ETHIBOND EXCEL X551HRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705031057531), received between Jul 7, 2022 and Jun 30, 2026 — classified as 17 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026. THE NEEDLE POPPED OFF OF THE SUTURE DURING USE. THERE HASN'T BEEN INJURY TO THE PATIENT BUT THEY HAVE HAD TO OPEN MORE SUTURE AND REDO SOME OF THE THINGS THEY WERE WORKING ON WITH IT. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25664465 ↗
• MalfunctionJun 30, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6)-2026. THE NEEDLE POPPED OFF OF THE SUTURE DURING USE. THERE HASN'T BEEN INJURY TO THE PATIENT BUT THEY HAVE HAD TO OPEN MORE SUTURE AND REDO SOME OF THE THINGS THEY WERE WORKING ON WITH IT. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25664464 ↗
• MalfunctionJun 30, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2026. THE NEEDLE POPPED OFF OF THE SUTURE DURING USE. THERE HASN'T BEEN INJURY TO THE PATIENT BUT THEY HAVE HAD TO OPEN MORE SUTURE AND REDO SOME OF THE THINGS THEY WERE WORKING ON WITH IT. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25664461 ↗
• MalfunctionMay 29, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN SURGEON USE X551H , NEEDLE ISOLATE FROM SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333157 ↗
• MalfunctionMay 1, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING UNKNOWN PROCEDURE IT WAS NOTED THAT THE SUTURE WAS SEALED INTO THE OUTER PACKAGING. AS A RESULT, THE SUTURE COULD NOT BE CONSIDERED STERILE AND WAS DEEMED UNUSABLE. NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25057326 ↗
• MalfunctionApr 13, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN THE SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865998 ↗
• MalfunctionOct 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS SUED. IT WAS REPORTED THAT THE NEEDLE IS POPPING OFF THE SWEDGE DURING A CARDIAC PROCEDURE WHEN THE SUTURE IS NOT SUPPOSED TO DO THAT. THE NEEDLE FELL INTO THE PATIENT, AND THEY RETRIEVED IT. THEY GOT ANOTHER SUTURE TO COMPLETE THE CASE WITHOUT PATIENT HARM. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20398459 ↗
• MalfunctionJan 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PEDIATRIC CARDIA PROCEDURE ON (B)(6) 2023, AND SUTURE WAS USED. THE SUTURE BREAKS FROM THE NEEDLE, WHEN THE SURGEON PENETRATE THE NEEDLE THROUGH THE TISSUE, IN THE SWAGE AREA. THE SURGERY WAS DELAYED ONE MINUTE DUE TO THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18467007 ↗
• MalfunctionJan 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PEDIATRIC CARDIA PROCEDURE ON (B)(6) 2023, AND SUTURE WAS USED. THE SUTURE BREAKS FROM THE NEEDLE, WHEN THE SURGEON PENETRATE THE NEEDLE THROUGH THE TISSUE, IN THE SWAGE AREA. THE SURGERY WAS DELAYED ONE MINUTE DUE TO THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18466992 ↗
• MalfunctionJan 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PEDIATRIC CARDIA PROCEDURE ON (B)(6) 2023, AND SUTURE WAS USED. THE SUTURE BREAKS FROM THE NEEDLE, WHEN THE SURGEON PENETRATE THE NEEDLE THROUGH THE TISSUE, IN THE SWAGE AREA. THE SURGERY WAS DELAYED ONE MINUTE DUE TO THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18466956 ↗
• MalfunctionJan 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN MYECTOMY PROCEDURE / MITRAL VALVE EVALUATION ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEONS WANT TO CANNULATE USING THE SUTURE, THE SUTURE BROKE AT THE SWAGE AREA, AND HAPPENED 3 TIMES. THE TOTAL SUTURES THAT BROKE IN THE SAME SPOT IS 3. IT WAS REPORTED THAT THE SURGERY WAS PROLONGED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18454389 ↗
• MalfunctionJan 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN MYECTOMY PROCEDURE / MITRAL VALVE EVALUATION ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEONS WANT TO CANNULATE USING THE SUTURE, THE SUTURE BROKE AT THE SWAGE AREA, AND HAPPENED 3 TIMES. THE TOTAL SUTURES THAT BROKE IN THE SAME SPOT IS 3. IT WAS REPORTED THAT THE SURGERY WAS PROLONGED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18453438 ↗
• MalfunctionJan 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN MYECTOMY PROCEDURE / MITRAL VALVE EVALUATION ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEONS WANT TO CANNULATE USING THE SUTURE, THE SUTURE BROKE AT THE SWAGE AREA, AND HAPPENED 3 TIMES. THE TOTAL SUTURES THAT BROKE IN THE SAME SPOT IS 3. IT WAS REPORTED THAT THE SURGERY WAS PROLONGED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18453251 ↗
• MalfunctionOct 2, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THE SUTURE IS EASILY BROKEN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17851582 ↗
• MalfunctionOct 2, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THE SUTURE IS EASILY BROKEN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17851580 ↗
• MalfunctionOct 2, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THE SUTURE IS EASILY BROKEN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17851579 ↗
• MalfunctionJul 7, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT THE SUTURES ARE NOT EXPIRED BUT STAFF IS SEEING "WEAR AND TEAR" WHEN THEY OPEN THE SUTURE PACKAGING. IT WAS UNKNOWN IF THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14952059 ↗

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.