ETHIBOND EXCEL CX46DRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031024328), received between Aug 8, 2023 and Oct 26, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Separation” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE THE NEEDLE FELL OFF WITH OUT EFFORT. ANOTHER DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18016394 ↗
• MalfunctionOct 26, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE THE NEEDLE FELL OFF WITH OUT EFFORT. ANOTHER DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18016372 ↗
• MalfunctionAug 9, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON STATED THAT THE NEEDLE HAS BEEN POPPING OFF TOO EASILY. SURGEON WOULD PULL ANOTHER SUTURE TO CONTINUE WITH THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17495553 ↗
• MalfunctionAug 8, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HIATAL HERNIA REPAIR ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON STATED THAT THE NEEDLE HAS BEEN POPPING OFF TOO EASILY. SURGEON WOULD PULL ANOTHER SUTURE TO CONTINUE WITH THE PROCEDURE. IT HAPPENED SIX TIMES DURING THIS PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17483756 ↗
• MalfunctionAug 8, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HIATAL HERNIA REPAIR ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON STATED THAT THE NEEDLE HAS BEEN POPPING OFF TOO EASILY. SURGEON WOULD PULL ANOTHER SUTURE TO CONTINUE WITH THE PROCEDURE. IT HAPPENED SIX TIMES DURING THIS PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17483748 ↗
• MalfunctionAug 8, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HIATAL HERNIA REPAIR ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON STATED THAT THE NEEDLE HAS BEEN POPPING OFF TOO EASILY. SURGEON WOULD PULL ANOTHER SUTURE TO CONTINUE WITH THE PROCEDURE. IT HAPPENED SIX TIMES DURING THIS PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17483745 ↗
• MalfunctionAug 8, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HIATAL HERNIA REPAIR ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON STATED THAT THE NEEDLE HAS BEEN POPPING OFF TOO EASILY. SURGEON WOULD PULL ANOTHER SUTURE TO CONTINUE WITH THE PROCEDURE. IT HAPPENED SIX TIMES DURING THIS PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17483743 ↗
• MalfunctionAug 8, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HIATAL HERNIA REPAIR ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON STATED THAT THE NEEDLE HAS BEEN POPPING OFF TOO EASILY. SURGEON WOULD PULL ANOTHER SUTURE TO CONTINUE WITH THE PROCEDURE. IT HAPPENED SIX TIMES DURING THIS PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17483742 ↗
• MalfunctionAug 8, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HIATAL HERNIA REPAIR ON (B)(6)2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON STATED THAT THE NEEDLE HAS BEEN POPPING OFF TOO EASILY. SURGEON WOULD PULL ANOTHER SUTURE TO CONTINUE WITH THE PROCEDURE. IT HAPPENED SIX TIMES DURING THIS PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17483740 ↗

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.