ETHICON M653GRecalls & reported problems
Ethicon, LLC · Monofilament 316L Stainless Steel, Nonabsorbable Surgical Suture · Class 2 · Implant
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10705031045477), received between Nov 29, 2018 and Apr 29, 2026 — classified as 8 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Break” (17 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.
Reports received per month
Most reported problems
Device problems
- Break17
- Defective Component2
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Not Applicable5
- No Consequences Or Impact To Patient4
- Insufficient Information3
- Wound Dehiscence3
- Foreign Body In Patient2
- Granuloma2
- Blood Loss1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A STERNOTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE NEEDLE TIP BROKE OFF AFTER USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25035395 ↗MalfunctionMar 19, 2026Insufficient Device Problem Information
THE DEVICE WAS RECEIVED WITH NO COMPLAINT INFORMATION. ATTEMPTS WERE MADE TO RECONCILE THE DEVICE WITH NO SUCCESS RESULTING IN THE CREATION OF A NEW COMPLAINT. AWB (B)(4) RECEIVED 10/27/2025. BOX MARKED AS (B)(4) ON AWB (B)(4); RECD M653; LOT# UNKNOWN; ECM HAS M654G; LOT# UNKNOWN FROM COUNTRY SINGAPORE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24642948 ↗InjuryNov 7, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG ON (B)(6)2024 AND SUTURE WAS USED. ON (B)(6)2024, THE SURGEON CHECKED PATIENT STABILITY THROUGH X-RAY AND FOUND STERNUM WIRE BROKEN AT 3 PARTS. STERNUM WIRE WAS STITCHED USING FIGURE OF 8 TECHNIQUE, A TECHNIQUE SURGEON HAD USED FOR MORE THAN 20 YEARS. PATIENT WAS THEN REWIRED ON (B)(6)2024 USING SIMILAR METHOD AND NEW STEEL WIRE FROM NEW BOX. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20626862 ↗InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SIT WAS REPORTED THAT A PATIENT UNDERWENT A REOPERATION BECAUSE THE STEEL WIRE BROKE AFTER CABG. THE REOPERATION TOOK PLACE ON (B)(6) 2024. POST SECOND IMPLANT, PATIENT DEVELOPED WOUND BREAKDOWN DUE TO OSTEOPOROSIS AND BONE CUT THROUGH. THE WIRE WAS ALL STILL INTACT. PATIENT IS NOW IN CARE OF NATIONAL HEART CENTRE FOR PECTORALIS FLAP UNDER PLASTIC SURGEON. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Impaired Healing; Osteopenia/ Osteoporosis
MAUDE report 20626389 ↗InjuryOct 9, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. POST-OP, THE SUTURE WIRE BOKE, ACCORDING TO THE X-RAY IMAGES. THE PATIENT HAD TO RETURN TO THE OPERATING ROOM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20406233 ↗MalfunctionJan 29, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIAC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD WAS USED TO CLOSE THE STERNUM OF PATIENTS IN CARDIAC SURGERY, THE NEEDLE IS BREAKING IN HALF DURING USE. WHICH MAY FALL INTO THE PATIENT'S CAVITY AND REQUIRE MORE WIRES TO BE OPENED THAN NORMAL. AN OCCURRENCE WITH A REFERRED BATCH WAS OBSERVED, BUT THE MEDICAL TEAM REPORTED THAT OTHER EPISODES OCCURRED, BUT THEY DID NOT CHECK THE BATCHES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18597035 ↗MalfunctionNov 18, 2022Defective Component; Defective Component
IT WAS REPORTED THAT A PATIENT UNDERWENT A STERNOTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IN A TRAUMA SURGERY OPENS ACIFLEX CALIBER 5 AND IT IS OBSERVED THAT THE DIAMETER WAS SMALLER THAN THE SIZE THAT IS REAL. VERY THIN SUTURE GAUGE WAS OBSERVED. ANOTHER SUTURE IS OPENED AND THE SAME IS OBSERVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15822521 ↗MalfunctionNov 17, 2022Defective Component; Defective Component
IT WAS REPORTED THAT A PATIENT UNDERWENT A STERNOTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IN A TRAUMA SURGERY OPENS ACIFLEX CALIBER 5 AND IT IS OBSERVED THAT THE DIAMETER WAS SMALLER THAN THE SIZE THAT IS REAL. VERY THIN SUTURE GAUGE WAS OBSERVED. ANOTHER SUTURE IS OPENED AND THE SAME IS OBSERVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15818447 ↗MalfunctionMar 8, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE STERNAL WIRE BROKE DURING STITCHING CONSECUTIVELY FOR 3 CASES WHEN USED BY 2 DIFFERENT SURGEONS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13691490 ↗MalfunctionMar 8, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT ON (B)(6) 2022 AND SUTURE WAS USED. STERNAL WIRE BROKE DURING STITCHING CONSECUTIVELY FOR 3 CASES WHEN USED BY 2 DIFFERENT SURGEONS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13691455 ↗MalfunctionMar 8, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, STERNAL WIRE BROKE DURING STITCHING CONSECUTIVELY FOR 3 CASES WHEN USED BY 2 DIFFERENT SURGEONS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13691375 ↗MalfunctionOct 5, 2021Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A PARTIAL STERNOTOMY PROCEDURE ON (B)(6) 2021 AND THE SUTURE WAS USED. DURING THE PROCEDURE, WHEN SURGEON WAS PASSING THE NEEDLE THROUGH THE STERNUM, THE TIP OF THE NEEDLE BROKE OFF IN THE STERNUM ROUGHLY MIDWAY ON THE CURVED NEEDLE, HALF THE NEEDLE WAS LOST IN THE PATIENT. WHILE COMPLETING CLOSING, A SMALL TIP OF THE NEEDLE WAS MISSING, AND TIP COULD NOT BE REMOVED AND LEFT IT IN THE PATIENT. THERE IS NOT KNOWN HOW MANY PASSES, VARIES WHERE SURGEON PUT THE NEEDLE DRIVER. THE PATIENT WAS NOTIFIED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Foreign Body In Patient
MAUDE report 12578753 ↗MalfunctionApr 1, 2020Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A POST-OPERATIONAL STERNAL WOUND CLOSURE PROCEDURE AFTER AORTIC VALVE REPLACEMENT ON (B)(6) 2020 AND THE SUTURE WAS USED FOR CLOSING STERNAL POINTS. DURING THE PROCEDURE, THE TIP OF NEEDLE BROKE. THE CAVITY WAS SEARCHED FOR THE TIP AND IT WAS NOT FOUND. X-RAY WAS PERFORMED AND THERE WAS NO EVIDENCE OF NEEDLE TIP INSIDE OF THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9914500 ↗MalfunctionApr 1, 2020Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A POST-OPERATIONAL STERNAL WOUND CLOSURE PROCEDURE AFTER AORTIC VALVE REPLACEMENT ON (B)(6) 2020 AND THE SUTURE WAS USED FOR CLOSING STERNAL POINTS. IT WAS REPORTED THAT THE TIP OF NEEDLE BROKE. THE CAVITY WAS SEARCHED FOR THE TIP AND IT WAS NOT FOUND. X-RAY WAS PERFORMED AND THERE WAS NO EVIDENCE OF NEEDLE TIP INSIDE OF THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9914499 ↗MalfunctionOct 16, 2019Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE IS DISASSEMBLED WHEN USED. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9199176 ↗InjurySep 25, 2019Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT STERNAL SUTURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE POST-OPERATIVELY. THE PATIENT UNDERWENT REMOVAL OF SUTURE AND REVISION SURGERY ON (B)(6) 2019. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Not Applicable; Respiratory Failure; Wound Dehiscence
MAUDE report 9117818 ↗InjurySep 25, 2019Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT STERNAL SUTURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE POST-OPERATIVELY. THE PATIENT UNDERWENT REMOVAL OF SUTURE AND REVISION SURGERY ON (B)(6) 2019. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blood Loss; Not Applicable; Wound Dehiscence
MAUDE report 9117757 ↗InjurySep 25, 2019Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT STERNAL SUTURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE POST-OPERATIVELY. THE PATIENT UNDERWENT REMOVAL OF SUTURE AND REVISION SURGERY ON (B)(6) 2019. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Granuloma; Not Applicable; Pneumonia; Wound Dehiscence
MAUDE report 9117666 ↗InjurySep 25, 2019Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT STERNAL SUTURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE POST-OPERATIVELY. THE PATIENT UNDERWENT REMOVAL OF SUTURE AND REVISION SURGERY FOR SURGICAL WOUND RESUTURE ON (B)(6) 2019. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Fever; No Code Available; Not Applicable; Pain
MAUDE report 9115746 ↗InjurySep 25, 2019Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT STERNAL SUTURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE POST-OPERATIVELY. THE PATIENT UNDERWENT REMOVAL OF SUTURE AND REVISION SURGERY ON (B)(6) 2019. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Granuloma; Not Applicable; Unspecified Infection
MAUDE report 9115713 ↗MalfunctionDec 17, 2018Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG ON (B)(6) 2018 AND SUTURE WAS USED FOR STERNUM CLOSURE. DURING THE PROCEDURE, THE SUTURE SNAPPED AFTER THE FIRST BITE. THE SURGEON OPENED A NEW PACKAGE TO CLOSE THE STERNUM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8170268 ↗MalfunctionNov 29, 2018Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT PROCEDURE ON (B)(6) 2018, AND SUTURE WAS USED. DURING CLOSURE OF THE PATIENT¿S CHEST THE NEEDLE BROKE OFF IN THE PATIENT¿S STERNUM. ATTEMPTS TO RETRIEVE THE FRAGMENT WERE UNSUCCESSFUL. NO PATIENT CONSEQUENCE WAS REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 8116199 ↗
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, ClassifiedETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
- Z-1097-2025 · Dec 20, 2024 · Open, ClassifiedPERMA-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, ClassifiedPERMA-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 · TerminatedETHIBOND 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 · TerminatedETHIBOND 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 · TerminatedPERMA-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 · TerminatedEthicon 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 · TerminatedEthicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.
Other SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE devices
- ETHICON M660GEthicon, LLC · SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE102 reports
- ETHICON M650GEthicon, LLC · SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE68 reports
- ETHIBOND EXCEL X425HEthicon, LLC · SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE1 recall12 reports
- Steel 88862224-49Covidien LP · SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE1 recall3 reports
- ETHICON M655GEthicon, LLC · SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE46 reports
- ETHIBOND EXCEL MB66GEthicon, LLC · SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE42 reports
- Steel 88862424-89Covidien LP · SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE39 reports
- ETHICON M649GEthicon, LLC · SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE36 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.