G-ARMOR STENT® 614761Recalls & reported problems
B Braun Interventional Systems, Inc · G ARMOR GCM039 5.7cm 26mm 6cm 16F 10Z · Class 3 · Implant
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 04046955767472), received between Jun 2, 2025 and Jun 2, 2025 — classified as 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Insert1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2025Difficult to Insert; Difficult to Insert
AS REPORTED FROM THE USER FACILITY / DISTRIBUTOR - "THE G-AMMOR "TOOL" WAS TOO SMALL TO PROPERLY SLIDE ONTO THE STENT AND BIB BALLOON. ONLY ONE "TOOL" WAS AVAILABLE IN THE G-ARMOR PACKAGE (614761). ALSO THE COVERING WAS LOSE UPON OPENING AND WAS DIFFICULT TO KEEP IN PLACE."
Patient problems: Insufficient Information
MAUDE report 22123663 ↗
Other Aortic stent devices
- Minima Stent System - 6mm FG-0001Renata Medical, Inc. · Aortic Stent1 death10 reports
- CP Stent™ 614311B Braun Interventional Systems, Inc · Aortic stent6 reports
- CP Stent™ 614310B Braun Interventional Systems, Inc · Aortic stent3 reports
- CP Stent™ 614309B Braun Interventional Systems, Inc · Aortic stent3 reports
- CP Stent™ 614308B Braun Interventional Systems, Inc · Aortic stent3 reports
- Minima Stent System - 8mm FG-0002Renata Medical, Inc. · Aortic Stent2 reports
- CP Stent™ 614376B Braun Interventional Systems, Inc · Aortic stent2 reports
- CP Stent™ 614516B Braun Interventional Systems, Inc · Aortic stent2 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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