ETHIBOND EXCEL X832HRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031058019), received between Jul 11, 2019 and Sep 11, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WILL ATTEMPT TO OBTAIN SAMPLES. THE SURGEON USED IT AND AGAIN EASILY BROKE WHEN BEING KNOTTED. ADDITIONAL INFORMATION HAVE BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23028605 ↗
• MalfunctionAug 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE OPERATION THE NEEDLE PULLED OFF FROM THE THREAD. SHE REMAINED HUNG INSIDE THE TROCAR AND FORTUNATELY, BUT REMAINED FOR A WHILE UNTRACEABLE. RESULTING IN WASTED TIME LOOKING FOR THE NEEDLE WHEN THE THREAD PULLED OFF AND LONGER INTERVENTION TIME. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22701182 ↗
• MalfunctionJun 28, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. ONE SUTURE BROKE AT USAGE. A SECOND SUTURE BROKE BEFORE BEING USED. THE SURGEON ASKED FOR THE ENTIRE BOX TO BE REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19633097 ↗
• MalfunctionDec 29, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THAT DURING A PROCEDURE, THE DOCTOR HAD A SUTURE SWEDGE DURING A CASE TODAY. THE DOCTOR USED A COUPLE MORE OF THESE AND DID NOT HAVE A PROBLEM. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18418915 ↗
• MalfunctionJul 11, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT FINGER CARPOMETACARPAL REPLACEMENT, TRIGGER RELEASE PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. AS THE SURGEON TRIED TO TIE THE SUTURE, IT BROKE OFF FROM THE NEEDLE. THERE WAS A SLIGHT DELAY IN SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8782564 ↗
• MalfunctionJul 11, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT FINGER CARPOMETACARPAL REPLACEMENT, TRIGGER RELEASE PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. AS THE SURGEON TRIED TO TIE THE SUTURE, IT BROKE OFF FROM THE NEEDLE. THERE WAS A SLIGHT DELAY IN SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8782560 ↗

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.