ETHIBOND EXCEL X588HRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031057692), received between Sep 28, 2021 and Dec 11, 2024 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR ARCH REPLACEMENT PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING CONTINUOUS SUTURING THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. THE SCRUB NURSE GRASPED THE NEEDLE WITH A NEEDLE HOLDER AND HANDED IT TO THE DOCTOR AND THE SUTURE WAS PULLED OUT WHEN THE NEEDLE WAS REMOVED BY GRASPING THE NEEDLE NEAR THE TIP OF THE NEEDLE AND PLACING THE SUTURE OVER THE LARGE ARTERY WITH CANNULATION POUCH SUTURE WITHOUT CHANGING THE NEEDLE. A NEW PACKAGE WAS USED AND THIS SAME EVENT OCCURRED TWICE IN A ROW. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20903869 ↗
• MalfunctionDec 11, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE HAD BEEN FRAYED WHEN THE SUTURE WAS TIED. 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 20903617 ↗
• MalfunctionDec 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR ARCH REPLACEMENT PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING CONTINUOUS SUTURING THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. THE SCRUB NURSE GRASPED THE NEEDLE WITH A NEEDLE HOLDER AND HANDED IT TO THE DOCTOR AND THE SUTURE WAS PULLED OUT WHEN THE NEEDLE WAS REMOVED BY GRASPING THE NEEDLE NEAR THE TIP OF THE NEEDLE AND PLACING THE SUTURE OVER THE LARGE ARTERY WITH CANNULATION POUCH SUTURE WITHOUT CHANGING THE NEEDLE. A NEW PACKAGE WAS USED AND THIS SAME EVENT OCCURRED TWICE IN A ROW. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20903340 ↗
• MalfunctionJul 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MITRAL VALVE REPAIR ON (B)(6)2024 AND SUTURE WAS USED. DURING A MITRAL VALVULOPLASTY: MVP, DURING CONTINUOUS SUTURING FOR THE MITRAL VALVE FORMATION, THE NEEDLE AND SUTURE HAD BEEN DETACHED EASILY. IT OCCURRED THAT 2 NEEDLE-SUTURES IN A ROW. NO PIECES FELL INTO THE PATIENT BECAUSE THE SUTURE WAS DETACHED DURING GRASPING THE DISCONNECTED NEEDLE. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. 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 19691779 ↗
• MalfunctionMar 27, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE SURGERY, THE NEEDLE WAS DETACHED FROM THE SUTURE DURING CONTINUOUS SUTURING. THIS ISSUE OCCURRED 3 TIMES IN A ROW DURING A SINGLE CASE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18985529 ↗
• MalfunctionMar 27, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE SURGERY, THE NEEDLE WAS DETACHED FROM THE SUTURE DURING CONTINUOUS SUTURING. THIS ISSUE OCCURRED 3 TIMES IN A ROW DURING A SINGLE CASE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18985527 ↗
• MalfunctionMar 27, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE SURGERY, THE NEEDLE WAS DETACHED FROM THE SUTURE DURING CONTINUOUS SUTURING. THIS ISSUE OCCURRED 3 TIMES IN A ROW DURING A SINGLE CASE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18985526 ↗
• MalfunctionSep 28, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS TO BE USED. DURING THE PROCEDURE, A HAIR WAS NOTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12542519 ↗

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.