NUROLONRecalls & reported problems across all models

We found 5 models of NUROLON by Ethicon, LLC in the FDA's device registry (GUDID). Together they are named in 40 adverse event reports in the FDA's MAUDE database, received between Dec 8, 2017 and May 11, 2026 — classified as 1 injury, 39 malfunctions.

The most frequently reported specific device problem is “Break” (27 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported NUROLON problems

NUROLON models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• NUROLON C584D

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
  32 reports
• NUROLON C554D

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
  3 reports
• NUROLON C553D

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
  2 reports
• NUROLON N104T

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
  2 reports
• NUROLON C503D

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
  1 report

Recent NUROLON adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionOct 9, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TUMOR RESECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN AWAKE TUMOR RESECTION FOR BRAIN TUMOR, THE PRODUCT INVOLVED WAS USED TO CLOSE THE CRANIAL DURA MATER. THE NEEDLE TIP WAS BROKEN WHEN PASSING THE NEEDLE THROUGH, SO A NEW PRODUCT OF THE SAME TYPE WAS USED, AND THE CLOSURE WAS SUCCESSFUL. DUE TO CONCERNS THAT THE NEEDLE TIP MAY HAVE REMAINED INSIDE THE BODY, A CT SCAN WAS PERFORMED AFTER THE SURGERY, BUT IT WAS DETERMINED THAT THERE WAS NO REMAINING INSIDE THE BODY. AS TWO CONSECUTIVE PACKAGES OF NEEDLE BREAKAGES OCCURRED, THE PRODUCTS FROM THE SAME LOT HAVE BEEN ISOLATED NOT TO BE USED. 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. THE LOCATION WHERE THE NEEDLE FRAGMENT FELL IS UNKNOWN. IT WAS DETERMINED THAT THERE WAS NO REMAINING, SO ADDITIONAL TREATMENT WAS NOT REQUIRED. THE NEEDLE FRAGMENT (THE TIP) HAVE NOT BEEN RETRIEVED. NO ADVERSE PATIEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23260258 ↗
• MalfunctionOct 9, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TUMOR RESECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN AWAKE TUMOR RESECTION FOR BRAIN TUMOR, THE PRODUCT INVOLVED WAS USED TO CLOSE THE CRANIAL DURA MATER. THE NEEDLE TIP WAS BROKEN WHEN PASSING THE NEEDLE THROUGH, SO A NEW PRODUCT OF THE SAME TYPE WAS USED, AND THE CLOSURE WAS SUCCESSFUL. DUE TO CONCERNS THAT THE NEEDLE TIP MAY HAVE REMAINED INSIDE THE BODY, A CT SCAN WAS PERFORMED AFTER THE SURGERY, BUT IT WAS DETERMINED THAT THERE WAS NO REMAINING INSIDE THE BODY. AS TWO CONSECUTIVE PACKAGES OF NEEDLE BREAKAGES OCCURRED, THE PRODUCTS FROM THE SAME LOT HAVE BEEN ISOLATED NOT TO BE USED. 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. THE LOCATION WHERE THE NEEDLE FRAGMENT FELL IS UNKNOWN. IT WAS DETERMINED THAT THERE WAS NO REMAINING, SO ADDITIONAL TREATMENT WAS NOT REQUIRED. THE NEEDLE FRAGMENT (THE TIP) HAVE NOT BEEN RETRIEVED. NO ADVERSE PATIEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23260255 ↗
• 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 27, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT VENTRICULO PERITONEAL SHUNT ON (B)(6) 2024 AND A SUTURE WAS USED. DURING THE INTERRUPTING SUTURE FOR CLOSING HEAD, THE SUTURE WAS USED FOR SUTURING THE GALEA, BUT THE NEEDLE WAS TOO LARGE TO FIT IN THE FINAL STITCH, SO ANOTHER SUTURE WAS USED. WHEN THE NEEDLE-SUTURE WAS APPLIED TO THE GALEA WHICH IS IN FRONT OF THE SURGEON AND THE OPPOSITE SIDE WAS SUTURED, THE SWAGE PART WAS GRASPED WITH A NEEDLE HOLDER AND THE NEEDLE WAS DEEPLY APPLIED TO THE GALEA AND IT WAS RELEASED, THE SWAGE PART WAS BROKEN AND FROM THE NEEDLE TIP TO THE BODY PART WAS TEMPORARILY BURIED IN THE TISSUE OF THE HEAD SKIN AND LOST SIGHT OF IT. THE SIDE OF THE SUTURE WAS REMOVED, BUT THE NEEDLE BODY COULD NOT BE FOUND WHERE IT HAD GONE, AND IT WAS SEARCHED FOR AND FOUND BY CT, SO IT REMOVED ALL OF THEM FROM THE PATIENT WITHOUT ADDITIONAL INCISION AS IT WAS. SINCE NO MISSING NEEDLE WAS FOUND, THE WOUND WAS CLOSED. THERE WAS NOTHING UNUSUAL AFTER THAT, AND THE BROKEN NEEDLE WAS REMOVED DURING THE SURGERY, SO THERE IS NO ADDITIONAL POSTOPERATIVE PROCEDURE OR RE-OPERATION. THE NURSE SAID THAT THE BROKEN NEEDLE¿S TOTAL LENGTH WAS CONFIRMED AND SHOULD NOT BE MISSING, BUT WANTED US

  Patient problems: Foreign Body In Patient

  MAUDE report 20791564 ↗
• 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 ↗
• MalfunctionOct 16, 2024Material 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 NEEDLE HAD BEEN DETACHED FROM THE SUTURE. 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 20464186 ↗

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