ETHICON M654GRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705031000063), received between Jun 19, 2018 and Mar 30, 2026 — classified as 4 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (13 reports).

8 other recalls cover devices cleared under the same FDA submission (K170767, 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN CARDIOVASCULAR PROCEDURE PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE 2 SUTURES WERE USED ON A PATIENT WHERE THEY BROKE WHILE BEING USED. THE REP CURRENTLY HAVE THE DEFECTIVE PRODUCT THAT WAS USED. THE VASCULAR TEAM MAINLY USES THOSE SUTURES DURING STERNAL CASES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WERE NO SIGNIFICANT DELAYS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24728018 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN CARDIOVASCULAR PROCEDURE PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE 2 SUTURES WERE USED ON A PATIENT WHERE THEY BROKE WHILE BEING USED. THE REP CURRENTLY HAVE THE DEFECTIVE PRODUCT THAT WAS USED. THE VASCULAR TEAM MAINLY USES THOSE SUTURES DURING STERNAL CASES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WERE NO SIGNIFICANT DELAYS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727366 ↗
• MalfunctionOct 30, 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 STAINLESS STEEL STERNAL WIRE BROKE IN THE MIDDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424502 ↗
• MalfunctionJul 16, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A STERNOTOMY CLOSURE ON (B)(6)2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE MULTIPLE TIMES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. DEVICE WAS DISPOSED OF. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22518803 ↗
• MalfunctionJul 16, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A STERNOTOMY CLOSURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE MULTIPLE TIMES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. DEVICE WAS DISPOSED OF. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22518802 ↗
• MalfunctionNov 29, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON 01/11/2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE STEEL WIRE BROKE DURING PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18227014 ↗
• MalfunctionNov 29, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE STEEL WIRE BROKE DURING PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18227010 ↗
• MalfunctionNov 29, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON 01/11/2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE STEEL WIRE BROKE DURING PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18227007 ↗
• MalfunctionApr 19, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE OF STEEL WIRE DISLODGED FROM THE WIRE WHILE THE SURGEON WAS ABOUT TO USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11685448 ↗
• InjuryDec 16, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE IN 2019 AND STERNAL WIRE WAS USED. ON AN UNKNOWN DATE, POST PROCEDURE, THE SUTURE BROKE. THE PATIENT WILL BE RETURNING TO THE OPERATING ROOM ON (B)(6) 2019. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Wound Dehiscence

  MAUDE report 9473132 ↗
• InjuryJul 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A STERNUM CLOSURE ON AN UNKNOWN DATE AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT RETURNED AN UNKNOWN NUMBER OF DAYS LATER, WITH A SUPERFICIAL INFECTION. THE DOCTOR REOPERATED ON THE PATIENT, REOPENED THE INCISION, WASHED OUT THE WOUND, NOTICED THE STEEL WIRE SUTURE WAS LOOSE AND TIGHTENED THE LOOSE SUTURE. THE PATIENT WAS DISCHARGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 8791277 ↗
• InjuryJul 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A STERNUM CLOSURE ON AN UNKNOWN DATE AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT RETURNED AN UNKNOWN NUMBER OF DAYS LATER, WITH A SUPERFICIAL INFECTION. THE DOCTOR REOPERATED ON THE PATIENT, REOPENED THE INCISION, WASHED OUT THE WOUND, NOTICED THE STEEL WIRE SUTURE WAS LOOSE AND TIGHTENED THE LOOSE SUTURE. THE PATIENT WAS DISCHARGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 8790189 ↗
• MalfunctionMar 4, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN MYOCARDIAL REVASCULARIZATION PROCEDURE ON (B)(6) 2019 AND A STAINLESS STEEL SUTURE WAS USED. DURING SURGERY, THE NEEDLE BROKE IN HALF WHILE UNDERGOING THE FIRST STITCH ON THE BONE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8386946 ↗
• MalfunctionSep 12, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE DOWN TO 2 PIECES AND THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7868408 ↗
• MalfunctionJul 25, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT VALVE PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED TO CLOSE THE STERNUM. THE TIP OF THE NEEDLE BROKE AND REMAINS INSIDE THE PATENT¿S STERNUM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7719570 ↗
• InjuryJun 21, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A QUADRUPLE HEART BYPASS PROCEDURE IN (B)(6) 2017 AND SUTURE WAS USED ON THE INCISION. AFTER THE PROCEDURE, THE PATIENT STARTED EXPERIENCING PAIN, RADIATING ACROSS THE CHEST AND ARMS. THE PATIENT RETURNED TO THE DOCTOR AND WAS PRESCRIBED PAIN MEDICATION. THE PATIENT IS STILL EXPERIENCING PAIN. THE PATIENT IS CURRENTLY SEEING A SPECIALIST FOR A POSSIBLE ALLERGY TO THE ALLOYS IN THE SUTURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Chest Pain

  MAUDE report 7627516 ↗
• MalfunctionJun 19, 2018Break; Break

  IT AS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE DOWN TO 2 PIECES AND THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7615464 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170767, 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.