OverStitch NXT Endoscopic Suturing SystemRecalls & reported problems across all models
Apollo Endosurgery, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 35
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls
- 0
We found 2 models of OverStitch NXT Endoscopic Suturing System by Apollo Endosurgery, Inc. in the FDA's device registry (GUDID). Together they are named in 35 adverse event reports in the FDA's MAUDE database, received between Mar 18, 2024 and Jul 31, 2026 — classified as 10 injuries, 25 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (15 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported OverStitch NXT Endoscopic Suturing System problems
Device problems
- Device-Device Incompatibility15
- Adverse Event Without Identified Device or Use Problem10
- Detachment of Device or Device Component7
- Material Twisted/Bent7
- Failure to Align4
- Difficult to Advance3
- Entrapment of Device3
- Device Slipped2
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- Perforation3
- Hemorrhage/Blood Loss/Bleeding2
- Laceration(s)2
- Abdominal Pain1
- Perforation of Esophagus1
OverStitch NXT Endoscopic Suturing System models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OverStitch NXT Endoscopic Suturing System ESS-G02-NXTEndoscopic Tissue Approximation Device31 reports
- OverStitch NXT Endoscopic Suturing System ESS-ESG-NXTEndoscopic Tissue Approximation Device4 reports
Recent OverStitch NXT Endoscopic Suturing System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 31, 2026Device-Device Incompatibility; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50094779 ↗InjuryJul 27, 2026Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
It was reported to Boston Scientific Corporation that an OverStitch NXT was used in the stomach during an Endoscopic Sleeve Gastroplasty (ESG) procedure on (b)(6)2026. During the procedure, after several sutures had been placed, one of the catheters on the OverStitch NXT device detached from the device distal end. To remove the device, the placed sutures were cut using Ensizor scissors, and the device was removed along with the endoscope. A new OverStitch NXT device was prepared and used to successfully complete the procedure as intended. The event prolonged the procedure by approximately 20 minutes. There was no patient complications reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50000545 ↗MalfunctionMar 16, 2026Device-Device Incompatibility; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM WAS USED DURING A TRANSORAL OUTLET REDUCTION (TORE) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE ANCHOR WOULD NOT STAY ON THE NEEDLE BODY. THE PROCEDURE WAS COMPLETED WITH A NEW OVERSTITCH DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24608296 ↗MalfunctionFeb 26, 2026Break; Device-Device Incompatibility
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, A PORTION OF THE ANCHOR EXCHANGE RELEASE HANDLE CAME APART FROM THE CATHETER. AS A RESULT, THE ANCHOR FAILED TO LOAD AND UNLOAD FROM THE NEEDLE SHAFT. THE PROCEDURE WAS COMPLETED WITH A NEW OVERSTITCH DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24458925 ↗MalfunctionFeb 10, 2026Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE IN THE STOMACH ON (B)(6) 2026. DURING THE PROCEDURE, THE ENDCAP DETACHED. THERE WAS AN ATTEMPT TO REATTACH THE ENDCAP, BUT IT DETACHED A SECOND TIME. THIS EVENT DELAYED THE PROCEDURE BY APPROXIMATELY 30 MINUTES. THE PROCEDURE WAS COMPLETED WITH A NEW OVERSTITCH DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24302699 ↗MalfunctionJan 8, 2026Material Twisted/Bent
NOTE: THIS IS THE SECOND OF TWO OVERSTITCH NXT DEVICES USED IN THE SAME PROCEDURE WITH TWO OVERSTITCH SUTURES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE SHAFT AND THE SUTURE ANCHOR BECAME BENT. THE SAME ISSUE OCCURRED WITH A SECOND OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM AND OVERSTITCH SUTURE. THE PROCEDURE WAS COMPLETED USING A NEW OVERSTITCH NXT DEVICE AND A NEW SUTURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24009451 ↗MalfunctionJan 6, 2026Material Twisted/Bent
NOTE: THIS IS THE FIRST OF TWO OVERSTITCH NXT DEVICES USED IN THE SAME PROCEDURE WITH TWO OVERSTITCH SUTURES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE SHAFT AND THE SUTURE ANCHOR BECAME BENT. THE SAME ISSUE OCCURRED WITH A SECOND OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM AND OVERSTITCH SUTURE. THE PROCEDURE WAS COMPLETED USING A NEW OVERSTITCH NXT DEVICE AND A NEW SUTURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23984294 ↗InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED. DURING WITHDRAWAL, A 4CM ESOPHAGEAL LACERATION WAS OBSERVED. THE LACERATION WAS REPAIRED USING AN X-TACK DEVICE. THE PATIENT WAS HOSPITALIZED FOR 4 DAYS FOLLOWING THE PROCEDURE. THERE WERE NO FURTHER COMPLICATIONS, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2025. POST-PROCEDURE, THE PATIENT DEVELOPED HOARSENESS AND REQUIRED VOCAL CORD REHABILITATION. NO ADDITIONAL SYMPTOMS HAVE BEEN OBSERVED AT THIS TIME.
Patient problems: Laceration(s)
MAUDE report 23743779 ↗MalfunctionDec 4, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM WAS USED DURING A PROCEDURE ON (B)(6) 2025. PRIOR TO THE PROCEDURE, IT WAS OBSERVED THAT THE NEEDLE SHAFT WAS BENT. THE PROCEDURE WAS COMPLETED WITH A NEW OVERSTITCH DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23722557 ↗MalfunctionNov 14, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM WAS USED DURING AN ESG PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE NEEDLE BODY WAS BENT, AND AS A RESULT, THE PHYSICIAN WAS UNABLE TO UNLOAD THE ANCHOR FROM THE NEEDLE BODY. THE PROCEDURE WAS COMPLETED WITH A NEW OVERSTITCH NXT DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23560207 ↗MalfunctionNov 12, 2025Device-Device Incompatibility; Material Integrity Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Device-Device Incompatibility; Material Integrity Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE ANCHOR EXCHANGE BECAME TWISTED. THE NEEDLE SHAFT WAS BENT AND WOULD NO LONGER RETRIEVE THE ANCHOR. THE PROCEDURE WAS DELAYED FOR APPROXIMATELY 30 MINUTES AND COMPLETED WITH A NEW OVERSTITCH DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23531540 ↗InjuryOct 27, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM WAS USED DURING AN EDG PROCEDURE ON OCTOBER 1, 2025. DURING THE PROCEDURE, THE PHYSICIAN PREPARED TO PLACE A SECOND SUTURE. TOO MUCH TISSUE WAS CAPTURED BY THE DEVICE AND THE ANCHOR EXCHANGE FAILED TO UNLOAD FROM THE NEEDLE BODY. WITH THE ANCHOR STILL IN THE PATIENT'S TISSUE, THE PHYSICIAN USED SCISSORS TO CUT THE SUTURE AND LEFT THE ANCHOR IN THE ESOPHAGEAL WALL. THE PROCEDURE WAS COMPLETED WITH MANTIS CLIPS TO FIXATE THE STENT. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23389928 ↗MalfunctionSep 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE AND AFTER THE FIRST SUTURE WAS COMPLETED, THE OVERSTITCH NXT TOWER SLID FORWARD AND WAS NO LONGER TOUCHING THE DISTAL END OF THE SCOPE. A NEW OVERSTITCH NXT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22954211 ↗MalfunctionAug 27, 2025Device Slipped; Detachment of Device or Device Component; Device Slipped; Detachment of Device or Device Component
IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN OVERSTITCH NXT FOR THE TREATMENT OF CLASS II OBESTITY DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE OVERSTITCH NXT LOOSENED FROM THE GASTROSCOPE AND COMPLETELY DETACHED AFTER THE THIRD SUTURE. THE ADHESIVE TAPES NO LONGER ADHERED TO THE GASTROSCOPE. THE ENDCAP DETACHED FROM THE OVERSTITCH DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OVERSTITCH NXT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22902019 ↗InjuryAug 22, 2025Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM WAS USED DURING A STENT SUTURING PROCEDURE ON (B)(6) 2025. DURING INSERTION, THE OVERSTITCH DEVICE COULD NOT BE ADVANCED INTO THE PATIENT'S ESOPHAGUS. THE PHYSICIAN ATTEMPTED A JAW THRUST AND APPLIED EXTRA LUBE TO THE DEVICE BUT WAS STILL UNSUCCESSFUL. THEN, THE PHYSICIAN ATTEMPTED TO USE AN OVERTUBE DEVICE AND SAW A PERFORATION IN THE PATIENT'S ESOPHAGUS BELIEVED TO BE CAUSED BY THE OVERSTITCH NXT AND ABORTED THE PROCEDURE. THE PATIENT WAS ADMITTED TO THE ICU. AFTER 3 NIGHTS IN THE HOSPITAL, THE PATIENT WAS DISCHARGED.
Patient problems: Perforation
MAUDE report 22872867 ↗
Other Apollo Endosurgery, Inc. products
All Apollo Endosurgery, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page