EDWARDS CERTITUDE INTRODUCER SHEATH SET 9600IS21Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00690103194180), received between Jun 6, 2021 and Mar 26, 2026 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (3 reports).

3 other recalls cover devices cleared under the same FDA submission (P140031); they may or may not involve this specific model.

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

• MalfunctionMar 26, 2026Detachment of Device or Device Component

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), THE PATIENT WAS UNDERGOING A TRANSCAROTID VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE USING A 23 MM SAPIEN 3 ULTRA RESILIA VALVE. THE VALVE WAS BEING IMPLANTED INSIDE A NON-EDWARDS VALVE. DURING THE PROCEDURE, THERE WAS RESISTANCE WHEN ADVANCING THE CERTITUDE DELIVERY SYSTEM WITH VALVE THROUGH THE 21FR CERTITUDE SHEATH, BUT THE DELIVERY SYSTEM WITH VALVE WAS ABLE TO EXIT THE TIP OF THE SHEATH. AFTER EXITING THE TIP OF THE SHEATH, THERE WAS DIFFICULTY ADVANCING THE DELIVERY SYSTEM THROUGH THE STRUTS OF THE NON-EDWARDS VALVE. IT WAS NOTED THAT THE IMPLANTING TEAM WAS BEHIND THE STRUTS OF THE NON-EDWARDS VALVE. THE DELIVERY SYSTEM CROSSED THE STRUTS AT THE MID VALVE PART OF THE VALVE AND WAS ON THE OUTSIDE OF THE NON-EDWARDS VALVE. THE SHEATH WAS PULLED BACK AND THEN THE SHEATH WAS USED TO PROVIDE MORE SUPPORT WHEN IT WAS NOTICED THAT THE TIP OF THE CERTITUDE SHEATH HAD "BROKE OFF". THE TIP OF THE SHEATH WAS NOTED TO BE STUCK AROUND THE SAPIEN 3 ULTRA RESILIA VALVE. THE VALVE WAS NOT DEPLOYED. THE DELIVERY SYSTEM WITH VALVE AND SHEATH WERE REMOVED AS A SINGLE UNIT. A NEW 21FR CERTITUDE SHEATH AND 23 MM CERT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24702738 ↗
• InjuryJul 14, 2023Difficult to Insert; Difficult to Insert

  EDWARDS RECEIVED NOTIFICATION FROM A FIELD CLINICAL SPECIALIST THAT A PATIENT UNDERWENT TAVR VIA THE LEFT CAROTID APPROACH. AS REPORTED, ACCESS WAS OBTAINED VIA A SURGICAL CUTDOWN AND THE INITIAL 21FR CERTITUDE SHEATH, 29MM CERTITUDE DELIVERY SYSTEM, AND 29MM SAPIEN 3 VALVE WERE PREPPED IN NORMAL FASHION. THE SHEATH WAS INSERTED TO APPROXIMATELY 4CM, BUT THE OPERATOR ADMITTED TO FEELING RESISTANCE WHILE INSERTING IT. HOWEVER, ONCE THE VALVE AND DELIVERY SYSTEM MADE IT THROUGH THE SHEATH, WITH ADMITTED "EXTRA FORCE", THE VALVE WAS NOTABLY PUSHED UP ON THE BALLOON. THE TEAM DECIDED TO CONTINUE ADVANCING THE DEVICE/VALVE, BUT THE VALVE CONTINUED TO SLIDE UP ON THE BALLOON. THE DECISION WAS MADE TO PULL THE VALVE AND SHEATH OUT OF THE BODY IN EXCHANGE FOR A NEW SHEATH AND NEW DEVICE. NEW PRODUCT WAS OPENED AND PREPPED. ONCE THIS WAS DONE, THE SURGEON EXAMINED THE CAROTID ARTERY TO FIND THAT THERE WAS A "DISSECTION FLAP" PRESENT. A GRAFT/PATCH BY OPEN CUTDOWN WITH VASCULAR SURGERY WAS PERFORMED TO REPAIR THE INJURY. THE TEAM THEN DECIDED TO ABORT THE CASE. THE SECOND VALVE WAS OPENED AND PREPPED BUT NEVER WENT INTO THE PATIENT. THE PATIENT WAS NOTED TO BE DOING WELL AND RECOVERING. THE

  Patient problems: Vascular Dissection

  MAUDE report 17329798 ↗
• InjuryMar 9, 2023Difficult to Insert; Difficult to Insert

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSAXILLARY TAVR PROCEDURE WITH A 23MM SAPIEN 3 ULTRA VALVE, THE FIRST 21F CERTITUDE SHEATH WOULD NOT ADVANCE INTO THE AXILLARY/SUBCLAVIAN ARTERY. THE PHYSICIAN REQUESTED A NEW 21FR SHEATH. THIS PATIENT WAS AN AXILLARY/SUBCLAVIAN CUTDOWN. THE PHYSICIAN WAS UNABLE TO GET THE SECOND 21F CERTITUDE SHEATH TO ENTER THE VESSEL. THE VESSEL (ALTHOUGH NOT HEAVILY CALCIFIED), WAS VERY THIN WALLED AND DETERIORATED. THE VASCULAR SURGEON'S WERE CALLED TO REPAIR THE VESSEL. AFTER THE REPAIR, IT WAS DETERMINED THAT THIS PATIENT WOULD BE RESCHEDULED AS A TRANSAORTIC APPROACH. PER THE FCS, THE PHYSICIAN DID NOT ALLEGE THE EDWARDS DEVICES WERE DEFICIENT IN SOME WAY. THE PHYSICIANS FELT THE VASCULAR INJURY OCCURRED WITH THE FIRST CERTITUDE SHEATH. UPON REMOVAL IT APPEARED THE TIP OF THE FIRST CERTITUDE SHEATH WAS DAMAGED. THE DEVICES WERE PREPPED CORRECTLY. AT THIS TIME, THE PATIENT HAS NOT BEEN RESCHEDULED. A 3 MENSIO AND PHOTO HAVE BEEN PROVIDED FOR REVIEW.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 16513116 ↗
• InjuryNov 4, 2022Difficult to Insert; Difficult to Insert

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 23 MM SAPIEN 3 ULTRA VALVE VIA CAROTID, RESISTANCE WAS FELT UPON ADVANCING THE CERTITUDE SHEATH INTO THE CAROTID. THE SURGEON CONTINUED TO ADVANCE THE SHEATH WITH NO PROBLEM. UPON REMOVAL OF THE SHEATH, AN INTIMAL TEAR WAS NOTED. THE PATIENT REQUIRED A CAROTID REPAIR WITH A VASCULAR PATCH. THE PATIENT IS CURRENTLY IN STABLE CONDITION.

  Patient problems: Vascular Dissection

  MAUDE report 15737348 ↗
• InjuryDec 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, AFTER A SUCCESSFUL TAVR CASE BY CAROTID APPROACH THE PATIENT HAD AN ISCHEMIC STROKE ON THE DAY OF THE PROCEDURE. THE STROKE WAS CONFIRMED BY CT. THE PATIENT IS CURRENTLY IN REHAB WITH RESIDUAL L HEMIPARESIS, ALBEIT IMPROVED. THIS WAS LIKELY A RESULT OF CAROTID DISSECTION DURING ACCESS RATHER THAN VALVE.

  Patient problems: Stroke/CVA; Vascular Dissection

  MAUDE report 13006707 ↗
• MalfunctionJun 6, 2021Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED BY A FIELD CLINICAL SPECIALIST, DURING IMPLANT OF A 29 MM SAPIEN 3 VALVE IN THE AORTIC POSITION VIA TRANSAORTIC APPROACH THE TIP OF THE 21F CERTITUDE SHEATH ROLLED UP WHEN ATTEMPTING TO INSERT THE SHEATH INTO HIGHLY CALCIFIED AO.. A SECOND CERTITUDE SHEATH WAS OPENED AND USED WITHOUT ISSUE. NO PATIENT INJURIES WERE REPORTED. THE PATIENT WAS DOING WELL POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11944446 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140031. One submission often covers many models, so check the product and lot details in each record.

• Z-0835-2019 · Jan 22, 2019 · Terminated
  Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US) 00690103193930 9600LDS20J 00690103194852 9600LDS23A (US) 00690103193947 9600LDS
• Z-2435-2018 · Jun 11, 2018 · Terminated
  Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
• Z-0293-2018 · Jul 21, 2017 · Terminated
  Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The Edwards Certitude Delivery System is used for delive