ENTERRA® 4351-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00643169936577), received between Oct 4, 2018 and Mar 29, 2022 — classified as 6 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2022Extracardiac stimulation; Inappropriate/Inadequate Shock/Stimulation; Extracardiac stimulation; Inappropriate/Inadequate Shock/Stimulation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT OF THE STATE IS EXPERIENCING SHOCK AT THE POCKET SITE. NEEDS ASSISTANCE IN TURNING OFF THERAPY OR TURNING AMPLITUDE DOWN. THE CALLER WAS NOT WITH THE PATIENT. THE CALLER WAS REDIRECTED TO WARM TRANSFERRED TO NAS TO PAGE A LOCAL REP. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED AT THIS TIME.

  Patient problems: Electric Shock

  MAUDE report 13939305 ↗
• MalfunctionDec 10, 2021Impedance Problem; Insufficient Device Problem Information; Impedance Problem; Insufficient Device Problem Information

  ) NO NEW INFORMATION FOR THE EVENT DESCRIPTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12980321 ↗
• InjuryNov 30, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). THE REP STATED THAT THE CLIP APPLIER DIDN'T FIRE CORRECTLY CAUSING THE SUTURE TO SNAP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12892703 ↗
• MalfunctionMay 17, 2021Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP). THE HCP REPORTED THAT THE THIS EVENT OCCURRED ON (B)(6) 2021. THE CAUSE TO THE BROKEN LEAD BRAKE WAS UNDERMINED. IT WAS DURING THE APPLICATION OF A CLIP. THE BROKEN LEAD WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11833011 ↗
• MalfunctionMay 14, 2021Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN ENTER GASTRO LEAD AND AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED BY THE MANUFACTURER REPRESENTATIVE (REP) THAT DURING THE PROCEDURE, THE SKI NEEDLE POPPED/POPPED OFF DURING  HANDLING. THE REP NOTED THAT IT WAS NEVER IMPLANTED AND THAT IT WAS REPLACED WITH A NEW LEAD. THE REP WAS STATED TO HAVE HAD POSSESSION OF THE DEVICE AND IT WAS NOTED THAT THE PRODUCT WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11824154 ↗
• InjuryMay 11, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THE LEAD SUTURE WAS SNAPPED BY A METAL CLIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11806776 ↗
• InjuryMay 3, 2021Inappropriate/Inadequate Shock/Stimulation; Impedance Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Inappropriate/Inadequate Shock/Stimulation; Impedance Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT FELT "SHOCKS" LASTING UP 5 MINUTES. UPON INTERROGATION, IT WAS DISCOVERED THAT LEAD 2 WAS NOT WITHIN AN ACCEPTABLE IMPEDANCE RANGE. THE POLARITY OF THE DEVICE WAS CHANGED TO TURN OFF THAT LEAD UNTIL THE POCKET COULD BE EXPLORED. X-RAY DID NOT REVEAL ANYTHING ABNORMAL. PATIENT EXPERIENCED MORE NAUSEA WITH THAT LEAD TURNED OFF. PATIENT DECIDED TO MEDICATE AND POSTPONE IMPLANTATION OF A NEW LEAD. NO FURTHER COMPLICATIONS WERE REPORTED AT THIS TIME.

  Patient problems: Electric Shock; Nausea; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11764882 ↗
• MalfunctionJan 13, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE OPERATING NURSE WAS PRETTYING A SUTURE ONTO THE LEAD PRIOR TO IMPLANT AND ACCIDENTAL CUT THE PROLENE SUTURE ON THE LEAD. IT WAS NEVER INSIDE THE PATIENT. THEY HAD TO TOSS IT AND OPEN ANOTHER LEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11166961 ↗
• InjuryOct 22, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN IN DICATIONS FOR USE. IT WAS REPORTED THAT EXISTING LEADS WERE REPLACED BECAUSE THEY BROKE. THEY WERE REPLACED ON (B)(6) 2020.

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

  MAUDE report 10721041 ↗
• MalfunctionOct 1, 2020Entrapment of Device; Migration or Expulsion of Device; Insufficient Device Problem Information; Entrapment of Device; Migration or Expulsion of Device; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR GASTRIC STIMULATION. IT WAS REPORTED THE DOCTOR SNAPPED THE PROLENE SUTURE ATTACHED TO THE LEAD WITH THE CLIP APPLIER UPON INITIAL IMPLANT. AND THE HEALTH CARE PROVIDER THEN REMOVED THE LEAD AND IMPLANTED A NEW LEAD/ NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED AT THIS TIME.

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

  MAUDE report 10614474 ↗
• MalfunctionNov 8, 2019Break; Material Deformation; Break; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR GASTRIC STIMULATION. IT WAS REPORTED THAT THE NEEDLE, ATTACHED TO THE BLUE POLYPROPYLENE, BENT ENOUGH TO BE UNUSABLE. THE LEAD WAS NEVER IMPLANTED AND A BACK-UP LEAD WAS USED. ALL WENT WELL AND THE PATIENT WAS FINE. NO SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9296347 ↗
• InjuryJul 23, 2019Break; Human-Device Interface Problem; Break; Human-Device Interface Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE LEAD WAS PLACED AND THE SURGEON WENT TO SECURE IT WITH A CLIP APPLIER, AS INDICATED BY PROTOCOL, AND THE CLIP APPLIER CUT THE BLUE POLYPROPYLENE SUTURE ATTACHED TO THE SKI NEEDLE. THE SURGEON REMOVED THE LEAD AND REPLACED IT WITH A NEW LEAD WITHOUT ISSUE. THE PROCEDURE WENT WELL AND THE PATIENT WAS DOING FINE. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8816198 ↗
• MalfunctionFeb 1, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED DURING THE PROCEDURE THE PROLINE SUTURE ON THE LEAD SNAPPED DURING THE PLACEMENT. THE REP NOTED THE HCP REMOVED IT AND OPENED ANOTHER LEAD AND PLACED IT SUCCESSFULLY. THE REP NOTED THEY WERE UNABLE TO DETERMINE THE RETURN STATUS, THEY THOUGHT IT WAS THROWN AWAY. THE REP NOTED IT WAS UNKNOWN IF THERE WERE ANY ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE REP STATED IT WAS UNKNOWN IF THERE WAS ANY DIAGNOSTICS OR TROUBLESHOOTING PERFORMED. THE REP NOTED THE ACTIONS TAKEN TO RESOLVE THE LEAD SNAPPING WAS A NEW LEAD WAS PLACED AND THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THE PATIENT WAS LISTED AS ALIVE WITH NO INJURY AT THE TIME OF THE REPORT. THERE WERE NO FURTHER COMPLICATIONS THAT HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8298186 ↗
• MalfunctionJan 25, 2019Device Damaged Prior to Receipt by User; Appropriate Device Problem Term/Code Not Available; Device Damaged Prior to Receipt by User; Appropriate Device Problem Term/Code Not Available

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA MANUFACTURE REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THERE WAS A BENT SKI NEEDLE THAT WAS NOTICED IN THE LEAD PACKAGING. THE REP NOTED THAT VISUAL DETERMINATION DETERMINED THE DEFEAT. IT WAS NOTED THE NEEDLE WOULD BE RETURNED. IT WAS NOTED THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THERE WERE NO FURTHER COMPLICATIONS THAT HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8277633 ↗
• InjuryJan 17, 2019Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE LEAD BROKE WHEN THE SURGEON WAS PLACING IT; IT WAS REPLACED WITH A NEW LEAD. THE PATIENT STATUS WAS NOTED TO HAVE BEEN RECOVERED WITHOUT SEQUELA. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8257887 ↗
• MalfunctionOct 25, 2018Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR GASTRIC STIMULATION. IT WAS REPORTED THAT THE LEAD WAS NOT IMPLANTED AS IT WAS BROKEN. NO SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8004943 ↗
• MalfunctionOct 4, 2018Peeled/Delaminated; Device Damaged Prior to Receipt by User; Peeled/Delaminated; Device Damaged Prior to Receipt by User

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS BEING IMPLANTED WITH A NEUROSTIMULATOR FOR GASTRIC STIMULATION. IT WAS REPORTED THAT THE BLUE PROLENE SEPARATED ON THE LEAD. THE LEAD WAS NEVER IMPLANTED AND A NEW LEAD WAS USED. THIS ISSUE WAS NOTED TO BE RESOLVED. NO SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7934392 ↗