Enseal NSLX145CRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10705036015499), received between May 10, 2021 and Sep 17, 2026 — classified as 14 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (9 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Difficult to Open or Close; No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808536 ↗
• MalfunctionSep 17, 2026Difficult to Open or Close

  It was reported that during laparoscopic urological procedure after clamping the thick tissue, the jaws could no longer be opened. Main device was taken out, and the surgery was performed using an electric knife instead. No pieces were left inside the patient. There were no adverse consequences to the patient. No further information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808521 ↗
• MalfunctionSep 17, 2026Difficult to Open or Close; No Apparent Adverse Event

  It was reported that during a Radical Prostatectomy procedure when clamping the tissue near prostatic artery, the malfunction occurred that the jaws did not open. The surrounding tissues were dissected using an electrosurgical knife, and the operation was performed using an electrosurgical knife. No pieces were fell into the patient. There were no adverse consequences to the patient. No further information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808416 ↗
• MalfunctionJan 28, 2026Material Integrity Problem

  IT WAS REPORTED THAT A PIECE NEAR THE ARTICULATION JOINT CAME OFF INSIDE THE PATIENT DURING THE PROCEDURE. THEY RETRIEVED THE BROKEN PIECE. THIS WAS A BARIATRIC REVISION SLEEVE TO BYPASS. NO ADVERSE IMPACT PATIENT/USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24201745 ↗
• MalfunctionJun 30, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING HIATAL HERNIA THERE WAS BLOCKING OF THE SECTION TRIGGER OF THE FORCEPS. DELAY IN INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22360061 ↗
• MalfunctionAug 1, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PACKAGE BROKE COMPROMISING THE STERILITY OF THE ITEM. CASE WAS COMPLETED WITH A LIKE DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19886323 ↗
• MalfunctionJun 24, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT, DURING UNKNOWN PROCEDURE, 6 HOURS AFTER THE PROCEDURE STARTED, THE TIP OF THE DEVICE, THE RATCHET, COULD NOT BE OPENED HOLDING THE BLADDER. THE DEVICE WAS USED AS USUAL. THE TISSUE WHICH THE DEVICE HOLD WAS TOO HARD AND THICK. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19602635 ↗
• MalfunctionNov 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TIP IS BROKEN. NOTHING FELL INTO THE PATIENT. NO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18074339 ↗
• MalfunctionOct 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC OVARIAN CYSTECTOMY THE JAW BROKE. A NEW DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17869177 ↗
• InjuryAug 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY THE DEVICE ¿APPARENTLY¿ SEALED, BUT THEN WAS DROOLING. SURGEON REINFORCED SUTURES THROUGHOUT THE STAPLE LINE, REVIEWED ALL SURGERY TO ENSURE HEMOSTASIS. DEVICE PRESENTED DIFFICULTY IN SEALING DURING THE PROCEDURE, BUT THE DOCTOR DID NOT REQUEST REPLACEMENT. WITH 24 HOURS PATIENT EVOLVES WITH PALENESS, BLOOD TEST FOUND HEMOGLOBIN DROP AND ON TOMOGRAPHY, HEMATOMA AND FLUID PRESENCE WERE FOUND IN THE CAVITY. PATIENT REMAINS HOSPITALIZED (THE USUAL DISCHARGE IS IN 24 HOURS), NEEDED BLOOD TRANSFUSION, BUT EVOLVES WELL.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 17597596 ↗
• InjuryMar 30, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT POST OP TO A GASTRIC SLEEVE A CT SCAN REVEALED A BLEED FROM THE GASTRIC EDGE DISCOVERED WHILE IN RECOVERY. IT SELF RESOLVED BUT THE PATIENT RECEIVED ONE UNIT OF BLOOD. THEY HAVE SINCE BEEN DISCHARGED AND ARE DOING FINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16644221 ↗
• InjuryMar 30, 2023Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE SLEEVE GASTRECTOMY PROCEDURE, THE PATIENT WAS TAKEN BACK FOR AN UPPER ABDOMEN HEMATOMA. THE DOCTOR HAS NOTICED MORE BLEEDING AND LACK OF SEALING WITH THE DEVICE OVER THE LAST FOUR TO SIX WEEKS. PRODUCT IS USED ALONG THE GREATER CURVATURE. HEMOGLOBIN WENT FROM 14.4 TO 7.7. NO ACTIVE BLEEDING ONCE THEY GOT INTO THE ABDOMEN. ORIGINAL PROCEDURE DATE WAS (B)(6) 2023 SLEEVE GASTRECTOMY. BRING BACK WAS (B)(6) 2023. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: Hematoma

  MAUDE report 16643582 ↗
• InjuryMar 10, 2023Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A VERTICAL SLEEVE GASTRECTOMY PROCEDURE THE DEVICE WOULD NOT SEAL WHILE TAKING MESENTERIC VESSELS. THEY TRIED A SECOND AND IT WOULD NOT SEAL EITHER. THEN THEY USED A HARMONIC SCALPEL WHICH COMPLETED THE PROCEDURE WITH NO PATIENT CONSEQUENCES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16525335 ↗
• InjuryMar 10, 2023Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A VERTICAL SLEEVE GASTRECTOMY PROCEDURE THE DEVICE WOULD NOT SEAL WHILE TAKING MESENTERIC VESSELS. THEY TRIED A SECOND AND IT WOULD NOT SEAL EITHER. THEN THEY USED A HARMONIC SCALPEL WHICH COMPLETED THE PROCEDURE WITH NO PATIENT CONSEQUENCES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16525242 ↗
• InjuryMar 1, 2023Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE THAT WHILE TAKING THE OMENTUM DOWN THE DEVICE WAS CUTTING BUT NOT SEALING AT FULL CAPABILITY. A NSLG2S45A WITH THE SAME GENERATOR WAS USED TO COMPLETE THE PROCEDURE WITH NO ADDITIONAL ISSUES. THE PART OF THE OMENTUM THAT WAS SEALED WITH THE ORIGINAL DEVICE WAS OOZING AND SURGICEL POWDER WAS USED TO CONTROL THE BLEEDING. IT WAS THEN REPORTED THAT THE PATIENT WAS BROUGHT BACK TO THE OR TWO DAYS POST OP WITH SYMPTOMS OF BEING LIGHTHEADED, DIZZY, SHORTNESS OF BREATH AND NOT FEELING WELL. PATIENTS HEMOGLOBIN WAS TESTED AND WAS FOUND TO BE NOT NORMAL. A HEMATOMA WAS FOUND AT THE FAT PAD AROUND THE AREA WHERE THE DEVICE FAILED DURING THE ORIGINAL PROCEDURE. SURGEON USING A G2 ENSEAL REMOVED THE HEMATOMA. SURGEON THEN APPLIED VISTASEAL THEN SURGICEL POWDER ON TOP. PATIENT STATUS AS OF THE NEXT DAY IS DOING WELL AND HER NUMBERS GOOD.

  Patient problems: Dizziness; Hematoma; Insufficient Information

  MAUDE report 16459802 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE BARIATRIC PROCEDURE WITH AN ENSEAL DEVICE AND A COMPETITIVE STAPLER THAT THAT EVENING THE PHYSICIAN RECEIVED A CALL THAT THE PATIENT HAD TO BE OPERATED ON AGAIN DUE TO BLEEDING. NO OTHER INFORMATION COULD BE PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16381059 ↗
• InjuryDec 15, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT POST-OP TO THE SLEEVE GASTRECTOMY PROCEDURE, THE TEAM COORDINATOR STATED THEY HAD AN ENSEAL THAT ACCORDING TO THE DOCTOR, IT DID NOT SEAL VESSELS PROPERLY IN THE CASE. HE HAD TO BRING THE PATIENT BACK FOR BLEEDING TODAY. IT WAS UNKNOWN HOW THE CASE WAS COMPLETED AND IF THERE WERE ANY PATIENT CONSEQUENCES. NO OTHER DETAILS COULD BE PROVIDED AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15986611 ↗
• InjuryNov 22, 2022Activation, Positioning or Separation Problem; Difficult to Open or Close; No Apparent Adverse Event; Activation, Positioning or Separation Problem; Difficult to Open or Close; No Apparent Adverse Event

  IT WAS REPORTED THAT POST-OP TO THE SLEEVE GASTRECTOMY PROCEDURE, THE TEAM COORDINATOR STATED THEY HAD AN ENSEAL THAT ACCORDING TO THE DOCTOR, IT DID NOT SEAL VESSELS PROPERLY IN THE CASE. HE HAD TO BRING THE PATIENT BACK FOR BLEEDING TODAY. IT WAS UNKNOWN HOW THE CASE WAS COMPLETED AND IF THERE WERE ANY PATIENT CONSEQUENCES. NO OTHER DETAILS COULD BE PROVIDED AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15842837 ↗
• InjuryNov 2, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT A PATIENTS, WHO HAD A LAP GASTRIC SLEEVE SURGERY WITH THE DEVICE PREVIOUSLY HAD TO BE RE-ADMITTED DUE TO INTRA-ABDOMINAL HEMATOMA. THE PATIENT WAS READMITTED TO A DIFFERENT HOSPITAL AND WAS TREATED OVER THE COURSE OF A COUPLE OF DAYS, AND EVENTUALLY DISCHARGED. A COUPLE OF CT SCANS AND SOME OTHER THERAPIES WERE MENTIONED. THE BLEEDING MAY HAVE HAD OTHER ORIGINS, BUT IT IS SUSPECTED TO BE INADEQUATE SEALING ON THE PART OF THE DEVICE.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15714818 ↗
• InjuryNov 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST OP TO THE GASTRIC BYPASS PROCEDURE, THE NEXT DAY, THE PATIENT HAD A BLEED BY THE SMALL BOWEL AND MESENTERY AND THEY ALSO HAD A SMALL BLEED BY THE ABDOMINAL WALL. THE PATIENT HAD TO HAVE TWO BLOOD TRANSFUSIONS AND WAS DISCHARGED FIVE DAYS LATER. THE CT SCAN RULED OUT THAT THERE WAS LEAK. THE PATIENT IS NOW DOING WELL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15711240 ↗
• MalfunctionOct 14, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A GYN PROCEDURE THE JAWS OF THE DEVICE LOCKED ON TISSUE AND A HOOK HAD TO BE USED TO RELEASE. THERE WERE NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15606431 ↗
• MalfunctionOct 11, 2022Difficult to Open or Close; Difficult to Open or Close

  SEE ATTACHED MEDWATCH REPORT NUMBER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15577634 ↗
• MalfunctionAug 26, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE THAT THE METAL HINGE ON THE JAWS POPPED OUT BUT DID NOT DETACH AFTER THE SECOND ACTIVATION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15306245 ↗
• MalfunctionJun 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A BENIGN HYSTERECTOMY THE TIP OF THE SHAFT BROKE OFF. ALL FRAGMENTS WERE RETRIEVED AND A NEW DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14654281 ↗
• InjuryMay 11, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT POST OP TO THE UNKNOWN PROCEDURE, THE SURGEON HAD A PATIENT BRING BACK FROM A CASE ON (B)(6) 2022 THE FOLLOWING DAY DUE TO BLEEDING. THE SURGEON SAID HE WAS NOT SURE THE CAUSE OF THE BLEEDING THE PATIENT EXPERIENCED. THE SURGEON IRRIGATED THE ABDOMEN AND APPLIED VISTASEAL AS WELL AS ANOTHER HEMOSTASIS PRODUCT. LAST UPDATE, PATIENT WAS DOING OKAY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14360917 ↗