ETHICON M651GRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031045446), received between Aug 9, 2022 and Feb 25, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2026Material Separation

  THE NEEDLE WAS BREAKING OFF THE STERNAL WIRE. ERROR OCCURRED BUT DID NOT REACH THE INDIVIDUAL. NO INJURY WAS REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24441842 ↗
• MalfunctionNov 20, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A CARDIAC PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE NEEDLE WAS POPPING OF THE SUTURE WHEN IT SHOULDN'T BE. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18170316 ↗
• MalfunctionNov 20, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A CARDIAC PROCEDURE ON 26-OCT.2023 AND SUTURE WAS USED. THE NEEDLE WAS POPPING OF THE SUTURE WHEN IT SHOULDN'T BE. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18170244 ↗
• MalfunctionAug 9, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2022 AND THE SUTURE WAS USED. DURING SURGERY, THE NEEDLE AND WIRE ARE CONTINUOUSLY BROKEN WHEN SUTURING IN STERNUM CLOSURE. THE OPERATOR TRIED TO MAINTAIN PROPER TENSION FOR NEEDLE PENETRATION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15195872 ↗
• MalfunctionAug 9, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2022 AND THE SUTURE WAS USED. DURING SURGERY, THE NEEDLE AND WIRE ARE CONTINUOUSLY BROKEN WHEN SUTURING IN STERNUM CLOSURE. THE OPERATOR TRIED TO MAINTAIN PROPER TENSION FOR NEEDLE PENETRATION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15195871 ↗
• MalfunctionAug 9, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE AND WIRE WERE CONTINUOUSLY BREAKING WHILE SUTURING IN STERNUM CLOSURE. THE OPERATOR TRIED TO MAINTAIN PROPER TENSION FOR NEEDLE PENETRATION. THE PRODUCT ISSUE OCCURRED IN SAME LOT NUMBER AND DEFECTIVE STRANDS WERE ALREADY DISCARDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15190766 ↗
• MalfunctionAug 9, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE AND WIRE WERE CONTINUOUSLY BREAKING WHILE SUTURING IN STERNUM CLOSURE. THE OPERATOR TRIED TO MAINTAIN PROPER TENSION FOR NEEDLE PENETRATION. THE PRODUCT ISSUE OCCURRED IN SAME LOT NUMBER AND DEFECTIVE STRANDS WERE ALREADY DISCARDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15190706 ↗

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-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.