ETHILON 1663GRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10705031001725), received between Apr 9, 2018 and Sep 25, 2026 — classified as 7 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (17 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50892648 ↗
• InjurySep 25, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50892646 ↗
• InjurySep 25, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50892645 ↗
• InjurySep 25, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50892644 ↗
• InjurySep 25, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50892642 ↗
• InjurySep 25, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50892641 ↗
• MalfunctionDec 2, 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. DURING SURGERY, BEFORE OPENING THE PACKAGE, UPON VISUAL INSPECTION, THE RUST-LIKE FOREIGN MATTER WAS ATTACHED TO THE NEEDLE SWAGE PART. 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 23691886 ↗
• MalfunctionJun 30, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE. IT OCCURRED WITH 3 PACKS IN A ROW. 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 22358826 ↗
• MalfunctionJun 30, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE. IT OCCURRED WITH 3 PACKS IN A ROW. 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 22358815 ↗
• MalfunctionJun 30, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE. IT OCCURRED WITH 3 PACKS IN A ROW. 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 22358620 ↗
• MalfunctionJun 28, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. DURING THE MIDDLE OF THE THE CASE, THE SUTURES KEPT BREAKING. THEY WERE ABLE TO GET SUTURES FROM A DIFFERENT LOT TO COMPLETE THE CASE WITHOUT PATIENT HARM. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19637422 ↗
• MalfunctionJun 21, 2024Device 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 FOUND THAT THERE HAD BEEN A ONE FOREIGN MATTER IN THE STERILIZATION PACKAGE BY AN INSPECTION OF THE PLANT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19584969 ↗
• MalfunctionFeb 7, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING IN DOYLE SPLINTS TO THE SEPTUM, THE PROVIDER NOTED THAT THE SUTURE SUDDENLY SEEMED DULL AND THEN QUICKLY NOTED THAT THE TIP OF THE SUTURE NEEDLE HAD BROKEN OFF. NO UNUSUAL FORCE ON THE NEEDLE USED THAT COULD EXPLAIN THE BREAKING OF THE NEEDLE. THE END THAT HAD BROKEN OFF WAS FOUND IMMEDIATELY IN THE NEEDLE DRIVER TEETH AND WAS REMOVED FROM FIELD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18658917 ↗
• MalfunctionDec 27, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SHOULDER REPAIR PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE NEEDLES ARE POPPING OFF THE SUTURE, TWO OPEN BOXES WITH SAME ISSUE AND 1 UNOPENED BOX - ALL SAME LOT NUMBER. THE SURGERY WAS DELAYED 5-10 MINUTES. A DIFFERENT LOT WAS OPENED WHEN THIS EVENT OCCURRED, AND ALL WAS FINE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18403474 ↗
• MalfunctionDec 27, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SHOULDER REPAIR PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE NEEDLES ARE POPPING OFF THE SUTURE, TWO OPEN BOXES WITH SAME ISSUE AND 1 UNOPENED BOX - ALL SAME LOT NUMBER. THE SURGERY WAS DELAYED 5-10 MINUTES. A DIFFERENT LOT WAS OPENED WHEN THIS EVENT OCCURRED, AND ALL WAS FINE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18403473 ↗
• MalfunctionDec 27, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SHOULDER REPAIR PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE NEEDLES ARE POPPING OFF THE SUTURE, TWO OPEN BOXES WITH SAME ISSUE AND 1 UNOPENED BOX - ALL SAME LOT NUMBER. THE SURGERY WAS DELAYED 5-10 MINUTES. A DIFFERENT LOT WAS OPENED WHEN THIS EVENT OCCURRED, AND ALL WAS FINE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18402902 ↗
• MalfunctionApr 12, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE KEPT BREAKING ON SURGEON WHO SAID IT WAS FALLING APART. AS THEY WERE TYING THE SUTURE IT WAS BREAKING. THEY MENTIONED THAT THIS WAS HAPPENING SEVERAL TIMES OUT OF THIS BOX OF SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16727577 ↗
• MalfunctionApr 12, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE KEPT BREAKING ON SURGEON WHO SAID IT WAS FALLING APART. AS THEY WERE TYING THE SUTURE IT WAS BREAKING. THEY MENTIONED THAT THIS WAS HAPPENING SEVERAL TIMES OUT OF THIS BOX OF SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16727173 ↗
• MalfunctionApr 12, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE KEPT BREAKING ON SURGEON WHO SAID IT WAS FALLING APART. AS THEY WERE TYING THE SUTURE IT WAS BREAKING. THEY MENTIONED THAT THIS WAS HAPPENING SEVERAL TIMES OUT OF THIS BOX OF SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16727096 ↗
• MalfunctionApr 12, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE KEPT BREAKING ON SURGEON WHO SAID IT WAS FALLING APART. AS THEY WERE TYING THE SUTURE IT WAS BREAKING. THEY MENTIONED THAT THIS WAS HAPPENING SEVERAL TIMES OUT OF THIS BOX OF SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16727082 ↗
• MalfunctionApr 12, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE KEPT BREAKING ON SURGEON WHO SAID IT WAS FALLING APART. AS THEY WERE TYING THE SUTURE IT WAS BREAKING. THEY MENTIONED THAT THIS WAS HAPPENING SEVERAL TIMES OUT OF THIS BOX OF SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16726863 ↗
• MalfunctionApr 12, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE KEPT BREAKING ON SURGEON WHO SAID IT WAS FALLING APART. AS THEY WERE TYING THE SUTURE IT WAS BREAKING. THEY MENTIONED THAT THIS WAS HAPPENING SEVERAL TIMES OUT OF THIS BOX OF SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16726733 ↗
• InjuryJun 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTECTOMY PROCEDURE ON AN UNKNOWN DATE IN 2020 AND SUTURE WAS USED. IT WAS REPORTED BY A FRIEND THAT THE PATIENT EXPERIENCED A REACTION LIKELY DUE TO THE SUTURE. THE PATIENT HAS BEEN BACK TO THE HOSPITAL TWICE SINCE THE PROCEDURE TO HAVE THE WOUND CLEANED OUT AND RE-SUTURED DUE TO SEVERE INFECTION. THE PATIENT IS CURRENTLY STABLE AND SEEMS TO BE IMPROVING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Local Reaction; Pain; Unspecified Infection

  MAUDE report 12095538 ↗
• MalfunctionAug 27, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING EVALUATION, ANOTHER NEEDLE WAS OBSERVED BROKEN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10463350 ↗
• MalfunctionAug 25, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10448428 ↗

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.