SafeSept Needle Free Transseptal Guidewire SSNFRecalls & reported problems
Ppmdm · 0.031" Transseptal guidewire. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00858769006111), received between Dec 21, 2018 and Jan 29, 2020 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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
Device problems
- Break2
- Use of Device Problem1
Patient problems
- Cardiac Perforation1
- Device Embedded In Tissue or Plaque1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 29, 2020Break; Break
IT WAS REPORTED THAT THE USER WAS UNABLE TO CROSS THE SEPTUM. THE WIRE WAS REMOVED FROM THE CANNULA, AND IT WAS NOTICED THAT THE DISTAL END WAS MISSING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9644694 ↗MalfunctionSep 9, 2019Break; Break
THIS WAS A DOUBLE TRANSSEPTAL PROCEDURE. THE WIRE CROSSED WITHOUT ANY ISSUES. THE PHYSICIAN WAS UNABLE TO CROSS THE SEPTUM WITH THE SHEATH. THE WIRE, DILATOR, AND CANNULA WERE REMOVED, LEAVING THE SHEATH IN THE RIGHT ATRIUM. WHEN REMOVING THE WIRE INTO THE DISPENSER, IT WAS NOTICED THAT THE DISTAL "J" PORTION OF THE WIRE WAS MISSING. IMAGING WAS USED AND FOUND THAT THE "J" PORTION OF THE WIRE REMAINED IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8977712 ↗InjuryDec 21, 2018Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT WHEN THE TRANSSEPTAL PUNCTURE WAS PERFORMED DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE UTILIZING THE SAFESEPT NEEDLE FREE TRANSSEPTAL GUIDEWIRE ALONG WITH A COMPETITOR DILATOR AND INTRODUCER SHEATH TO GAIN ACCESS TO THE LEFT ATRIUM, THE DILATOR PUNCTURED THE LEFT ATRIAL APPENDAGE. AS A RESULT, HEART SURGERY WITH A STERNOTOMY WAS PERFORMED TO CLOSE THE ATRIAL APPENDAGE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Cardiac Perforation
MAUDE report 8190245 ↗
Other Trocar devices
- BRK™ G407208St. Jude Medical Cardiovascular Division · Trocar3 deaths75 reports
- BRK™ 407200St. Jude Medical Cardiovascular Division · Trocar4 deaths71 reports
- NA EP003994SMedtronic, Inc. · Trocar60 reports
- Cook G02364Cook Incorporated · Trocar1 recall5 reports
- HeartSpan® 00884450489345Merit Medical Systems, Inc. · Trocar1 recall1 death2 reports
- Cook G01377Cook Incorporated · Trocar1 recall2 reports
- Cook G02365Cook Incorporated · Trocar1 recall0 reports
- Endrys G19261Cook Incorporated · Trocar1 recall0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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