ETHIBOND EXCEL PXX77NRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10705031462267), received between Jan 30, 2024 and Nov 4, 2025 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Material Separation” (24 reports).

8 other recalls cover devices cleared under the same FDA submission (K003070, 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP THAT THEY HAD ONE SUTURE ON THE PACK THAT WAS A WRONG NEEDLE IT WAS V5 NEEDLE INSTEAD THE V7 OTHER SUTURE WAS CORRECT. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT IS NOT FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23466899 ↗
• MalfunctionOct 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MITRAL VALVE REPAIR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A MITRAL VALVE REPAIR PROCEDURE THAT THE NEEDLE POPPED OFF THE SUTURE. THIS HAPPENED TWICE DURING THE PROCEDURE WITH TWO DIFFERENT SUTURE CODES. SUTURES WERE REPLACED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES. NO DEVICE RETURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20456548 ↗
• MalfunctionFeb 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VALVE REPAIR PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED FROM THE SURGEON AND STAFF BOUT MORE DEFECTIVE SUTURE. WHITE STRANDS SPECIFICALLY WHERE NEEDLES ARE POPPING OFF WITH MINIMAL TENSION DURING VALVE REPAIR THAT CAUSED A 20-MINUTE DELAY. INO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18668839 ↗
• MalfunctionFeb 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VALVE REPAIR PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED FROM THE SURGEON AND STAFF BOUT MORE DEFECTIVE SUTURE. WHITE STRANDS SPECIFICALLY WHERE NEEDLES ARE POPPING OFF WITH MINIMAL TENSION DURING VALVE REPAIR THAT CAUSED A 20-MINUTE DELAY. INO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18668838 ↗
• MalfunctionFeb 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VALVE REPAIR PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED FROM THE SURGEON AND STAFF BOUT MORE DEFECTIVE SUTURE. WHITE STRANDS SPECIFICALLY WHERE NEEDLES ARE POPPING OFF WITH MINIMAL TENSION DURING VALVE REPAIR THAT CAUSED A 20-MINUTE DELAY. INO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18668837 ↗
• MalfunctionFeb 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VALVE REPAIR PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED FROM THE SURGEON AND STAFF BOUT MORE DEFECTIVE SUTURE. WHITE STRANDS SPECIFICALLY WHERE NEEDLES ARE POPPING OFF WITH MINIMAL TENSION DURING VALVE REPAIR THAT CAUSED A 20-MINUTE DELAY. INO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18668834 ↗
• MalfunctionFeb 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VALVE REPAIR PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED FROM THE SURGEON AND STAFF BOUT MORE DEFECTIVE SUTURE. WHITE STRANDS SPECIFICALLY WHERE NEEDLES ARE POPPING OFF WITH MINIMAL TENSION DURING VALVE REPAIR THAT CAUSED A 20-MINUTE DELAY. INO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18668831 ↗
• MalfunctionFeb 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VALVE REPAIR PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED FROM THE SURGEON AND STAFF BOUT MORE DEFECTIVE SUTURE. WHITE STRANDS SPECIFICALLY WHERE NEEDLES ARE POPPING OFF WITH MINIMAL TENSION DURING VALVE REPAIR THAT CAUSED A 20-MINUTE DELAY. INO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18668829 ↗
• MalfunctionFeb 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VALVE REPAIR PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED FROM THE SURGEON AND STAFF BOUT MORE DEFECTIVE SUTURE. WHITE STRANDS SPECIFICALLY WHERE NEEDLES ARE POPPING OFF WITH MINIMAL TENSION DURING VALVE REPAIR THAT CAUSED A 20-MINUTE DELAY. INO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18668826 ↗
• MalfunctionFeb 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VALVE REPAIR PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED FROM THE SURGEON AND STAFF BOUT MORE DEFECTIVE SUTURE. WHITE STRANDS SPECIFICALLY WHERE NEEDLES ARE POPPING OFF WITH MINIMAL TENSION DURING VALVE REPAIR THAT CAUSED A 20-MINUTE DELAY. INO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18668822 ↗
• MalfunctionFeb 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VALVE REPAIR PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED FROM THE SURGEON AND STAFF BOUT MORE DEFECTIVE SUTURE. WHITE STRANDS SPECIFICALLY WHERE NEEDLES ARE POPPING OFF WITH MINIMAL TENSION DURING VALVE REPAIR THAT CAUSED A 20-MINUTE DELAY. INO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18668815 ↗
• MalfunctionFeb 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VALVE REPAIR PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED FROM THE SURGEON AND STAFF BOUT MORE DEFECTIVE SUTURE. WHITE STRANDS SPECIFICALLY WHERE NEEDLES ARE POPPING OFF WITH MINIMAL TENSION DURING VALVE REPAIR THAT CAUSED A 20-MINUTE DELAY. INO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18668814 ↗
• MalfunctionFeb 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED FROM THE SURGEON AND STAFF WITH ADDITIONAL ISSUES WITH THE WHITE STRANDS OF ETHIBOND POPPING OFF PREMATURELY WITH MINIMAL TENSION ON ANOTHER PROCEDURE. MULTIPLE STRANDS FROM MULTIPLE BOXES WITH SAME LOT NUMBER ARE AFFECTED. THEY STARTED USING ANOTHER LOT NUMBER WITH NO PROBLEMS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18667220 ↗
• MalfunctionFeb 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED FROM THE SURGEON AND STAFF WITH ADDITIONAL ISSUES WITH THE WHITE STRANDS OF ETHIBOND POPPING OFF PREMATURELY WITH MINIMAL TENSION ON ANOTHER PROCEDURE. MULTIPLE STRANDS FROM MULTIPLE BOXES WITH SAME LOT NUMBER ARE AFFECTED. THEY STARTED USING ANOTHER LOT NUMBER WITH NO PROBLEMS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18667219 ↗
• MalfunctionFeb 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED FROM THE SURGEON AND STAFF WITH ADDITIONAL ISSUES WITH THE WHITE STRANDS OF ETHIBOND POPPING OFF PREMATURELY WITH MINIMAL TENSION ON ANOTHER PROCEDURE. MULTIPLE STRANDS FROM MULTIPLE BOXES WITH SAME LOT NUMBER ARE AFFECTED. THEY STARTED USING ANOTHER LOT NUMBER WITH NO PROBLEMS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18667218 ↗
• MalfunctionFeb 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED FROM THE SURGEON AND STAFF WITH ADDITIONAL ISSUES WITH THE WHITE STRANDS OF ETHIBOND POPPING OFF PREMATURELY WITH MINIMAL TENSION ON ANOTHER PROCEDURE. MULTIPLE STRANDS FROM MULTIPLE BOXES WITH SAME LOT NUMBER ARE AFFECTED. THEY STARTED USING ANOTHER LOT NUMBER WITH NO PROBLEMS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18667215 ↗
• MalfunctionFeb 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED FROM THE SURGEON AND STAFF WITH ADDITIONAL ISSUES WITH THE WHITE STRANDS OF ETHIBOND POPPING OFF PREMATURELY WITH MINIMAL TENSION ON ANOTHER PROCEDURE. MULTIPLE STRANDS FROM MULTIPLE BOXES WITH SAME LOT NUMBER ARE AFFECTED. THEY STARTED USING ANOTHER LOT NUMBER WITH NO PROBLEMS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18667214 ↗
• MalfunctionFeb 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED FROM THE SURGEON AND STAFF WITH ADDITIONAL ISSUES WITH THE WHITE STRANDS OF ETHIBOND POPPING OFF PREMATURELY WITH MINIMAL TENSION ON ANOTHER PROCEDURE. MULTIPLE STRANDS FROM MULTIPLE BOXES WITH SAME LOT NUMBER ARE AFFECTED. THEY STARTED USING ANOTHER LOT NUMBER WITH NO PROBLEMS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18667213 ↗
• MalfunctionJan 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF EASILY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606031 ↗
• MalfunctionJan 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF EASILY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606029 ↗
• MalfunctionJan 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF EASILY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606024 ↗
• MalfunctionJan 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF EASILY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606020 ↗
• MalfunctionJan 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF EASILY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606017 ↗
• MalfunctionJan 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF EASILY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606015 ↗
• MalfunctionJan 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF EASILY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606013 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K003070, 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.