ETHILON 7718GRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705031010529), received between Jul 7, 2020 and Feb 12, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (5 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.

• MalfunctionFeb 12, 2026Dull, Blunt; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE FAILED WHEN IT PENETRATED THE EYE. IT WAS DULL. AFTER COMPLETING THE FORM, WE REQUESTED THAT THE WAREHOUSE COLLECT THE "DEFECTIVE" PRODUCT AND EXCHANGE IT FOR OTHER UNITS. UPON RECEIVING THE "DEFECTIVE" SUTURES, IT WAS EVIDENT THAT THE PRODUCT WAS NOT OURS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24327498 ↗
• MalfunctionNov 18, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE FAILED WHEN IT PENETRATED THE EYE. IT WAS DULL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582401 ↗
• MalfunctionOct 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT PTERYGIUM EXCISION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. SUTURE FAILURE IS REPORTED: WHEN MANIPULATING THE SUTURE NEEDLE, IT IS CUT, PREVENTING THE SURGICAL POINT IN THE PTERYGIUM OF THE PATIENT'S LEFT EYE. AS A RESULT, IT WAS NECESSARY TO OPEN AN ADDITIONAL SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23210283 ↗
• MalfunctionJun 27, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS FOUND THAT THERE WAS A FOREIGN MATTER WHEN THE PACKAGE WAS OPENED AND USE WAS STOPPED. THIS EVENT WAS FOUND BEFORE USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22350312 ↗
• MalfunctionApr 2, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRABECULECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THERE WAS THREAD BREAKAGE. REPLACED WITH THE SAME THREAD, THE DOCTOR MANAGED TO FINISH WITH THE THIRD THREAD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751246 ↗
• MalfunctionApr 2, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRABECULECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THERE WAS THREAD BREAKAGE. REPLACED WITH THE SAME THREAD, THE DOCTOR MANAGED TO FINISH WITH THE THIRD THREAD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751245 ↗
• MalfunctionSep 3, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OPHTHALMOLOGY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN OPENED THE PACKAGE, IT WAS CONFIRMED THAT FOREIGN MATTER ADHERED TO THE TIP OF THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20127723 ↗
• MalfunctionAug 25, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, BREAKING WIRE OCCURRED WHEN MANIPULATED IN NEEDLE DOOR , FRAGILE WIRE TO USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17624022 ↗
• MalfunctionAug 8, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. THE SURGICAL SUTURE IS PRESENTING FRAGILITY IN ITS COMPOSITION. THE SUTURE EASILY RELEASES FROM THE TIP FOR MINIMAL HANDLING. TO EXCLUDE POSSIBILITY OF FRAGILITY BY HANDLING MATERIALS, MATERIAL CHANGES WERE PERFORMED, SUCH AS NEEDLE HOLDER, BUT THE SUTURE REMAINED CAUSING THE SAME PROBLEM, BREAKING IN THE SAME PLACE AT ALL TIMES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17484350 ↗
• MalfunctionMar 13, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT THE THREAD WAS THICKER AND NEEDLE THICKER. AN EXCHANGE WAS MADE FOR THE SAME PRODUCT WITH A DIFFERENT BATCH, IN ORDER TO FIND OUT IF IT WAS THE MATERIAL OR JUST THE DEFECTIVE BATCH.NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16535227 ↗
• MalfunctionMar 13, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT THE THREAD WAS THICKER AND NEEDLE THICKER. AN EXCHANGE WAS MADE FOR THE SAME PRODUCT WITH A DIFFERENT BATCH, IN ORDER TO FIND OUT IF IT WAS THE MATERIAL OR JUST THE DEFECTIVE BATCH. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16535226 ↗
• MalfunctionMar 13, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT THE THREAD WAS THICKER AND NEEDLE THICKER. AN EXCHANGE WAS MADE FOR THE SAME PRODUCT WITH A DIFFERENT BATCH, IN ORDER TO FIND OUT IF IT WAS THE MATERIAL OR JUST THE DEFECTIVE BATCH. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16535225 ↗
• MalfunctionMar 13, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT THE THREAD WAS THICKER AND NEEDLE THICKER. AN EXCHANGE WAS MADE FOR THE SAME PRODUCT WITH A DIFFERENT BATCH, IN ORDER TO FIND OUT IF IT WAS THE MATERIAL OR JUST THE DEFECTIVE BATCH.NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16535224 ↗
• MalfunctionMar 13, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT THE THREAD WAS THICKER AND NEEDLE THICKER. AN EXCHANGE WAS MADE FOR THE SAME PRODUCT WITH A DIFFERENT BATCH, IN ORDER TO FIND OUT IF IT WAS THE MATERIAL OR JUST THE DEFECTIVE BATCH. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16535223 ↗
• MalfunctionAug 21, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PHACOEMULSIFICATION PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10437603 ↗
• MalfunctionAug 21, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PHACOEMULSIFICATION PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10437596 ↗
• MalfunctionJul 7, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPHTHALMIC PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, A SUTURE DETACHED FROM THE NEEDLE EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. IT WAS FURTHER REPORTED THAT AN EXTRA SUTURE WAS FOUND IN THE PACKAGE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10238879 ↗

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.