MERSILENE RS23Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705031049826), received between May 8, 2019 and May 27, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE SURGEON TO THE SALES REP THAT DURING AN UNKNOWN PROCEDURE, THE NEEDLE POPPED RIGHT OFF WITH MINIMAL TENSION AND IT HAPPENED TWICE ON THE SAME PROCEDURE. NO PATIENT CONSEQUENCES. DEVICE WILL BE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25299144 ↗
• MalfunctionMay 27, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE SURGEON TO THE SALES REP THAT DURING AN UNKNOWN PROCEDURE, THE NEEDLE POPPED RIGHT OFF WITH MINIMAL TENSION AND IT HAPPENED TWICE ON THE SAME PROCEDURE. NO PATIENT CONSEQUENCES. DEVICE WILL BE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25299142 ↗
• MalfunctionApr 29, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CERCLAGE PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT TO THE SALES REP THAT DURING A CERCLAGE PROCEDURE, THE NEEDLES COMING OFF TOO EASILY. NO PATIENT CONSEQUENCES. DEVICE WILL BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25033308 ↗
• MalfunctionFeb 6, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE AHS THAT DURING A CERCLAGE PROCEDURE, WHEN NURSE LOADED SUTURE, THE WHITE SUTURE MATERIAL ATTACHED TO THE NEEDLE CAME APART. THE NEEDLE AND THE WHITE SUTURE MATERIAL WERE SEPARATED. THE ISSUE OCCURRED MULTIPLE TIMES. NO OTHER DETAILS PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279844 ↗
• MalfunctionFeb 6, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE AHS THAT DURING A CERCLAGE PROCEDURE, WHEN NURSE LOADED SUTURE, THE WHITE SUTURE MATERIAL ATTACHED TO THE NEEDLE CAME APART. THE NEEDLE AND THE WHITE SUTURE MATERIAL WERE SEPARATED. THE ISSUE OCCURRED MULTIPLE TIMES. NO OTHER DETAILS PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279843 ↗
• MalfunctionFeb 6, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE AHS THAT DURING A CERCLAGE PROCEDURE, WHEN NURSE LOADED SUTURE, THE WHITE SUTURE MATERIAL ATTACHED TO THE NEEDLE CAME APART. THE NEEDLE AND THE WHITE SUTURE MATERIAL WERE SEPARATED. THE ISSUE OCCURRED MULTIPLE TIMES. NO OTHER DETAILS PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279836 ↗
• MalfunctionFeb 2, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CERCLAGE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE AHS THAT DURING A CERCLAGE PROCEDURE, WHEN NURSE LOADED SUTURE, THE WHITE SUTURE MATERIAL ATTACHED TO THE NEEDLE CAME APART. THE NEEDLE AND THE WHITE SUTURE MATERIAL WERE SEPARATED. THE ISSUE OCCURRED MULTIPLE TIMES. NO OTHER DETAILS PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24234801 ↗
• MalfunctionFeb 2, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CERCLAGE PROCEDURE ON (B)(6)2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE AHS THAT DURING A CERCLAGE PROCEDURE, WHEN NURSE LOADED SUTURE, THE WHITE SUTURE MATERIAL ATTACHED TO THE NEEDLE CAME APART. THE NEEDLE AND THE WHITE SUTURE MATERIAL WERE SEPARATED. THE ISSUE OCCURRED MULTIPLE TIMES. NO OTHER DETAILS PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24234380 ↗
• MalfunctionJan 14, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24072257 ↗
• MalfunctionJan 14, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24072251 ↗
• MalfunctionAug 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CERVICAL CERCLAGE PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE NEEDLE BROKE OFF DURING THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19996481 ↗
• MalfunctionAug 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CERVICAL CERCLAGE PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE NEEDLE BROKE OFF DURING THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19996474 ↗
• InjuryFeb 7, 2024Material Separation; Insufficient Device Problem Information; Material Separation; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CERVICAL CERCLAGE PLACEMENT ON AN UNKNOWN DATE AND SUTURE TAPE WAS USED. THE SURGEON PASSED THE SUTURE A COUPLE OF TIMES AND THEN THE NEEDLE POPPED OFF THE SUTURE AS SURGEON WAS PULLING THE SUTURE. SURGEON HAD TO REMOVE AND START OVER WHICH CAUSED BLEEDING DUE TO BEING HIGHLY VASCULAR. BLOOD LOSS OF 80. SURGEON USED NEW BOX WITH DIFFERENT LOT AND WAS ABLE TO FINISH THE CASE. PATIENT WOULD HAVE WENT HOME SAME DAY BUT WILL NOW HAVE TO STAY OVERNIGHT FOR MONITORING DUE TO BLOOD LOSS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18662083 ↗
• MalfunctionMay 8, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT GYNECOLOGICAL PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE CERVICAL CERCLAGE, THE NEEDLE BROKE IN HALF PASSING THROUGH THE CERVIX. BOTH PIECES WERE RETRIEVED WITHOUT FURTHER INCIDENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8591861 ↗

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.