SmartBand SafeGrip Multi-Band Ligation Kit SLK-6-LFRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00850261006033), received between May 3, 2019 and Oct 22, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2025Mechanical Problem; Mechanical Problem

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THE BANDS DID NOT DEPLOY PROPERLY FROM THEIR SMARTBAND DEVICE. NO REPORT OF INJURY.

  Patient problems: Insufficient Information

  MAUDE report 23360365 ↗
• MalfunctionOct 22, 2025Mechanical Problem; Insufficient Device Problem Information; Mechanical Problem; Insufficient Device Problem Information

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE USER FACILITY THAT WHILE USING THE SMARTBAND MULTI-BAND LIGATION KIT "THE ELASTIC LIGATURE WAS REJECTED DUE TO THE STRING FRAYING DURING THE TRACTION OF THE FIRST BAND. FURTHERMORE, ON THE THIRD BAND, THE STRING RUPTURED THE ASPIRATED VARICOSE VEIN."

  Patient problems: Insufficient Information; Rupture

  MAUDE report 23360357 ↗
• MalfunctionSep 13, 2023Material Twisted/Bent; Material Twisted/Bent

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE BANDING STRING FROM THEIR MULTI-BAND LIGATION KIT BECAME KNOTTED RESULTING IN A PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17739587 ↗
• MalfunctionSep 13, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT THE BAND COMPONENTS OF THEIR SMARTBAND SAFE GRIP MULTI-BAND LIGATION KIT WOULD NOT SEPARATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY; HOWEVER, A PROCEDURAL DELAY WAS REPORTED AS THE FACILITY HAD TO USE ANOTHER DEVICE BEFORE CONTINUING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17739304 ↗
• MalfunctionDec 1, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DISTRIBUTOR REPORTED THAT DURING A PATIENT PROCEDURE USER FACILITY PERSONNEL WERE TREATING ESOPHAGEAL VARICES BY PLACING SIX ELASTIC LIGATION BANDS. THE USER OBSERVED BLEEDING IN THE PATIENT WHICH RESULTED IN A BLOOD TRANSFUSION. THE USER FACILITY REPORTED THAT THE PATIENT IS FINE AND HAS SINCE RETURNED HOME.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 15898150 ↗
• MalfunctionDec 9, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE WHICH INCLUDED USE OF THEIR SMARTBAND MULTI-BAND LIGATION SYSTEM AN AREA OF BLEEDING IN THE PATIENT'S THROAT WAS NOTED. NO MEDICAL INTERVENTION WAS ADMINISTERED. THE PATIENT IS REPORTED TO BE DOING FINE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY UTILIZING THE LIGATION SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12967383 ↗
• MalfunctionAug 7, 2019Break; Detachment of Device or Device Component

  BAND FELL OFF OF ESOPHAGEAL VARICES AFTER IT WAS DEPLOYED. THE PATIENT WAS BROUGHT TO THE ENDOSCOPY ROOM WHERE THE PROCEDURES WERE BEING DONE TODAY. ANESTHESIA WAS ADMINISTERED AND WELL TOLERATED. THE PATIENT WAS PLACED IN THE LEFT LATERAL DECUBITUS POSITION. INSPECTION OF THE HYPOPHARYNX SHOWED NORMAL VOCAL CORDS WITHOUT REFLUX INJURY OR NEOPLASM. THE VIDEO GASTROSCOPE WAS INTRODUCED INTO THE ESOPHAGUS, STOMACH, AND DUODENUM WITH THE FOLLOWING FINDINGS: THE SECOND AND THIRD PORTION OF THE DUODENUM WERE NORMAL AND THE PAPILLA OF VATER WAS SEEN. STOMACH HAD COBBLE STONING AND ERYTHEMA. RETROFLEXED VIEW SHOWS NO OTHER ABNORMALITY. THE SQUAMOCOLUMNAR JUNCTION WAS AT APPROXIMATELY 40 CM. THE ESOPHAGUS HAD 4 COLUMNS OF MID GRADE VARICES. 6 BANDS WERE DEPLOYED, ONE SLIPPED OFF AND A SECOND SET WAS USED TO REPLACE THAT BAND. THE SCOPE WAS SLOWLY WITHDRAWN WHILE SUCTIONING AIR AND FLUID. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: Erythema; Foreign Body In Patient

  MAUDE report 8869311 ↗
• MalfunctionJun 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE SERVICE CENTER RECEIVED A USER FACILITY MEDWATCH FORM THAT REPORTS NEAR THE END OF A HB ESOPHAGOGASTRODUODENOSCOPY WITH VARICEAL BAND LIGATION PROCEDURE, THE BAND MISFIRED ON ITS OWN AND FELL INTO THE PATIENT¿S ESOPHAGOGASTRIC JUNCTION (EGJ). THE SCOPE WAS SLOWLY WITHDRAWN WHILE SUCTIONING AIR AND FLUID. THE PATIENT TOLERATED THE PROCEDURE WELL. IT WAS REPORTED THAT PRIOR TO THE INCIDENT THE SURGEON HAD INTRODUCED THE VIDEO GASTROSCOPE INTO THE PATIENT¿S ESOPHAGUS, STOMACH AND DUODENUM AND OBSERVED THE FOLLOWING FINDINGS: THE SECOND AND THIRD PORTION OF THE DUODENUM AND DUODENAL BULB WERE NORMAL AND THE PAPILLA OF VATER WAS SEEN. THE PYLORUS WAS PATENT. THE PATIENT¿S STOMACH HAD COBBLESTONING OF THE MUCOSA. THE RETROFLEXED VIEW SHOWED NO OTHER ABNORMALITIES. IN ADDITION, THE PATIENT¿S SQUAMOCOLUMNAR JUNCTION WAS APPROXIMATELY AT 38CM WITH A NODULAR INFLAMED AREA AS WELL AS SCARS AND ULCERS NOTED ON THE ESOPHAGUS WHICH WERE LIKELY ATTRIBUTED TO PREVIOUS BANDING. THE ESOPHAGUS HAD SCARS AND ULCERS FROM PREVIOUS BANDING AND 2 COLUMNS OF VARICES THAT WERE BANDED X 4.

  Patient problems: Foreign Body In Patient

  MAUDE report 8686369 ↗
• MalfunctionMay 3, 2019Misfire

  BANDER MALFUNCTION. BANDER MISFIRED ON THE WAY OUT OF ESOPHAGUS ON ITS OWN. PROCEDURAL NOTE: PATIENT WHO PRESENTS TO ENDOSCOPY FOR EGD TO EVALUATE VARICES LAST BANDED EARLIER THIS YEAR. PROCEDURE PERFORMED: HB ESOPHAGOGASTRODUODENOSCOPY WITH VARICEAL BAND LIGATION. THE VIDEO GASTROSCOPE WAS INTRODUCED INTO THE ESOPHAGUS, STOMACH, AND DUODENUM WITH THE FOLLOWING FINDINGS: THE SECOND AND THIRD PORTION OF THE DUODENUM WERE NORMAL AND THE PAPILLA OF VATER WAS SEEN. DUODENAL BULB WAS NORMAL. THE PYLORUS WAS PATENT. STOMACH HAD COBBLESTONING OF THE MUCOSA. RETROFLEXED VIEW SHOWS NO OTHER ABNORMALITY. THE SQUAMOCOLUMNAR JUNCTION WAS AT APPROXIMATELY 38 CM WITH A NODULAR INFLAMED AREA, LIKELY PREVIOUS BANDING. THE ESOPHAGUS HAD SCARS AND ULCERS FROM PREVIOUS BANDING A 2 COLUMNS OF VARICES THAT WERE BANDED X4. ONE BAND WENT INTO THE EGJ AREA. THE SCOPE WAS SLOWLY WITHDRAWN WHILE SUCTIONING AIR AND FLUID. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8577305 ↗