ETHIBOND EXCEL X524HRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705031057470), received between May 11, 2021 and Jan 22, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED TO THE DISTRIBUTOR BY THE CUSTOMER THAT THE NEEDLES CAME OFF SUTURE EASILY DURING USE. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24144423 ↗
• MalfunctionJan 22, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED TO THE DISTRIBUTOR BY THE CUSTOMER THAT THE NEEDLES CAME OFF SUTURE EASILY DURING USE. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24144417 ↗
• MalfunctionDec 4, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SWAGE PART OF THE NEEDLE-SUTURE WAS BROKEN. THIS PRODUCT WAS USED ON THE RECTUS ABDOMINIS MUSCLE PART FOR UMBILICAL HERNIA, AND IT COULD BE POSSIBLE THAT WHEN APPLYING THIS PRODUCT TO THE TISSUE, THE NEEDLE-HOLDER SLIGHTLY CAUGHT THE SWAGE PART. THE DOCTOR RECOGNIZES THAT THE SWAGE PART IS EASY TO BREAK. THE SWAGE PART OF THE NEEDLE-SUTURE WAS BROKEN. THIS PRODUCT WAS USED ON THE RECTUS ABDOMINIS MUSCLE PART FOR UMBILICAL HERNIA, AND IT COULD BE POSSIBLE THAT WHEN APPLYING THIS PRODUCT TO THE TISSUE, THE NEEDLE HOLDER SLIGHTLY CAUGHT THE SWAGE PART. THE DOCTOR RECOGNIZES THAT THE SWAGE PART IS EASY TO BREAK. IT WAS NOT A CONTROL RELEASE NEEDLE. NO BROKEN PIECES FELL INTO THE SURGICAL FIELD. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715042 ↗
• MalfunctionNov 8, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC TOTAL HYSTERECTOMY+BILATERAL ADNEXECTOMY+ANTERIOR VAGINAL WALL SHORTENING SURGERY+VAGINAL STUMP SUSPENSION PROCEDURE ON (B)(6) 2024 AND A SUTURE DEVICE WAS USED. DOCTOR SUTURED THE TOP OF THE ANTERIOR VAGINAL WALL WITH SUTURE TO SHORTEN THE ANTERIOR WALL. THE REMAINING END WAS SUSPENDED ON THE SAME SIDE OF THE CIRCULAR LIGAMENT WITH SUTURE. DURING THE SUTURING PROCESS, THE SUTURES BROKE SEVERAL TIMES, MAKING IT DIFFICULT TO SUTURE SMOOTHLY. AFTER MULTIPLE REPLACEMENTS, THE SURGERY WAS COMPLETED, WHICH MAY LEAD TO A RISK OF INFECTION AND DELAY IN TREATMENT FOR THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641205 ↗
• MalfunctionNov 8, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC TOTAL HYSTERECTOMY+BILATERAL ADNEXECTOMY+ANTERIOR VAGINAL WALL SHORTENING SURGERY+VAGINAL STUMP SUSPENSION PROCEDURE ON (B)(6) 2024 AND A SUTURE DEVICE WAS USED. DOCTOR SUTURED THE TOP OF THE ANTERIOR VAGINAL WALL WITH SUTURE TO SHORTEN THE ANTERIOR WALL. THE REMAINING END WAS SUSPENDED ON THE SAME SIDE OF THE CIRCULAR LIGAMENT WITH SUTURE. DURING THE SUTURING PROCESS, THE SUTURES BROKE SEVERAL TIMES, MAKING IT DIFFICULT TO SUTURE SMOOTHLY. AFTER MULTIPLE REPLACEMENTS, THE SURGERY WAS COMPLETED, WHICH MAY LEAD TO A RISK OF INFECTION AND DELAY IN TREATMENT FOR THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641126 ↗
• MalfunctionMay 22, 2024Material Frayed; Material Integrity Problem; Material Frayed; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DEFECTIVE AND FRAYING. SEVERAL SUTURES OF THE SAME LOT WERE FOUND TO FRAY AND NOT TIE CAUSING, ADDED TIME TO THE HERNIA REPAIR CASE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19370758 ↗
• MalfunctionMay 22, 2024Material Frayed; Material Integrity Problem; Material Frayed; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DEFECTIVE AND FRAYING. SEVERAL SUTURES OF THE SAME LOT WERE FOUND TO FRAY AND NOT TIE CAUSING, ADDED TIME TO THE HERNIA REPAIR CASE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19370750 ↗
• MalfunctionMar 7, 2024Material Frayed; Product Quality Problem; Material Frayed; Product Quality Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS FRAYING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18859870 ↗
• MalfunctionFeb 28, 2024Material Frayed; Difficult to Open or Remove Packaging Material; Material Frayed; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS FRAYED AND WAS GETTING STUCK WHILE PERFORMING A ROBOTIC HERNIA REPAIR PROCEDURE WHICH RESULTED IN A TORN MUSCLE. THEY ENDED UP GETTING A DIFFERENT LOT NUMBER TO COMPLETE THE CASE WITHOUT PATIENT HARM. THERE WAS A DELAY DUE TO MUSCLE TEAR AND THE FACILITY DID FILE AN INCIDENT REPORT ABOUT THE ISSUE AS WELL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18797141 ↗
• MalfunctionOct 26, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC INCISIONAL HERNIA REPAIR PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. WHILE USING THE PRODUCT TO SUTURE THE HERNIA PORTAL, THE NEEDLE BROKE OFF AT THE SWAGE PART AND THE NEEDLE TIP WAS LOST. FLUOROSCOPY CONFIRMED THAT THE NEEDLE REMAINED WITHIN THE ABDOMINAL WALL AND WAS REMOVED. 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 18012806 ↗
• MalfunctionJul 13, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OVARIAN TORSION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE HEAD OF NURSES UPDATE THAT IN OVARIAN TORSION SURGERY THAT PREFORMED WEEK AGO IN THE SURGERY THE NEEDLE WAS BROKEN WHILE THE SURGEON TRY TO STRAIGHTEN THE NEEDLE. IN ORDER TO FINISH THE SURGERY, THEY OPEN NEW SUTURE. THE SURGERY END SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17319844 ↗
• MalfunctionApr 27, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INCISIONAL HERNIA SURGERY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. A NEEDLE WAS INSERTED TO SUTURE THE MUSCLE, BUT IT WAS VERY HARD, AND THE NEEDLE TIP WAS BROKEN. BECAUSE THE SITE WHERE THE NEEDLE TIP FELL COULD BE CONFIRMED WITH THE EYES, IT WAS IMMEDIATELY TAKEN OUT. CHANGED TO ANOTHER PRODUCT BECAUSE THE NEEDLE COULD NOT PASS THROUGH A RIGID MUSCLE AND COMPLETED SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14219747 ↗
• MalfunctionApr 27, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INCISIONAL HERNIA SURGERY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. A NEEDLE WAS INSERTED TO SUTURE THE MUSCLE, BUT IT WAS VERY HARD, AND THE NEEDLE TIP WAS BROKEN. BECAUSE THE SITE WHERE THE NEEDLE TIP FELL COULD BE CONFIRMED WITH THE EYES, IT WAS IMMEDIATELY TAKEN OUT. CHANGED TO ANOTHER PRODUCT BECAUSE THE NEEDLE COULD NOT PASS THROUGH A RIGID MUSCLE AND COMPLETED SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14219688 ↗
• MalfunctionMay 11, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEARTWARE LEFT VENTRICULAR ASSIST DEVICE INSERTION WITH INTRAOPERATIVE TEE PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN NEEDLE DRIVING THROUGH THE FASCIA, 4/5TH'S OF THE NEEDLE BROKE OFF PRESUMABLY IN THE SKIN. WE COULD NOT FIND THE MISSING PORTION OF THE NEEDLE AFTER EXTENSIVE SEARCH USING A STERILE MAGNET IN THE OR FIELD, AP AND LATERAL X-RAYS OF THE PATIENT AND MAGNET SEARCH OFF OF THE STERILE FIELD." DELAY OF SURGERY RELATED TO THE EXTENSIVE SEARCH FOR THE MISSING NEEDLE PORTION. IT IS UNKNOWN IF THERE WAS ANY PATIENT HARM, POTENTIALLY DEPENDING ON THE MISSING PORTION OF THE NEEDLE. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11810342 ↗

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.