ETHILON 661HRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705031007703), received between Aug 10, 2018 and Oct 15, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

7 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 20, 2024Open, Classified

   Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

   Z-1097-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TUBALPLASTY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE THREAD IS COMING LOOSE FROM THE NEEDLE. THE SUTURE HAS BEEN PLACED IN STORAGE. NO CONSEQUENCES AT THIS TIME. NEEDLE STICK INJURY. NEEDLE REMAINING IN WOUND. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23300676 ↗
• MalfunctionOct 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FISTULA PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT UNDERWENT ARTERIOVENOUS FISTULA SURGERY WITH RENAL DIALYSIS ON THE LEFT FOREARM. THE DOCTOR USED SUTURE TO SUTURE THE SKIN INCISION FOR THE PATIENT. AFTER UNSEALING THE SUTURE, IT WAS FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED, MAKING IT IMPOSSIBLE TO SUTURE. THE DOCTOR IMMEDIATELY OPENED A NEW SUTURE FOR SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23300388 ↗
• MalfunctionMar 11, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AND SUTURE WAS USED. THE THREAD WAS BREAKING AND THE NEEDLE WAS FALLING OFF THE THREAD. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874932 ↗
• MalfunctionMar 11, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE, AND SUTURE WAS USED. THE THREAD WAS BREAKING AND THE NEEDLE WAS FALLING OFF THE THREAD. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874741 ↗
• MalfunctionFeb 21, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, ON THREAD BROKE. THE CUSTOMER SAID THAT THEY USED THE SUTURES GENTLY, BUT THIS HAPPENED ANYWAY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18747355 ↗
• InjuryDec 9, 2021Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE TO REMOVE A FOREIGN BODY IN DIGIT IV ON (B)(6) 2021 AND SUTURE WAS USED. WHILE CLOSING THE WOUND THEY DISCOVERED THAT THERE WERE COMING OF SMALL PARTICLES FROM THE SUTURE AND THE SKIN WAS COLORED BLACK WERE THE SUTURE HAD PASSED THROUGH THE SKIN. TO MAKE SURE NOT TO LEAVE ANY PARTICLES LEFT IN THE SKIN THEY HAD TO REMOVE A BIT OF SKIN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Skin Discoloration

  MAUDE report 12967819 ↗
• MalfunctionOct 12, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FACIAL REPAIR AND CLOSURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE IN HALF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12617447 ↗
• MalfunctionOct 12, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FACIAL REPAIR AND CLOSURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE IN HALF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12617442 ↗
• MalfunctionJan 12, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PEDIATRIC PLASTIC SURGERY ON (B)(6) 2019 AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE LOSES THE NEEDLE EASILY. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9579369 ↗
• MalfunctionOct 2, 2019Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE PULLED-OFF OF THE SUTURE DURING TISSUE PASSAGE. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9146879 ↗
• MalfunctionAug 10, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DIEP FLAP PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. THE NEEDLE BROKE DURING USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7773506 ↗
• MalfunctionAug 10, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DIEP FLAP PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. THE NEEDLE BROKE DURING USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7773440 ↗

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-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.