ETHIBOND EXCEL MX553Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705031047136), received between Jan 31, 2023 and Jun 14, 2024 — classified as 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT (AVR) PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING SURGERY, THE SUTURE HAD BEEN DETACHED EASILY FROM THE SWAGE PART. IT WAS NOT A CONTROL RELEASE NEEDLE. THE PRODUCT WAS USED FOR BLOOD REMOVAL OF THE CARDIOPULMONARY BYPASS. THE OPERATION WAS FINISHED WITHOUT PROBLEM WITH THE USE OF ANOTHER PACKAGE. THE PRODUCT WAS USED ON THE DEVASCULARIZATION SUTURING. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19537645 ↗
• MalfunctionJun 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT (AVR) PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING SURGERY, THE SUTURE HAD BEEN DETACHED EASILY FROM THE SWAGE PART. IT WAS NOT A CONTROL RELEASE NEEDLE. THE PRODUCT WAS USED FOR BLOOD REMOVAL OF THE CARDIOPULMONARY BYPASS. THE OPERATION WAS FINISHED WITHOUT PROBLEM WITH THE USE OF ANOTHER PACKAGE. THE PRODUCT WAS USED ON THE DEVASCULARIZATION SUTURING. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19537624 ↗
• MalfunctionJun 13, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A CARDIAC VALVULOPLASTY ON (B)(6) 2024 AND A SUTURE WAS USED. DURING INTERRUPTED SUTURE, WHEN TRIED TO USE, NEEDLE HAD BEEN DETACHED AT THE SWAGE. THE OPERATION WAS FINISHED WITHOUT PROBLEM BECAUSE ANOTHER PACKAGE USED. THE OPERATION TIME WAS NOT EXTENDED. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19531288 ↗
• MalfunctionJun 13, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A CARDIAC VALVULOPLASTY ON (B)(6) 2024 AND A SUTURE WAS USED. DURING INTERRUPTED SUTURE, WHEN TRIED TO USE, NEEDLE HAD BEEN DETACHED AT THE SWAGE. THE OPERATION WAS FINISHED WITHOUT PROBLEM BECAUSE ANOTHER PACKAGE USED. THE OPERATION TIME WAS NOT EXTENDED. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19531282 ↗
• MalfunctionMay 23, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE CARDIOVASCULAR PROCEDURE, WHEN A NURSE TRIED TO INSTALL THE PLEDGET, THE NEEDLE WAS EASILY DETACHED FROM THE SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16984719 ↗
• MalfunctionMay 23, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE CARDIOVASCULAR PROCEDURE, WHEN A NURSE TRIED TO INSTALL THE PLEDGET, THE NEEDLE WAS EASILY DETACHED FROM THE SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16984656 ↗
• MalfunctionJan 31, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT BY A CORONARY ARTERY BYPASS GRAFT PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE HAD BROKEN REPEATEDLY DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16273838 ↗
• MalfunctionJan 31, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT BY A CORONARY ARTERY BYPASS GRAFT PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE HAD BROKEN REPEATEDLY DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16272749 ↗
• MalfunctionJan 31, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT BY A CORONARY ARTERY BYPASS GRAFT PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE HAD BROKEN REPEATEDLY DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16272743 ↗
• MalfunctionJan 31, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT BY A CORONARY ARTERY BYPASS GRAFT PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE HAD BROKEN REPEATEDLY DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16272734 ↗

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.