ESHEATH OPTIMA INTRODUCER SET (14F) 14000ES14Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00690103220629), received between Jun 12, 2025 and Jul 14, 2025 — classified as 1 injury, 1 malfunction.

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

• InjuryJul 14, 2025Difficult to Insert; Difficult to Insert

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING IMPLANT OF A 23 MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION, THE SURGEON USED THE 21F IN-SHEATH DILATOR (ISD) TO PREDILATE THE SHEATH BEFORE PUTTING IN THE COMMANDER DELIVERY SYSTEM. THERE WAS QUITE A BIT OF FORCE WHILE PUTTING IN THE 21F ISD. DURING THE PRE-DILATION USING THE 21F THE TIP OF THE ISD WAS ABLE TO PROGRESS PAST THE ILIAC BIFURCATION IN THE ABDOMINAL AORTA TO THE END OF THE SHEATH. WHEN THE PHYSICIAN REMOVED THE SHEATH AT THE END OF THE CASE, THERE WAS AN ILIAC PERFORATION. THE SURGEON THOUGHT PERHAPS PREDILATING THE SHEATH WITH THE OPTIMA ISD CAUSED THE PERFORATION. THE SHEATH DID NOT HAVE ANY VISIBLE DAMAGE. THE SURGEON PUT IN A COVERED STENT AND CONTROLLED THE PERFORATION. THE PATIENT IS STABLE AND DOING OK.

  Patient problems: Perforation of Vessels

  MAUDE report 22501107 ↗
• MalfunctionJun 12, 2025Material Puncture/Hole; Material Integrity Problem; Material Puncture/Hole; Material Integrity Problem

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING THE TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 26 MM SAPIEN 3 ULTRA VALVE, POST SUCCESSFUL VALVE DEPLOYMENT, A PINHOLE WAS NOTED IN THE 14FR ESHEATH OPTIMA WHEN IT WAS WITHDRAWN FROM THE PATIENT. IT WAS BELIEVED TO HAVE BEEN CAUSED BY THE CALCIUM NODULE AFTER THE IN-SHEATH DILATOR (ISD) WAS USED TO HELP WITH DIFFUSING THE DISEASE IN THE ANATOMY. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 22195868 ↗