NUROLON C584DRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10705031023987), received between Dec 8, 2017 and May 11, 2026 — classified as 1 injury, 31 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NEUROSURGERY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN NEUROSURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY DURING USE. IT APPEARED THAT THE NEEDLE WAS BROKEN AT THE SWAGE PART WHEN THE PRODUCT WAS CHECKED. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25135939 ↗
• MalfunctionMay 1, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT, THE NEEDLE TIP BROKE OFF DURING THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE AND THE NEEDLE TIP WAS RETRIEVED AND SAVED FOR ANALYSIS. THE DEVICE WAS RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058127 ↗
• MalfunctionNov 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED WHEN PASSING THE NEEDLE THROUGH, THE NEEDLE WAS BROKEN. THE BROKEN NEEDLE HAS BEEN COLLECTED. IT HAS RECEIVED A REQUEST TO INVESTIGATE THE REMAINING 9 PACKAGES. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23575543 ↗
• MalfunctionNov 14, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE AND NEEDLE WERE DETACHED. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556177 ↗
• MalfunctionNov 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CRANIOTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A CRANIOTOMY PROCEDURE, THAT THE NEEDLES ARE BREAKING AND POPPING OFF TOO EASILY, AND THE SUTURES ARE ALSO BREAKING WITH MINIMAL FORCE. NO PATIENT CONSEQUENCES HAVE BEEN REPORTED. THE DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23525968 ↗
• MalfunctionNov 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CRANIOTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A CRANIOTOMY PROCEDURE, THAT THE NEEDLES ARE BREAKING AND POPPING OFF TOO EASILY, AND THE SUTURES ARE ALSO BREAKING WITH MINIMAL FORCE. NO PATIENT CONSEQUENCES HAVE BEEN REPORTED. THE DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23525790 ↗
• MalfunctionOct 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP BY THE SURGEON THAT THE NEEDLE BROKE DURING PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23403152 ↗
• MalfunctionFeb 20, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE BROKE ON THE SUTURE, NEAR THE SWAGE SITE OF THE NEEDLE. BOTH PIECES WERE RETRIEVED WITH NO OTHER INTERVENTION. SURGICAL DELAY UNKNOWN. THERE WAS NO PATIENT CONSEQUENCES REPORTED. DEVICES ARE NOT RETURNING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21423490 ↗
• MalfunctionFeb 20, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE BROKE ON THE SUTURE, NEAR THE POINT OF THE NEEDLE. BOTH PIECES WERE RETRIEVED WITH NO OTHER INTERVENTION. SURGICAL DELAY UNKNOWN. THERE WAS NO PATIENT CONSEQUENCES REPORTED. DEVICES ARE NOT RETURNING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21423487 ↗
• MalfunctionJan 22, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CRANIOTOMY ON (B)(6)2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE ON THE SUTURE BROKE OFF ALMOST EXACTLY NEAR THE SWAGE SITE, ALTHOUGH THERE WAS STILL SOME REMNANT OF THE NEEDLE ATTACHED TO THE SUTURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21207728 ↗
• MalfunctionNov 21, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN NEUROSURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE WAS BROKEN AND SPLATTERED DURING SUTURING. IT WAS NOT A BIG PROBLEM BECAUSE IT WAS BLOWN OUT OF THE BODY. IT WAS A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20750597 ↗
• MalfunctionSep 23, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 30-JUL2024 AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, IT WAS A CONTROL RELEASE NEEDLE. THE NEEDLE WAS BROKEN EVEN THOUGH NO FORCE WAS EXERTED WHEN IT WAS USED. NO PIECE WAS LEFT INSIDE THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20280773 ↗
• MalfunctionJun 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE HAD BEEN DETACHED JUST BY SUTURING. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19560059 ↗
• MalfunctionApr 18, 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 WAS REPORTED THAT IT WAS FOUND THAT THERE HAD BEEN A FOREIGN SUBSTANCE LIKE A BLACK POWDER. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19133628 ↗
• MalfunctionApr 18, 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 WAS REPORTED THAT IT WAS FOUND THAT THERE HAD BEEN A FOREIGN SUBSTANCE LIKE A BLACK POWDER. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19133627 ↗
• MalfunctionApr 18, 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 WAS REPORTED THAT IT WAS FOUND THAT THERE HAD BEEN A FOREIGN SUBSTANCE LIKE A BLACK POWDER. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19133623 ↗
• MalfunctionMar 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18905304 ↗
• InjuryMar 13, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CRANIOTOMY ON (B)(6) 2024 AND SUTURE WAS USED. THE SURGEON REALIZED THAT THE NEEDLE TIP WAS BROKEN DURING DURAL SUTURE. THE SURGEON COULDN¿T FIND THE NEEDLE TIP SO THERE IS A POSSIBILITY THAT THE NEEDLE TIP WAS LEFT INSIDE THE BODY. ALSO STATED, WHEN COUNTING THE NEEDLES, THE SURGEON REALIZED THAT NEEDLE TIP WAS BROKEN. THE SURGERY WAS A NEUROSURGERY. THE PATIENT IS IN THE HOSPITAL. OTHER CONTRIBUTING FACTORS COULD BE THAT THERE WAS A POSSIBILITY THAT THE NEEDLE WAS BITTEN TOO MUCH BY THE NEEDLE HOLDER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18895749 ↗
• MalfunctionSep 19, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CRANIOTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE FIRST SUTURE POPPED OFF. THE SECOND ONE HAD THE NEEDLE POP OFF. THE THIRD ONE WORKED AND WAS ABLE TO COMPLETE CASE. NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17773962 ↗
• MalfunctionSep 19, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CRANIOTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE FIRST SUTURE POPPED OFF. THE SECOND ONE HAD THE NEEDLE POP OFF. THE THIRD ONE WORKED AND WAS ABLE TO COMPLETE CASE. NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17773894 ↗
• MalfunctionOct 11, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE TIP BROKE. THERE WAS NO EFFECT ON THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15580246 ↗
• MalfunctionAug 25, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THERE WERE SUPPOSED TO 8 CONTROL RELEASE NEEDLES IN THE PACKAGE, BUT THERE WAS A DIFFERENT NEEDLE AT THE VERY END. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15299135 ↗
• MalfunctionFeb 17, 2021Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11339806 ↗
• MalfunctionJan 4, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN NEUROSURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING USE, FOR DURA MATER LIFTING, THE NEEDLE WAS BROKEN AT THE TIP. THE LOT NUMBER IS UNKNOWN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11113668 ↗
• MalfunctionSep 18, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE AT THE TIP AS IT WAS HELD WHILE PULLING THE SUTURE. NO PIECES FELL INTO THE PATIENT. THE BROKEN NEEDLE PIECE WAS FOUND. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10554569 ↗

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-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.