EDWARDS CERTITUDE INTRODUCER SHEATH SET 9600IS18Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00690103194173), received between May 6, 2021 and May 9, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult to Insert” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2023Difficult to Insert; Patient-Device Incompatibility; Difficult to Advance; Difficult to Insert; Patient-Device Incompatibility; Difficult to Advance

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, DIFFICULTY INSERTING THE SHEATH INTO THE PATIENT AND A DISSECTION IN THE CAROTID ARTERY OCCURRED. A PLANNED VASCULAR CUTDOWN OF LEFT CAROTID ARTERY WAS DONE FOR ACCESS. A 18FR CERTITUDE SHEATH EXPERIENCED MORE RESISTANCE THAN USUAL DURING INSERTION. A 29 MM SAPIEN 3 VALVE WAS SUCCESSFULLY DEPLOYED IN THE AORTIC ANNULUS. AS THE SHEATH WAS REMOVED AT THE END OF THE PROCEDURE, A DISSECTION WAS FOUND IN THE CAROTID ARTERY. THE CAROTID ARTERY WAS SURGICALLY REPAIRED WITH A GRAFT. ANGIOGRAPHY AFTER THE SURGICAL REPAIR SHOWED A DISSECTION PROXIMAL TO THE GRAFT AND A CLAMP TISSUE INJURY DISTAL TO THE GRAFT. A COVERED STENT WAS THEN PLACED TO COVER BOTH PROXIMAL AND DISTAL DISEASED AREAS OF CAROTID AND GRAFT SEGMENT. FINAL ANGIOGRAPHY REVEALED BRISK CAROTID FLOW. THE PATIENT IS RECOVERING WELL AND WAS DISCHARGED ON POST OPERATIVE DAY 4. THE FIELD CLINICAL SPECIALIST REPORTED THAT THE PERCEIVED ROOT CAUSE OF THE INSERTION DIFFICULTY WAS CAROTID ARTERY LUMEN SIZE AND CAROTID ARTERY DISEASE.

  Patient problems: Vascular Dissection

  MAUDE report 16896194 ↗
• InjuryMay 6, 2021Difficult to Insert; Difficult to Insert

  AS FOUND REPORTED BY THE FIELD CLINICAL SPECIALIST, POST VALVE DEPLOYMENT, BLEEDING WAS NOTED AT THE CAROTID INSERTION SITE. HEMOSTASIS ACHIEVED BUT ONCE THE CERTITUDE SHEATH WAS REMOVED, THE BLEEDING PERSISTED. MULTIPLE SUTURES WERE NEEDED TO ACHIEVE HEMOSTASIS. THE PHYSICIAN BELIEVED THE TRANSITION OF DILATOR/SHEATH GOT CAUGHT ON SOME CALCIFICATION AND MAY HAVE TORN THE CAROTID ARTERY. THERE WAS SOME DIFFICULTY INSERTING THE SHEATH, HOWEVER THE PHYSICIANS FELT CALCIFICATION INTERACTING WITH THE ESHEATH ON INSERTION MAY BE THE CAUSE OF THE INJURY.

  Patient problems: Perforation of Vessels

  MAUDE report 11788475 ↗

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