ESHEATH OPTIMA 14000ES16ARecalls & reported problems
Edwards Lifesciences LLC · eSheath Optima Introducer Set (16F) · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103220636), received between Dec 8, 2025 and Dec 8, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Puncture/Hole” (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.
Reports received per month
Most reported problems
Device problems
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 8, 2025Material Puncture/Hole; Material Puncture/Hole
AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), DURING IMPLANT OF A 29MM SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION VIA RIGHT TRANSFEMORAL APPROACH, IT'S NOTED THERE WAS SOME RESISTANCE WHILE ADVANCING THE DELIVERY SYSTEM WITH CRIMPED VALVE THROUGH THE 16F OPTIMA SHEATH DUE TO A KINK IN THE OPTIMA AS WELL AS A SMALL PUNCTURE FROM THE PATIENT'S TORTUOSITY OF THE RIGHT ILIAC. THE DELIVERY SYSTEM WAS ABLE TO BE PULLED OUT OF THE SHEATH. THERE WERE NO PATIENT INJURIES. THE VALVE WAS IMPLANTED SUCCESSFULLY, AND THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23742505 ↗
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- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
- Edwards eSheath+ Introducer set 914ESPEdwards Lifesciences LLC · Introducer, Catheter22 deaths532 reports
- Fast-Cath™ 406849St. Jude Medical, Inc. · INTRODUCER, CATHETER420 reports
- VIZIGO D138503Biosense Webster Inc · INTRODUCER, CATHETER362 reports
- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
- Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-MSt. Jude Medical, Inc. · Introducer, catheter1 death301 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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