ENTERRA ™ 4351-35 (UDI 00643169175006)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169175006), received between Jun 3, 2015 and Sep 21, 2017 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2017Break; Break

  NO NEW INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6883334 ↗
• MalfunctionMay 19, 2017Break; Break

  THE MANUFACTURE REPRESENTATIVE REPORTED THAT THE PATIENT¿S HEALTHCARE PROVIDER BROKE THE LEAD DURING THE PROCEDURE. THE MANUFACTURE REPRESENTATIVE NOTED THAT THERE WAS NO ISSUE WITH THE PRODUCT ITSELF, THE SURGEON JUST BROKE IT. NO MEDICAL SYMPTOMS WERE REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6578504 ↗
• MalfunctionJan 25, 2017Break; Device Operates Differently Than Expected; Break; Device Operates Differently Than Expected

  A MANUFACTURING REPRESENTATIVE (REP) REPORTED THAT DURING A PROCEDURE, THE HEALTHCARE PROVIDER WAS IMPLANTING THE LEAD ROBOTICALLY. AFTER THEY IMPLANTED THE ELECTRODE, THE PROLENE SUTURE ATTACHED TO THE NEEDLE SNAPPED. THE HCP DROVE THE REMAINING SUTURE END THROUGH ONE OF THE EYELETS ON THE SILICONE DISK INSTEAD OF DRIVING THE NEEDLE THROUGH THE CENTER OF THE DISK. HE FINISHED THE CASE WITH NO PROBLEM AND THE DISK WAS LAYING FLAT ON THE STOMACH AS THEY DESIRED. IT WAS NOTED THAT THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THERE WAS NO SURGICAL INTERVENTION AND NO PATIENT SYMPTOMS REPORTED. THE INDICATION FOR USE WAS FOR GASTRIC STIMULATION/GASTROINTESTINAL/PELVIC FLOOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6278278 ↗
• MalfunctionJan 13, 2017Break; Break

  ADDITIONAL INFORMATION FROM THE REP REPORTED THEY WERE NOT SURE WHAT CAUSED THE SUTURE TO SNAP OTHER THAN TRYING TO PULL THE LEAD THROUGH A 5MM TROCAR. IT GOT CAUGHT ON SOMETHING AND THEN SNAPPED WHILE TRYING TO DROP IT IN THE ABDOMEN, DURING THE LAPAROSCOPIC PLACEMENT. THEY WERE NOT SURE OF THE DEVICE WOULD BE RETURNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6251102 ↗
• MalfunctionJun 3, 2015Break; Device Damaged Prior to Receipt by User; Positioning Problem

  IT WAS REPORTED THE SKI-NEEDLE TIP (INSERTION NEEDLE) OF THE LEAD WAS BROKEN OFF WHEN THE LEAD WAS OPENED. THE SKI-NEEDLE WAS DETACHED FROM THE POLYPROPYLENE MONOFILAMENT. THE LEAD DID NOT HAVE ANY CONTACT WITH THE PATIENT. NO FURTHER INFORMATION WAS REPORTED. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 4814674 ↗