ENTERRA ™ 4351-35 (UDI 00643169887589)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169887589), received between Oct 7, 2017 and Aug 14, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2018Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS BEING IMPLANTED WITH A NEUROSTIMULATOR FOR GASTRIC STIMULATION. IT WAS REPORTED THAT THE PHYSICIAN WAS APPLYING THE CLIP ON THE BACKSIDE OF THE SILICON DISK, PER THE SURGICAL PROTOCOL, WHEN THE BLUE POLYPROPYLENE WAS CUT BY THE CLIP. AS A RESULT, THE DISK COULDN¿T BE SECURED BY THE SUTURE AND ANOTHER LEAD HAD TO BE OPENED. THIS LEAD WAS PLACED WITHOUT AN ISSUE. NO SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7782313 ↗
• MalfunctionDec 4, 2017Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  INFORMATION RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE REPORTED UPON PLACING A 5 MM CLIP ONTO THE PROLENE SUTURE PART OF THE LEAD, THE SUTURE SNAPPED. THE HCP WAS UNABLE TO PLACE A SECOND CLIP ONTO THIS PARTICULAR LEAD, SO HE LEFT IT WITH 1 CLIP. IT WAS UNKNOWN IF ANY FACTORS LED TO THE EVENT, OR IF ANY TROUBLESHOOTING WAS PERFORMED. NO ACTIONS WERE TAKEN. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO SYMPTOMS WERE REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED AND/OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7079055 ↗
• MalfunctionOct 23, 2017Break; Break

  A MANUFACTURING REPRESENTATIVE (REP) REPORTED ON BEHALF OF A CONSUMER THAT THE SKI NEEDLE FELL OFF THE LEAD RATHER EASILY AFTER BEING REMOVED FROM PACKAGING BEFORE GOING INTO THE PATIENT. THE OPERATING ROOM SET THE NEEDLE ASIDE AND USED ANOTHER ONE. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6968659 ↗
• MalfunctionOct 7, 2017Break; Break

  A MANUFACTURING REPRESENTATIVE (REP) REPORTED ON BEHALF OF A HEALTHCARE PROVIDER (HCP) THAT DURING A PROCEDURE THE HCP SNAPPED THE LEAD DUE TO USER ERROR. THE HCP STATED THAT THEY JUST HANDLED THE LEAD POORLY AND NOTHING WAS WRONG WITH THE LEAD. THE LEAD WAS NEVER IMPLANTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6926829 ↗