ETHIBOND EXCEL SX54HRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031050587), received between Feb 9, 2018 and Jun 13, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Component Incompatible” (3 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.

• MalfunctionJun 13, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. THE FIXATION FEATURE BROKE DURING THE SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17116702 ↗
• MalfunctionOct 14, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DERMAL GLANDULAR BREAST MASTOPEXY ON (B)(6) 2010 AND SUTURE WAS USED. DURING THE PROCEDURE, THE DEVICE WAS VERY FRIABLE AT THE NEEDLE TO STITCH INTERFACE. THE DEVICE EASILY PULLED OFF STITCH FROM THE NEEDLE. THE BROKEN PIECE WAS NOT REMOVED. THE SURGERY WAS DELAYED 45 MINUTES. THE CONDITION OF THE PATIENT WAS REPORTED AS EXCELLENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 10677831 ↗
• MalfunctionJun 17, 2020Component Incompatible; Component Incompatible

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VALVE REPLACEMENT PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS NOTED THAT THE PLEDGET IN THE SUTURE WAS NOT IN THE EXACT SIZE AS PER THE DESCRIPTION. THE SURGEON DID NOT USE THE DEVICE AFTER IT WAS OPENED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10162176 ↗
• MalfunctionJun 17, 2020Component Incompatible; Component Incompatible

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VALVE REPLACEMENT PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS NOTED THAT THE PLEDGET IN THE SUTURE WAS NOT IN THE EXACT SIZE AS PER THE DESCRIPTION. THE SURGEON DID NOT USE THE DEVICE AFTER IT WAS OPENED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10162175 ↗
• MalfunctionJun 17, 2020Component Incompatible; Component Incompatible

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VALVE REPLACEMENT PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS NOTED THAT THE PLEDGET IN THE SUTURE WAS NOT IN THE EXACT SIZE AS PER THE DESCRIPTION. THE SURGEON DID NOT USE THE DEVICE AFTER IT WAS OPENED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10162174 ↗
• MalfunctionFeb 9, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CABG AND VALVE REPLACEMENT PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. THE NEEDLE SEPARATED FROM THE NEEDLE DURING USE. NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7260863 ↗

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.