NOVOSTITCH CTX-R001Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00853541006105), received between Jul 11, 2020 and May 28, 2026 — classified as 12 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, NOVOSTITCH SUTURE BROKE AFTER THE DEPLOYMENT. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25318425 ↗
• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT, DURING A SURGERY, THE NOVOSTITCH SUTURE BROKE AFTER DEPLOYMENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25311332 ↗
• MalfunctionJul 30, 2025Break; Break

  IT WAS REPORTED THAT, DURING A RADIUS MENISCUS TEAR REPAIR, THE SURGEON TIED THE KNOT AND REPAIRED THE MENISCUS TEAR BUT AFTER A WHILE THE NOVOSTITCH CARTRIDGE 2-0 SUTURE BROKE, AND THE REPAIR SITE WAS OPENED AGAIN. THE SUTURE WAS REMOVED FROM THE PATIENT WITH A GRASPER. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22669071 ↗
• MalfunctionJun 30, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A REPAIR OF A RADIAL TEAR OF THE MENISCUS, AFTER PASSING THE FIRST SUTURE, RELOADING AND PASSING HIS SECOND SUTURE, THE GUN OF THE NOVOSTITCH SEEMED TO JAM ON THE MENISCUS. WHEN THE GUN FINALLY RELEASED, A PIECE OF NEEDLE WAS LEFT BEHIND IN THE MENISCUS. THE BROKEN FRAGMENT WAS REMOVED FROM INSIDE THE PATIENT WITH GRASPERS AND THE MENISCAL REPAIR WAS COMPLETED WITH ALL INSIDE DEVICES. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22366603 ↗
• MalfunctionMay 15, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING A POSTERIOR MENISCUS REPAIR PROCEDURE, THE NOVOSTITCH CARTRIDGE 2-0 FIRST PIERCING WAS SUCCESSFUL, HOWEVER, THE SECOND PIERCING WAS NOT SUCCESSFUL, AND IT STUCK IN BETWEEN. IT WAS REMOVED FROM THE PATIENT USING A GRASPER AND AN ARTERY. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22027320 ↗
• MalfunctionDec 16, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE SUTURE BROKE WHILE TENSIONING IT USING NOVOSTITCH CARTRIDGE. THE SUTURE WAS CUT WITH SISCORS AND PULLED OUT FROM THE PATIENT. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20939080 ↗
• MalfunctionMay 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A RADIAL MENISCAL REPAIR THE CARTRIDGE OF THE NOVOSTITCH 2-0 COULD NOT LOAD CORRECTLY INTO THE NOVOSTITCH, THE NURSE TRIED NUMEROUS TIMES WITH MY GUIDANCE. EVENTUALLY THE NEEDLE FELL OUT, RESULTING IN THE CARTRIDGE BEING DISCARDED AND A NEW ONE OPENED THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17005334 ↗
• InjuryFeb 15, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR PROCEDURE, THE SUTURE OF THE NOVOSTITCH CARTRIDGE COULD NOT BE RELEASED FROM THE NOVOSTITCH PRO WHEN THE RATCHET WAS SQUEEZED. SURGERY WAS COMPLETED AFTER A 45-MINUTE DELAY, BY CHANGING TO AN ALL INSIDE-OUT TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16378724 ↗
• MalfunctionMay 30, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A MENISCUS RADIAL TEAR REPAIR USING A NOVOSTITCH, WHEN PRESSING THE LOWER JAW LEVER TOGETHER WITH THE UPPER JAW LEVER, THE NEEDLE WAS NOT ABLE TO PUNCH THROUGH THE MENISCUS TISSUE, THE SUTURE WAS STUCK AT THE RADIUSES UPPER JAW. ON THE SECOND ATTEMPT TO TRIGGER, THE NEEDLE GOT STUCK AND COULD NOT COME OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14543266 ↗
• MalfunctionApr 12, 2022Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR PROCEDURE, THE NOVOSTITCH REPLACEMENT CARTRIDGE HAD A FAILURE, THE SUTURE BUNCHED IN THE MECHANISM AND FAILED TO FIRE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING THE S+N MENISCAL STITCHER INSTEAD. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14083890 ↗
• InjuryMar 14, 2022Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE NEEDLE OF THE NOVOSTITCH CARTRIDGE WAS BENT AND CAUSED THE SUTURE COULD NOT PASS THROUGH THE MENISCUS. PROCEDURE FINISHED WITH S/N BACKUP DEVICE. NO SURGICAL DELAY OR INJURY TO PATIENT REPORTED DUE THIS EVENT. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THE DISTAL TIP OF THE SHAFT (LOWER JAW) OF THIS UNIT WAS DETACHED WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13754202 ↗
• InjuryMar 10, 2022Break; Firing Problem; Break; Firing Problem

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR SURGERY, INTERNAL TO THE PATIENT, THE NEEDLE OF THE NOVOSTITCH DID NOT COME OUT OF THE LOWER JAW ON DEPLOYING THE CARTRIDGE. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. PRELIMINARY RESULTS OF INVESTIGATION HAD CONCLUDED THAT THE TIP OF THE NEEDLE WAS PHYSICALLY BROKEN AND WOULD NOT RETRACT ONCE ACTUATED WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13717572 ↗
• InjuryMar 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A KNEE SURGERY, A FRESH '2-0 CARTRIDGE' WAS LOADED ONTO THE 'NOVOSTITCH HANDLE' AND ADVANCED INTO THE KNEE JOINT; UPON VISUALIZATION IT APPEARED A SMALL CURVED PIECE HAD PEELED OFF THE TIP OF THE CARTRIDGE. WHEN TRYING TO REMOVE THE CARTRIDGE FROM THE KNEE, THIS PIECE CAME LOOSE. THE PIECE WAS RETRIEVED WITH AN ARTHROSCOPIC GRASPER. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE. A SIGNIFICANT DELAY GREATER THAN 60MIN TOOK PLACE, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13654723 ↗
• MalfunctionSep 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A LEFT KNEE LATERAL MENISCUS RADIAL TEAR REPAIR, USING NOVOSTITCH PRO, WHEN USING THE FORTH CARTRIDGE, THE UPPER JAW WAS NOT ARTICULATING PROPERLY. ON CLOSER INSPECTION, THE SMALL LEVER TO CONTROL THE MOVEMENT OF THE UPPER JAW HAD DETACHED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING AN S+N BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12426062 ↗
• MalfunctionAug 20, 2021Device Dislodged or Dislocated; Mechanical Jam; Device Dislodged or Dislocated; Mechanical Jam

  IT WAS REPORTED THAT DURING USE IN AN UNKNOWN PROCEDURE, THE NEEDLE OF THE NOVOSTITCH WAS STUCK, THE SUTURE COULD NOT HOLD IN THE MENISCUS AND CAME OUT. A DELAY LESS OR EQUAL THAN 30 MINUTES WERE REPORTED AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12348365 ↗
• InjuryMar 14, 2021Failure to Cycle; Failure to Cycle

  IT WAS REPORTED THAT DURING SURGERY, THE SUTURE OF THE NOVOSTITCH CARTRIDGE DROPPED FROM THE UPPER JAW WHERE THE SUTURE PULLS OUT OF THE MENISCUS. THE SUTURE WAS RETRIEVED BY USING GRASPER. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR OTHER COMPLICATIONS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478741 ↗
• InjuryJan 7, 2021Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY, BOTH PRE-LOADED AND THE FIRST RELOADING CARTRIDGE HAD NO PROBLEMS PLACING THE SUTURE. THE OTHER RELOADING CARTRIDGE WAS PROPERLY INSERTED AND PLACED IN THE JOINT. WHEN ACTUATING THE UPPER JAW WITH THE ORANGE HANDLE, A SMALL METAL PART CAME LOOSE. IT WAS NOT POSSIBLE TO IDENTIFY IF THE METAL PIECE WAS FROM THE INSTRUMENT OR THE RE-LOADING CARTRIDGE. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT¿S ANATOMY. NO DELAY OR OTHER COMPLICATIONS WERE REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11132615 ↗
• InjuryNov 4, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE NOVOSTICH BROKE WHILE KNOTTING, SUTURE WAS REMOVED WITH GRASPERS; THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10784668 ↗
• InjuryOct 27, 2020Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR SURGERY, THE TIP OF THE CARTRIDGE BROKE OFF IN THE KNEE JOINT. NO BROKEN PIECES WERE LEFT IN THE PATIENT BUT IT IS UNKNOWN HOW THEY WERE REMOVED. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO INFORMATION ABOUT SURGICAL DELAY WAS PROVIDED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 10744469 ↗
• InjurySep 15, 2020Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY, THE TIP OF THE NOVOSTITCH CARTRIDGE BROKE INSIDE THE PATIENT'S KNEE JOINT. ALL PIECES WERE REMOVED USING ARTHROSCOPIC GRASPERS. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10534512 ↗
• InjuryAug 21, 2020Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY THE NOVOSTITCH PRO NEEDLE BROKE OFF INSIDE THE PATIENT'S KNEE. ALL THE BROKEN PIECES WERE REMOVED FROM THE JOINT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY OR IF THERE WAS A BACK-UP DEVICE AVAILABLE TO COMPLETE THE PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10440316 ↗
• InjuryAug 13, 2020Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A KNEE SCOPE AND MENISCUS REPAIR, THE NEEDLE OF THE CARTRIDGE GOT STUCK ON THE NOVOSTITCH PRO REPAIR SYSTEM AND COULDN¿T DEPLOY THE SECOND TIME. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO SIGNIFICANT DELAY OR FURTHER COMPLICATIONS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10401083 ↗
• InjuryJul 11, 2020Break; Break

  IT WAS REPORTED THAT THE NOVOSTITCH CARTRIDGE BROKE OFF IN THE PATIENT, LEAVING A METAL PIECE INSIDE OF HIS ANATOMY. INCIDENT OCCURRED AFTER THE PROCEDURE, WHEN A SCAN WAS PERFORMED ON THE PATIENT, SHOWING THE METAL PIECE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE AND THERE WAS NO DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10261825 ↗