ETHIBOND EXCEL X834HRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10705031058064), received between Jul 9, 2018 and Aug 25, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Break” (22 reports).

8 other recalls cover devices cleared under the same FDA submission (K946173); they may or may not involve this specific model.

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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50442525 ↗
• MalfunctionAug 18, 2026Material Separation

  It was reported that a patient underwent a robot-assisted sacrocolpopexy procedure on (b)(6) 2026 and suture was used. During surgery, two of the four needles were detached from the sutures easily and fell into the abdominal cavity during needle retrieval. The situation was resolved after the respective needles were located and retrieved within approximately five minutes. The product was used on the mesh fixation site. It was not a control release needle. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50298809 ↗
• MalfunctionAug 18, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50298790 ↗
• MalfunctionApr 8, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE SURGEON WAS TYING THE SUTURE (CODE: X834), IT CAME APART IN A SHREDDING MANNER. THEY REMOVED THE SUTURE FROM THE FIELD AND PULLED ANOTHER (X834) SUTURE AND THE SAME ISSUE OCCURRED OF IT SHREDDING AND PULLING APART. THEY REMOVED THE SECOND SUTURE AND SWITCHED THE SUTURE TO A DIFFERENT KIND. BOTH SUTURES ARE FROM THE SAME LOT NUMBER. THE DEVICES WERE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24817234 ↗
• MalfunctionApr 8, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) /2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE SURGEON WAS TYING THE SUTURE (CODE: X834), IT CAME APART IN A SHREDDING MANNER. THEY REMOVED THE SUTURE FROM THE FIELD AND PULLED ANOTHER (X834) SUTURE AND THE SAME ISSUE OCCURRED OF IT SHREDDING AND PULLING APART. THEY REMOVED THE SECOND SUTURE AND SWITCHED THE SUTURE TO A DIFFERENT KIND. BOTH SUTURES ARE FROM THE SAME LOT NUMBER. THE DEVICES WERE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24817228 ↗
• MalfunctionNov 25, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UMBILICAL HERNIA REPAIR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN PASSING THE SUTURE THROUGH TISSUE, THE SUTURE BROKE. UNSURE OF THE TISSUE AT THE TIME OF ISSUE. ANOTHER LIKE DEVICE WAS USED. THERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649449 ↗
• MalfunctionJul 24, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE WAS BROKEN IN TWO PARTS IN THE BODY. THIS ISSUE HAPPENED TWO TIMES IN THE SAME SURGERY WITH THE SAME ITEM PRODUCT WITH THE SAME LOT NUMBER. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587621 ↗
• MalfunctionJul 24, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE WAS BROKEN IN TWO PARTS IN THE BODY. THIS ISSUE HAPPENED TWO TIMES IN THE SAME SURGERY WITH THE SAME ITEM PRODUCT WITH THE SAME LOT NUMBER. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587615 ↗
• MalfunctionJul 2, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROMONTOFIXATION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROMONTOFIXATION, THE NEEDLE WAS INTRODUCED WITH THE THREAD INTO THE PERITONEAL CAVITY. IT WAS USED VERY LITTLE, AND UPON REMOVAL, THE NEEDLE DETACHED FROM THE THREAD. THE OPERATOR WITHDREW THE BARE THREAD WITHOUT THE NEEDLE. ACTIVE SEARCH FOR THE NEEDLE IN THE INTRAPERITONEAL CAVITY: IT WAS QUICKLY FOUND AND EXTRACTED FROM THE PERITONEAL CAVITY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22385711 ↗
• MalfunctionJan 9, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EPITHELIALIZED TRACHEOSTOMY PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED FOR ANASTOMOSIS OF THE SKIN/TRACHEA. THE FOLLOWING EVENTS OCCURRED: BENDING OF NEEDLE DURING USE ¿ BREAKING OF NEEDLE DURING USE ¿ BLUNT NEEDLE ALREADY AFTER ONE SUTURE ¿ SNAPPING OF SUTURE DURING KNOTTING. THESE PROBLEMS WERE ONLY REPORTED WITH A SINGLE THREAD/NEEDLE. THERE WERE NO REPORTS OF OTHER CASES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18477741 ↗
• MalfunctionJul 10, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. AFTER REMOVAL OF THE PERICARDIAL DRAIN, THE DOCTOR WANTED TO PERFORM A STITCH USING THE DEVICE. WHEN MAKING THE STITCH, THE NEEDLE BROKE INTO 2 SEPARATE PARTS. ONE REMAINED ATTACHED TO THE THREAD AND THE OTHER REMAINED IN THE PATIENT, IT WAS RECOVERED WITH A KOCHER FORCEPS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17295644 ↗
• MalfunctionJan 24, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE NEEDLE BROKE IN 2 DURING THE STITCH (WITHOUT FORCING) AT THE JUNCTION 2/3 - 1/3 OF THE NEEDLE. THE NEEDLE WAS LOST INSIDE THE PATIENT BUT RETRIEVED AFTER WITHOUT DAMAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16236514 ↗
• MalfunctionApr 2, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. A FIRST NEEDLE BENDS WHEN PASSING OF A SOMEWHAT HARD SKIN LEVEL. THE SECOND BREAKAGE UNDER THE PATIENT'S SKIN: NECESSARY TO INCISE THE SKIN TO RECOVER IT RECURRENT PROBLEM WITH THIS MATERIAL WHICH REGULARLY REQUIRES THE USE OF SEVERAL DEVICES FOR THE SAME GESTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13992247 ↗
• MalfunctionApr 2, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2022 AND SUTURE WAS USED. A FIRST NEEDLE BENDS WHEN PASSING OF A SOMEWHAT HARD SKIN LEVEL. THE SECOND BREAKAGE UNDER THE PATIENT'S SKIN: NECESSARY TO INCISE THE SKIN TO RECOVER IT RECURRENT PROBLEM WITH THIS MATERIAL WHICH REGULARLY REQUIRES THE USE OF SEVERAL DEVICES FOR THE SAME GESTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13992245 ↗
• MalfunctionMar 9, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ARTERIOVENOUS FISTULA PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING A SKIN BURSA FOR CLOSURE OF AN ENTRY POINT OF AN ARTERIOVENOUS FISTULA, IT WAS NOTED THAT THE END OF THE NEEDLE BROKE WHILE MAKING A STITCH. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THIS INCIDENT CAUSED A RISK OF EXPOSURE TO BLOOD AND A RISK OF LOSING A NEEDLE TIP IN THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13712126 ↗
• MalfunctionDec 16, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CENTRAL LINE PLACEMENT PROCEDURE ON (B)(6), 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD WAS BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13018496 ↗
• MalfunctionOct 14, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN FIXATION OF A CATHETER ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE MAKING IT IMPOSSIBLE TO PENETRATE THE SKIN AT FIRST ATTEMPT TO STITCH. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12634532 ↗
• MalfunctionJul 30, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BILIARY DRAINAGE PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD PULLED OFF FROM THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12252813 ↗
• MalfunctionJul 30, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BILIARY DRAINAGE PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD PULLED OFF FROM THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12252812 ↗
• MalfunctionJul 7, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED FOR THE FIXATION OF A THORACIC DRAIN. DURING THE PROCEDURE, THE NEEDLE BROKE AFTER 2 STITCHES. USE OF ANOTHER NEEDLE TO PERFORM THE THIRD STITCH FOR THE FIXATION OF A THORACIC DRAIN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12131785 ↗
• MalfunctionJul 7, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE DURING THE PERFORMANCE OF AN ATTACHMENT POINT OF A CENTRAL VENOUS ROUTE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12131643 ↗
• MalfunctionJul 7, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED FOR A THORACIC DRAIN. DURING THE PROCEDURE, THE NEEDLE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12131496 ↗
• MalfunctionSep 9, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SVT ABLATION ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN TENSION WAS PUT ON THE SUTURE, IT RIPPED IN HALF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10511777 ↗
• MalfunctionSep 9, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SVT ABLATION ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN TENSION WAS PUT ON THE SUTURE, IT RIPPED IN HALF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10511687 ↗
• MalfunctionNov 27, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SLEEVE GASTRECTOMY ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED PERFORMING THE KNOT. ANOTHER LIKE DEVICE FROM A DIFFERENT LOT NUMBER WAS USED TO CONTINUE WITH THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8105762 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K946173. One submission often covers many models, so check the product and lot details in each record.

• Z-1516-2025 · Mar 7, 2025 · Open, Classified
  ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
• Z-1097-2025 · Dec 20, 2024 · Open, Classified
  PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovas
• Z-2486-2020 · Jun 10, 2020 · Open, Classified
  PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818 W819 W870
• Z-1841-2019 · Apr 19, 2019 · Terminated
  ETHIBOND EXCEL Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue app
• Z-1842-2019 · Apr 19, 2019 · Terminated
  ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue appr
• Z-0747-2019 · Dec 18, 2018 · Terminated
  PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated for use in general soft tissue approxima
• Z-1839-2015 · May 8, 2015 · Terminated
  Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutting, Lot #JD6163, Exp: July 2019. Fast ab
• Z-0492-2015 · Oct 17, 2014 · Terminated
  Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.