ETHICON 744GRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031009684), received between Aug 21, 2019 and Jun 20, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. THE NEEDLE BROKE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298631 ↗
• MalfunctionJun 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING TWO DIFFERENT UNKNOWN SURGERIES, NEEDLES BREAKING. CASES WERE COMPLETED WITH A LIKE DEVICE. NO PATIENT HARM WAS REPORTED. DEVICE IS AVAILABLE FOR RETURN FOR ONE CASE, BUT NOT THE OTHER.. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293333 ↗
• MalfunctionJun 4, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING TWO DIFFERENT UNKNOWN SURGERIES, NEEDLES BREAKING. CASES WERE COMPLETED WITH A LIKE DEVICE. NO PATIENT HARM WAS REPORTED. DEVICE IS AVAILABLE FOR RETURN FOR ONE CASE, BUT NOT THE OTHER. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22142987 ↗
• MalfunctionJun 4, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING TWO DIFFERENT UNKNOWN SURGERIES, NEEDLES BREAKING. CASES WERE COMPLETED WITH A LIKE DEVICE. NO PATIENT HARM WAS REPORTED. DEVICE IS AVAILABLE FOR RETURN FOR ONE CASE, BUT NOT THE OTHER. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22142984 ↗
• MalfunctionSep 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY SALES REP THAT DURING AN UNKNOWN PROCEDURE; THE NEEDLE BROKE DURING USE AND MD WAS VERY UPSET. SURGICAL DELAY UNKNOWN. DEVICE AVAILABILITY UNKNOWN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20306488 ↗
• MalfunctionSep 16, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OTOLARYNGOLOGIC PROCEDURE ON 9/1/2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. A NEW SUTURE WAS USED TO COMPLETE THE CASE WITH NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15437075 ↗
• MalfunctionApr 1, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE TO REPAIR AN UNKNOWN STRUCTURE ON AN UNKNOWN DATE IN (B)(6) 2022 AND SUTURE WAS USED. DURING USE ON THE PATIENT, THE NEEDLE WAS DESCRIBED AS BREAKING INTO 2 PARTS. BOTH PARTS WERE RECOVERED FROM THE PATIENT WITH NO CONSEQUENCE TO THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13981307 ↗
• MalfunctionAug 21, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BREAST AUGMENTATION ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8914567 ↗
• MalfunctionAug 21, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BREAST AUGMENTATION ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8914566 ↗
• MalfunctionAug 21, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BREAST AUGMENTATION ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8914565 ↗
• MalfunctionAug 21, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BREAST AUGMENTATION ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8914563 ↗

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.