURING THE CRIMPING PHASE. NO VESSEL PRE-DILATION WAS PERFORMED. THE ORIGINAL SYSTEM WAS REMOVED AND REPL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25256658 ↗
• MalfunctionMay 21, 2026Material Integrity Problem

  IT WAS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), THAT DURING A TRANSCAROTID AORTIC VALVE REPLACEMENT PROCEDURE WITH A 29MM SAPIEN 3 VALVE, AFTER THE VALVE WAS DEPLOYED SUCCESSFULLY, THE ESHEATH+ WAS REMOVED AND NOTED THAT THE TIP WAS TORN. ALL PIECES APPEARED INTACT AND ATTACHED, BUT THERE WAS A TORN PORTION OF THE TIP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO INDICATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25244047 ↗
• MalfunctionMay 20, 2026Peeled/Delaminated; Detachment of Device or Device Component

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE USING A 29MM SAPIEN 3 ULTRA RESILIA VALVE, PRECLOSING THE ARTERY WAS CHALLENGING DUE TO THE PATIENT'S LARGE BODY HABITUS, AND INSERTION OF THE ESHEATH WAS DIFFICULT WHILE TUNNELING THROUGH A LONG, RESISTANT TISSUE TRACT AND INTO THE ARTERY. ONCE THE ESHEATH WAS FULLY INSERTED, THE TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE PROCEEDED AS PLANNED, AND A 29 MM SAPIEN 3 ULTRA RESILIA VALVE WAS SUCCESSFULLY DEPLOYED. INSERTION OF THE DELIVERY SYSTEM WAS MET WITH MODERATE RESISTANCE. UPON REMOVING THE DELIVERY SYSTEM, THERE WAS SIGNIFICANT RESISTANCE COMING BACK THROUGH THE ESHEATH. UNDER FLUOROSCOPY, IT APPEARED THAT THE RADIOPAQUE CUFF OF THE ESHEATH WAS NO LONGER AT THE DISTAL TIP OF THE ESHEATH, BUT RATHER MID SHEATH WITH THE DELIVERY SYSTEM. THE DECISION WAS MADE TO REMOVE THE DELIVERY SYSTEM AND ESHEATH TOGETHER. A 20MM DRYSEAL WAS THEN INTRODUCED AT THE SITE AND THE VASCULAR SURGERY TEAM WAS CALLED. UPON REMOVAL OF THE ESHEATH AND DELIVERY SYSTEM, IT WAS IDENTIFIED THAT THE INNER LINING OF THE ESHEATH SEPARATED FROM THE OUTER LINING AND BUCKLED ON ITSELF. VASCULA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233242 ↗
• InjuryMay 20, 2026Patient Device Interaction Problem

  PER THE FIELD CLINICAL SPECIALIST, DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE USING A 26MM SAPIEN 3 ULTRA RESILIA VALVE, THE VALVE WAS SUCCESSFULLY DEPLOYED. UPON REMOVAL OF THE 14FR ESHEATH, A SMALL DISSECTION WAS NOTED IN THE COMMON FEMORAL ARTERY. THE IMPLANTERS STENTED THE VESSEL AN MOVED THE PATIENT TO STANDARD RECOVERY. THE PERCEIVED ROOT CAUSE WAS THOUGHT TO BE THE SHEATH CAUGHT ON TO SOME CALCIUM, WHICH CAUSED THE VESSEL TO TEAR. THERE WAS NO MENTION OF AN EDWARDS PRODUCT BEING DEFICIENT IN ANY WAY AS A RESULT OF THIS ISSUE. PATIENT IS CURRENTLY STABLE AND IN RECOVERY.

  Patient problems: Vascular Dissection

  MAUDE report 25232238 ↗
• MalfunctionMay 18, 2026Material Split, Cut or Torn

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), A 26 MM EDWARDS TRANSCATHETER HEART VALVE SAPIEN 3 ULTRA RESILIA WAS IMPLANTED IN THE AORTIC POSITION. THE VALVE WAS REPORTED TO BE SUCCESSFULLY IMPLANTED, WITH NO CENTRAL LEAK OBSERVED, AND THE PATIENT WAS ALIVE AT THE END OF THE PROCEDURE. DURING THE PROCEDURE, A DEVICE-RELATED MALFUNCTION WAS ENCOUNTERED INVOLVING THE COMMANDER DELIVERY SYSTEM. DURING POST'DILATATION, THE BALLOON RUPTURED AT 6 ATMOSPHERES AND 24 CC, CONSISTENT WITH REPORTED CHARACTERISTICS OF BOTH A BALLOON BURST AND BALLOON TEAR (P1 AND P2). THERE WAS NO RETAINED VOLUME IN THE BALLOON. THE PHYSICIAN NOTED THE EVENT MAY HAVE BEEN POSSIBLY RELATED TO BULKY LEFT VENTRICULAR OUTFLOW TRACT (LVOT) CALCIUM. FOLLOWING THE RUPTURE, THERE WAS DIFFICULTY WITHDRAWING THE BALLOON INTO THE 14FR ESHEATH, DESPITE COAXIAL ALIGNMENT UPON REENTRY, FULL UNFLEXING OF THE DELIVERY SYSTEM, AND THE FLEX TIP POSITIONED AT THE TRIPLE MARKER. DUE TO THE INABILITY TO WITHDRAW THE SYSTEM, THE PHYSICIAN ELECTED TO REMOVE THE DELIVERY SYSTEM AND ESHEATH TOGETHER AS A SINGLE UNIT, WHICH REQUIRED A SURGICAL CUTDOWN. DURING REMOVAL, RESISTANCE WAS ENCOUNTERED AT THE ARTERIOTOMY SITE, AND IT WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25210456 ↗
• MalfunctionMay 18, 2026Material Split, Cut or Torn

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), IT WAS A CASE OF A 29 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH. DURING PROCEDURE, THERE WAS NO RESISTANCE DURING INSERTION OF THE ESHEATH. IT WAS NOTED THAT THE DELIVERY SYSTEM AND VALVE JUMPED FORWARD SLIGHTLY UPON CROSSING THE DISTAL TIP OF THE SHEATH. THERE WAS NO WITHDRAWAL DIFFICULTIES. AFTER THE ESHEATH WAS REMOVED, IT WAS NOTED THAT THE DISTAL TIP OF THE ESHEATH WAS TORN. THERE WAS NO PATIENT INJURY. THE PROVIDED POST-PROCEDURAL DEVICE IMAGE WAS REVIEWED AND SHEATH DISTAL TIP TORN RADIALLY WITH STRETCHING VISIBLE WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25203228 ↗
• MalfunctionMay 12, 2026Material Split, Cut or Torn

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, REGARDING IMPLANTATION OF A 26MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION. ACCESS WAS OBTAINED FROM THE LEFT SIDE. THE 14F ESHEATH PLUS WENT IN WITHOUT ISSUES. THE 26MM COMMANDER DELIVERY SYSTEM WENT IN WITHOUT ISSUES. THE 26MM SAPIEN 3 ULTRA RESILIA VALVE WAS DEPLOYED WITHOUT ISSUES. DURING REMOVAL OF THE 14 F ESHEATH PLUS, THE SHEATH HAD SPLIT COMPLETELY THROUGH AND THE INTRODUCER WAS STICKING OUT THROUGH THE SPLIT. THE PATIENTS PERIPHERALS WERE FINE AFTER THE PROCEDURE AND NO HARM DONE TO THE PATIENT. IMAGERY WAS PROVIDED FOR REVIEW AND THE PICTURE PROVIDED SHOWED A LINER TEAR. THE DEVICE WAS RETURNED FOR EVALUATION AND THE PRE DECONTAMINATION OBSERVATIONS SHOWED A DISTAL TIP SPLIT ON THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25151083 ↗
• MalfunctionMay 11, 2026Material Puncture/Hole

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), THE PATIENT WENT INTO COMPLETE HEART BLOCK AFTER THE AORTIC VALVE WAS CROSSED WITH A WIRE REQUIRING A TVP PLACEMENT. DURING VALVE DEPLOYMENT, BALLOON RUPTURE WAS NOTED. PHYSICIAN WAS ABLE TO GET THE RUPTURED BALLOON BACK INTO THE SHEATH AND TAKE EVERYTHING OUT AS A UNIT. DURING ASSESSMENT IT WAS NOTED THAT THE NOSE CONE ALONG WITH THE PART OF THE RUPTURED BALLOON WERE LEFT IN THE BODY. BOTH THE NOSE CONE AND PART OF THE RUPTURED BALLOON WERE THEN RETRIEVED USING A SNARE. DUE TO VASCULAR INJURY AND UNCONTROLLED BLEEDING, CUTDOWN WAS PERFORMED FOR REPAIR AND HEMOSTASIS WAS ACHIEVED. PATIENT DEPARTED THE HYBRID LAB IN STABLE CONDITION. UPON FOLLOW UP, THE FCS ADVISED THAT DURING THE PROCEDURE, A BALLOON-RELATED COMPLICATION WAS OBSERVED INVOLVING THE DELIVERY SYSTEM. THE EVENT INITIALLY PRESENTED AS A RADIAL BALLOON BURST (P1) AND SUBSEQUENTLY PROGRESSED TO A BALLOON TEAR (P2) AS THE DELIVERY SYSTEM WAS WITHDRAWN FROM THE BODY IN CONJUNCTION WITH THE SHEATH. AT THE TIME OF THE INITIAL BURST, THE BALLOON AND NOSE CONE REMAINED INTACT AS A SINGLE UNIT; HOWEVER, DURING DEVICE REMOVAL, THE ASSEMBLY SEPARATED INTO TWO PIECES. THE NOSE CON

  Patient problems: Insufficient Information

  MAUDE report 25143362 ↗
• MalfunctionMay 11, 2026Material Puncture/Hole; Physical Resistance/Sticking

  EDWARDS RECEIVED NOTIFICATION FROM A FIELD CLINICAL SPECIALIST THAT A PATIENT UNDERWENT RIGHT SIDE TRANSFEMORAL TAVR. AS REPORTED, DURING THE 1ST ATTEMPT, UPON ENTERING THE 29MM SAPIEN 3 ULTRA RESILIA VALVE INTO THE 16FR ESHEATH+, THERE WAS RESISTANCE NOTED AT THE FEMORAL HEAD AND THE 29MM COMMANDER SYSTEM WAS UNABLE TO BE ADVANCED. A TINE WAS SEEN "BOWING" ON FLUOROSCOPY AND AT THIS POINT THE SYSTEM AND SHEATH WAS REMOVED AS A UNIT. THE DELIVERY SYSTEM DID AND VALVE DID NOT EXIT THE TIP OF THE SHEATH. THE SHEATH HAD A VISIBLE WHAT APPEARED TO BE A PERFORATION WITH A STRUT JUST AT THE BEGINNING OF THE BLUE PORTION. A NEW 16FR ESHEATH+/29MM COMMANDER/29MM S3UR VALVE WERE PREPPED IN STANDARD FASHION AND IMPLANTED. ON THE SECOND ATTEMPT THERE WAS A LITTLE RESISTANCE BUT DELIVERY SYSTEM WAS ABLE TO TRACK AND PROCEDURE COMPLETED. ON REMOVAL OF THE SECOND SHEATH THE TIP WAS NOTED TO BE TORN. PER THE FIELD CLINICAL SPECIALIST, THE DAMAGE WAS CONSISTENT WITH SHEATH DISTAL TIP DAMAGE. THERE WAS NO WITHDRAW DIFFICULTY NOTED. ANGIOGRAM AFTER IMPLANT SHOWED NO VASCULAR INJURY PER THE INTERVENTIONAL CARDIOLOGIST. THE ORIGINAL COMMANDER/ SHEATH/ VALVE SYSTEM WILL BE RETURNED; THE SECOND SHEATH W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25143068 ↗
• MalfunctionMay 8, 2026Material Split, Cut or Torn

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS) DURING A TAVR PROCEDURE WITH A 29MM SAPIEN 3 ULTRA RESILIA VALVE, DURING SAPIEN 3 ULTRA RESILIA INSERTION, SOME RESISTANCE WAS SEEN AT THE DISTAL PORTION OF THE 16F ESHEATH+. DURING ESHEATH+ REMOVAL, A TORN DISTAL TIP WAS NOTED. NO ILL HARM TO PATIENT. PER ADDITIONAL INFORMATION PROVIDED BY THE FCS, THERE WAS NO DIFFICULTY INSERTING THE SHEATH INTO THE PATIENT. THE EXPANSION TOOL WAS USED AND THE LOADER WAS ABLE TO BE FULLY INSERTED IN THE SHEATH/SHEATH HOUSING. THE SHEATH WAS NOT INSERTED AT A STEEP ANGLE AND WAS NOT TORQUED DURING THE PROCEDURE. THERE WERE NO WITHDRAWAL ISSUES. THE PERCEIVED ROOT CAUSE OF THE EVENT WAS DUE TO VESSEL TORTUOSITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125453 ↗

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