OptiSeal™ 1000093-006Recalls & reported problems
Greatbatch Ltd · Valved Peelable PTFE Introducer · Class 2
All models of OptiSeal (8)
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 00821329600586), received between Jul 31, 2017 and Jul 31, 2017 — classified as 1 malfunction.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Blood Loss1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 31, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED THE PHYSICIAN WAS PERFORMING A CEPHALIC CUT DOWN ON AN EXTREMELY OBESE PATIENT. THE CEPHALIC VEIN APPEARED LARGE AND MORE BLOOD THAN USUAL POOLED AND SPURTED OUT DURING THE PROCEDURE. THE PHYSICIAN STATED THAT THE PATIENT HAD HIGH VENOUS PRESSURE ALONG WITH THE INTRODUCER DOING A POOR JOB OF PREVENTING BACK BLEEDING THROUGH THE VALVE.
Patient problems: Blood Loss
MAUDE report 6755325 ↗
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- 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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