ETHIBOND EXCEL X833HRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031058033), received between Feb 21, 2018 and Sep 4, 2024 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2024Component Missing; Component Misassembled; Component Missing; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY SALES REP THAT THE OR TEAM OPENED A PACK OF X833H AND THERE HAS BEEN TWO EACHES THAT WERE DOUBLE ARMED WHEN THEY WERE SUPPOSED TO BE SINGLE ARMED. THERE WAS NO PATIENT INVOLVEMENT. DEVICE AVAILABILITY UNKNOWN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20137518 ↗
• MalfunctionSep 4, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY SALES REP THAT THE OR TEAM OPENED A PACK OF X833H AND THERE HAS BEEN TWO EACHES THAT WERE DOUBLE ARMED WHEN THEY WERE SUPPOSED TO BE SINGLE ARMED. THERE WAS NO PATIENT INVOLVEMENT. DEVICE AVAILABILITY UNKNOWN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20137489 ↗
• MalfunctionJun 7, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE UPPER GI SURGEON WAS USING 2-0 ETHIBOND TO SUTURE MESENTERY, AND THE NEEDLE CAME AWAY FOR THE THREAD DURING SURGERY. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19484298 ↗
• MalfunctionJun 6, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE UPPER GI SURGEON WAS USING 2-0 ETHIBOND TO SUTURE MESENTERY, AND THE NEEDLE CAME AWAY FOR THE THREAD DURING SURGERY. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19477471 ↗
• MalfunctionApr 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE SURGERY, THE NEEDLE AND SUTURE HAD COME OFF EASILY DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19164731 ↗
• MalfunctionDec 20, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED WOUND CLOSURE PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16015930 ↗
• InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NISSEN FUNDOPLICATION WITH A HIATAL HERNIA REPAIR ON (B)(6) 2016 AND SUTURE WAS USED. THE PATIENT REPORTED EXPERIENCING PROBLEMS FOR THE LAST SIX YEARS AND REPORTED THAT THE MESH WAS IMPLANTED WHERE THE SUTURE AND CLIPS WERE USED. THE PATIENT REPORTED EXPERIENCING BLOOD CLOTS THREE TIMES AS WELL AS LARGE BOWEL OBSTRUCTION THAT WAS RECENTLY FIXED. SHE STATED THAT THE SURGEON KNEW THAT THIS WAS HER LAST OPTION AND BECAUSE OF THAT, THE SURGEON DECIDED TO PUT IN EXTRA HARDWARE TO HOLD THE STOMACH IN PLACE, BUT IT DID NOT WORK. THE PATIENT IS EXPERIENCING "SEAR GRIEF" AS A RESULT AND STATED SHE HAS HAD TO WAIT NINE MONTHS TO FIND ANOTHER SURGEON. ADDITIONALLY, THE PATIENT REPORTED HAVING TO HAVE A PARTIAL GASTRECTOMY ON AN UNKNOWN DATE BECAUSE OF ALL THE EXTRA HARDWARE AND IT "SCREWED UP HER STOMACH". AFTER THAT PROCEDURE, THE PATIENT HAD MORE COMPLICATIONS WITH BLOOD CLOTS. THE PATIENT WAS TREATED WITH SAVAYAS FOR THE CLOTTING. THE PATIENT EXPERIENCED THE SEVEN-MILLIMETER BOWEL OBSTRUCTION IN 2020. THE PATIENT REPORTED UNDERGOING AN UNKNOWN SURGERY FOR SOMETHING ELSE IN (B)(6) 2020 AND ENDED UP HAVING BLOOD CLOTS AGAIN. THIS YEAR SHE HAS HAD T

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Loss of consciousness; Obstruction/Occlusion; Pain; Vomiting

  MAUDE report 11832173 ↗
• MalfunctionFeb 1, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE DURING USE IN THE PATIENT¿S BODY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11259303 ↗
• MalfunctionAug 18, 2020Material Frayed; Material Separation; Material Frayed; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BARIATRIC PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE EASILY POPPED OFF THE SUTURE AT THE SWAGE. THE SUTURE WOULD ALSO EASILY FRAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10423686 ↗
• MalfunctionJul 26, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE IT WAS NOTICED THAT THE TIP OF THE SUTURE NEEDLE WAS MISSING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7725026 ↗
• MalfunctionFeb 21, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INCISIONAL HERNIA PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF. THE SURGEON HAD TO DIG IN THE PATIENT'S TISSUE TO RETRIEVE SOME OF THEM. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7287855 ↗

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-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-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-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.