ETHILON 1667ZHRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705031467101), received between Apr 1, 2025 and Aug 21, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (12 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.

• MalfunctionAug 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE THAT THE NEEDLE POPPED OFF THE SUTURE DURING CLOSURE. NO PATIENT HARM WAS REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860561 ↗
• MalfunctionAug 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE THAT THE NEEDLE POPPED OFF THE SUTURE DURING CLOSURE. NO PATIENT HARM WAS REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860427 ↗
• MalfunctionApr 1, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARPAL TUNNEL RELEASE PROCEDURE ON (B)(6) 2025, AND SUTURE WAS USED. DURING, HE USED A SUTURE FOR THE LIGAMENT, AND HE WAS USING SURGICAL LOUPES WHERE HE NOTICED THAT WITH EVERY PASS THROUGH THE TISSUE THE FILAMENT BEGAN TO UNRAVEL, AND SMALL FIBERS CAME OUT OF IT. THE SURGEON TRIED TO USE 12 DIFFERENT SUTURES FROM THE SAME PACKAGE, AND THEY ALL HAD THE SAME MALFUNCTION. THE OR NURSE THEN GAVE HIM THE SAME SUTURE FROM A DIFFERENT CODE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE SURGEON MENTIONED THAT IT CAUSED A MINOR DELAY, APPROXIMATELY 10 MINUTES, BUT NO HARM WAS CAUSED TO THE TISSUE AND THE SURGERY WAS SUCCESSFUL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21740304 ↗
• MalfunctionApr 1, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARPAL TUNNEL RELEASE PROCEDURE ON (B)(6) 2025, AND SUTURE WAS USED. DURING, HE USED A SUTURE FOR THE LIGAMENT, AND HE WAS USING SURGICAL LOUPES WHERE HE NOTICED THAT WITH EVERY PASS THROUGH THE TISSUE THE FILAMENT BEGAN TO UNRAVEL, AND SMALL FIBERS CAME OUT OF IT. THE SURGEON TRIED TO USE 12 DIFFERENT SUTURES FROM THE SAME PACKAGE, AND THEY ALL HAD THE SAME MALFUNCTION. THE OR NURSE THEN GAVE HIM THE SAME SUTURE FROM A DIFFERENT CODE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE SURGEON MENTIONED THAT IT CAUSED A MINOR DELAY, APPROXIMATELY 10 MINUTES, BUT NO HARM WAS CAUSED TO THE TISSUE AND THE SURGERY WAS SUCCESSFUL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21740278 ↗
• MalfunctionApr 1, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARPAL TUNNEL RELEASE PROCEDURE ON (B)(6) 2025, AND SUTURE WAS USED. DURING, HE USED A SUTURE FOR THE LIGAMENT, AND HE WAS USING SURGICAL LOUPES WHERE HE NOTICED THAT WITH EVERY PASS THROUGH THE TISSUE THE FILAMENT BEGAN TO UNRAVEL, AND SMALL FIBERS CAME OUT OF IT. THE SURGEON TRIED TO USE 12 DIFFERENT SUTURES FROM THE SAME PACKAGE, AND THEY ALL HAD THE SAME MALFUNCTION. THE OR NURSE THEN GAVE HIM THE SAME SUTURE FROM A DIFFERENT CODE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE SURGEON MENTIONED THAT IT CAUSED A MINOR DELAY, APPROXIMATELY 10 MINUTES, BUT NO HARM WAS CAUSED TO THE TISSUE AND THE SURGERY WAS SUCCESSFUL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21740076 ↗
• MalfunctionApr 1, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARPAL TUNNEL RELEASE PROCEDURE ON (B)(6) 2025, AND SUTURE WAS USED. DURING, HE USED A SUTURE FOR THE LIGAMENT, AND HE WAS USING SURGICAL LOUPES WHERE HE NOTICED THAT WITH EVERY PASS THROUGH THE TISSUE THE FILAMENT BEGAN TO UNRAVEL, AND SMALL FIBERS CAME OUT OF IT. THE SURGEON TRIED TO USE 12 DIFFERENT SUTURES FROM THE SAME PACKAGE, AND THEY ALL HAD THE SAME MALFUNCTION. THE OR NURSE THEN GAVE HIM THE SAME SUTURE FROM A DIFFERENT CODE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE SURGEON MENTIONED THAT IT CAUSED A MINOR DELAY, APPROXIMATELY 10 MINUTES, BUT NO HARM WAS CAUSED TO THE TISSUE AND THE SURGERY WAS SUCCESSFUL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21740072 ↗
• MalfunctionApr 1, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARPAL TUNNEL RELEASE PROCEDURE ON (B)(6) 2025, AND SUTURE WAS USED. DURING, HE USED A SUTURE FOR THE LIGAMENT, AND HE WAS USING SURGICAL LOUPES WHERE HE NOTICED THAT WITH EVERY PASS THROUGH THE TISSUE THE FILAMENT BEGAN TO UNRAVEL, AND SMALL FIBERS CAME OUT OF IT. THE SURGEON TRIED TO USE 12 DIFFERENT SUTURES FROM THE SAME PACKAGE, AND THEY ALL HAD THE SAME MALFUNCTION. THE OR NURSE THEN GAVE HIM THE SAME SUTURE FROM A DIFFERENT CODE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE SURGEON MENTIONED THAT IT CAUSED A MINOR DELAY, APPROXIMATELY 10 MINUTES, BUT NO HARM WAS CAUSED TO THE TISSUE AND THE SURGERY WAS SUCCESSFUL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21739995 ↗
• MalfunctionApr 1, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARPAL TUNNEL RELEASE PROCEDURE ON (B)(6) 2025, AND SUTURE WAS USED. DURING, HE USED A SUTURE FOR THE LIGAMENT, AND HE WAS USING SURGICAL LOUPES WHERE HE NOTICED THAT WITH EVERY PASS THROUGH THE TISSUE THE FILAMENT BEGAN TO UNRAVEL, AND SMALL FIBERS CAME OUT OF IT. THE SURGEON TRIED TO USE 12 DIFFERENT SUTURES FROM THE SAME PACKAGE, AND THEY ALL HAD THE SAME MALFUNCTION. THE OR NURSE THEN GAVE HIM THE SAME SUTURE FROM A DIFFERENT CODE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE SURGEON MENTIONED THAT IT CAUSED A MINOR DELAY, APPROXIMATELY 10 MINUTES, BUT NO HARM WAS CAUSED TO THE TISSUE AND THE SURGERY WAS SUCCESSFUL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21739974 ↗
• MalfunctionApr 1, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARPAL TUNNEL RELEASE PROCEDURE ON (B)(6) 2025, AND SUTURE WAS USED. DURING, HE USED A SUTURE FOR THE LIGAMENT, AND HE WAS USING SURGICAL LOUPES WHERE HE NOTICED THAT WITH EVERY PASS THROUGH THE TISSUE THE FILAMENT BEGAN TO UNRAVEL, AND SMALL FIBERS CAME OUT OF IT. THE SURGEON TRIED TO USE 12 DIFFERENT SUTURES FROM THE SAME PACKAGE, AND THEY ALL HAD THE SAME MALFUNCTION. THE OR NURSE THEN GAVE HIM THE SAME SUTURE FROM A DIFFERENT CODE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE SURGEON MENTIONED THAT IT CAUSED A MINOR DELAY, APPROXIMATELY 10 MINUTES, BUT NO HARM WAS CAUSED TO THE TISSUE AND THE SURGERY WAS SUCCESSFUL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21739935 ↗
• MalfunctionApr 1, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARPAL TUNNEL RELEASE PROCEDURE ON (B)(6) 2025, AND SUTURE WAS USED. DURING, HE USED A SUTURE FOR THE LIGAMENT, AND HE WAS USING SURGICAL LOUPES WHERE HE NOTICED THAT WITH EVERY PASS THROUGH THE TISSUE THE FILAMENT BEGAN TO UNRAVEL, AND SMALL FIBERS CAME OUT OF IT. THE SURGEON TRIED TO USE 12 DIFFERENT SUTURES FROM THE SAME PACKAGE, AND THEY ALL HAD THE SAME MALFUNCTION. THE OR NURSE THEN GAVE HIM THE SAME SUTURE FROM A DIFFERENT CODE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE SURGEON MENTIONED THAT IT CAUSED A MINOR DELAY, APPROXIMATELY 10 MINUTES, BUT NO HARM WAS CAUSED TO THE TISSUE AND THE SURGERY WAS SUCCESSFUL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21739919 ↗
• MalfunctionApr 1, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARPAL TUNNEL RELEASE PROCEDURE ON (B)(6) 2025, AND SUTURE WAS USED. DURING, HE USED A SUTURE FOR THE LIGAMENT, AND HE WAS USING SURGICAL LOUPES WHERE HE NOTICED THAT WITH EVERY PASS THROUGH THE TISSUE THE FILAMENT BEGAN TO UNRAVEL, AND SMALL FIBERS CAME OUT OF IT. THE SURGEON TRIED TO USE 12 DIFFERENT SUTURES FROM THE SAME PACKAGE, AND THEY ALL HAD THE SAME MALFUNCTION. THE OR NURSE THEN GAVE HIM THE SAME SUTURE FROM A DIFFERENT CODE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE SURGEON MENTIONED THAT IT CAUSED A MINOR DELAY, APPROXIMATELY 10 MINUTES, BUT NO HARM WAS CAUSED TO THE TISSUE AND THE SURGERY WAS SUCCESSFUL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21739871 ↗
• MalfunctionApr 1, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARPAL TUNNEL RELEASE PROCEDURE ON (B)(6) 2025, AND SUTURE WAS USED. DURING, HE USED A SUTURE FOR THE LIGAMENT, AND HE WAS USING SURGICAL LOUPES WHERE HE NOTICED THAT WITH EVERY PASS THROUGH THE TISSUE THE FILAMENT BEGAN TO UNRAVEL, AND SMALL FIBERS CAME OUT OF IT. THE SURGEON TRIED TO USE 12 DIFFERENT SUTURES FROM THE SAME PACKAGE, AND THEY ALL HAD THE SAME MALFUNCTION. THE OPERATING ROOM NURSE THEN GAVE HIM THE SAME SUTURE FROM A DIFFERENT CODE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE SURGEON MENTIONED THAT IT CAUSED A MINOR DELAY, APPROXIMATELY 10 MINUTES, BUT NO HARM WAS CAUSED TO THE TISSUE AND THE SURGERY WAS SUCCESSFUL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21739832 ↗
• MalfunctionApr 1, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARPAL TUNNEL RELEASE PROCEDURE ON (B)(6) 2025, AND SUTURE WAS USED. DURING, HE USED A SUTURE FOR THE LIGAMENT, AND HE WAS USING SURGICAL LOUPES WHERE HE NOTICED THAT WITH EVERY PASS THROUGH THE TISSUE THE FILAMENT BEGAN TO UNRAVEL, AND SMALL FIBERS CAME OUT OF IT. THE SURGEON TRIED TO USE 12 DIFFERENT SUTURES FROM THE SAME PACKAGE, AND THEY ALL HAD THE SAME MALFUNCTION. THE OR NURSE THEN GAVE HIM THE SAME SUTURE FROM A DIFFERENT CODE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE SURGEON MENTIONED THAT IT CAUSED A MINOR DELAY, APPROXIMATELY 10 MINUTES, BUT NO HARM WAS CAUSED TO THE TISSUE AND THE SURGERY WAS SUCCESSFUL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21739749 ↗
• MalfunctionApr 1, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARPAL TUNNEL RELEASE PROCEDURE ON (B)(6) 2025, AND SUTURE WAS USED. DURING, HE USED A SUTURE FOR THE LIGAMENT, AND HE WAS USING SURGICAL LOUPES WHERE HE NOTICED THAT WITH EVERY PASS THROUGH THE TISSUE THE FILAMENT BEGAN TO UNRAVEL, AND SMALL FIBERS CAME OUT OF IT. THE SURGEON TRIED TO USE 12 DIFFERENT SUTURES FROM THE SAME PACKAGE, AND THEY ALL HAD THE SAME MALFUNCTION. THE OR NURSE THEN GAVE HIM THE SAME SUTURE FROM A DIFFERENT CODE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE SURGEON MENTIONED THAT IT CAUSED A MINOR DELAY, APPROXIMATELY 10 MINUTES, BUT NO HARM WAS CAUSED TO THE TISSUE AND THE SURGERY WAS SUCCESSFUL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21739692 ↗

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.