MERSILENE RS22Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10705031049802), received between Mar 12, 2018 and Sep 9, 2026 — classified as 6 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Material Separation” (25 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 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50699100 ↗
• MalfunctionSep 9, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50699097 ↗
• MalfunctionDec 30, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CERVICAL CERCLAGE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23922376 ↗
• MalfunctionDec 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CERCLAGE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888293 ↗
• MalfunctionSep 19, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. PRIOR TO USING THE SUTURE IT WAS NOTED THAT THE NEEDLE TIP WAS INCORRECT NEEDLE SHAPE. ACTION: DISCARDED THE SUTURE AND OPEN ANOTHER SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23094968 ↗
• MalfunctionSep 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CERVICAL CERCLAGE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PATIENT UNDERWENT SURGERY AT 14:42 DUE TO PREGNANCY COMPLICATED WITH CERVICAL DYSFUNCTION. DURING THE SURGERY, THE DOCTOR USED A SUTURE TAPE TO SUTURE THE CERVIX, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED AND COULD NOT CONTINUE SUTURING. THE DOCTOR PASSED THE NEEDLE THROUGH THE SUTURE TAPE, CONTINUED SUTURING, AND COMPLETED THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963080 ↗
• MalfunctionAug 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CERVICAL CERCLAGE UNDER LAPAROSCOPY ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHEN SEWING DURING THE SURGERY. THE NEEDLE DID NOT FALL INTO THE PATIENT. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860316 ↗
• MalfunctionApr 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A A SURGICAL PROCEDURE TO INSERT A CERCLAGE ON (B)(6) 2025 AND SUTURE WAS USED. THE DESCRIPTION OF THE COMPLAINT WAS THAT THE SUTURE MATERIAL CAME AWAY FROM THE NEEDLE DURING SURGERY. THE EVENT WAS MANAGED WITHOUT ANY CONSEQUENCES TO THE PATIENT AS THE SURGEON WAS ABLE TO USE THE OTHER END OF THE SUTURE TO CLOSE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21862019 ↗
• MalfunctionMar 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21548503 ↗
• MalfunctionFeb 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC UTERINE ISTHMUS CERCLAGE SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PATIENT'S VAGINAL CERVICAL CERCLAGE FAILED, AND SUTURE WAS USED DURING THE LAPAROSCOPIC UTERINE ISTHMUS CERCLAGE SURGERY. DURING THE SURGERY, WHEN THE NEEDLE HAD COMPLETELY PENETRATED THE TISSUE OF THE UTERINE ISTHMUS, THE SUTURE SLIGHTLY EXPOSED THE TISSUE. THE DOCTOR CONTINUED TO PULL THE SUTURE OUT OF THE TISSUE BY PULLING THE NEEDLE BODY, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. IMMEDIATELY, A NEEDLE HOLDER WAS USED TO STRAIGHTEN THE NEEDLE BODY AND REMOVE IT. THE SUTURE THAT LEAKED OUT OF THE ORGANIZATION WAS RELATIVELY SHORT, AND THE DOCTOR CONTINUED TO PULL THE EXPOSED SHORT HEAD TO PULL OUT THE SUTURE AND TIE IT. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN THIS CASE IS CONSIDERED FORTUNATE. IF THE SUTURE SOMETIMES DETACHES BEFORE IT PENETRATES THE TISSUE, IT MAY REQUIRE A SECOND PUNCTURE FOR THE PATIENT, RESULTING IN INCREASED BLEEDING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21427744 ↗
• MalfunctionJan 17, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN LAPAROSCOPE PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. WHEN THE OPERATOR WAS USING IT, THE FIXATION BECAME LOOSE DUE TO THE THREAD LOOSENING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21179312 ↗
• MalfunctionNov 20, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN THE SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THE NEEDLE DID NOT FELL INTO THE PATIENT. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20737081 ↗
• MalfunctionJul 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19838746 ↗
• MalfunctionMay 15, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A VAGINAL CERCLAGE ON AN UNKNOWN DATE IN 2024 AND A SUTURE TAPE WAS USED. THE SUTURE KEPT PULLING OFF THE SUTURE. THE REST OF THE CASE WAS COMPLETED WITHOUT PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19322535 ↗
• MalfunctionApr 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE THAT THREE NEEDLES POPPED OFF WHILE SUTURING. ANOTHER LIKE SUTURE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19111325 ↗
• MalfunctionApr 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE THAT THREE NEEDLES POPPED OFF WHILE SUTURING. ANOTHER LIKE SUTURE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19106834 ↗
• MalfunctionApr 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE THAT THREE NEEDLES POPPED OFF WHILE SUTURING. ANOTHER LIKE SUTURE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19106830 ↗
• MalfunctionFeb 16, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CERVICAL CERCLAGE PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT THE NEEDLE HAD BEEN FOUND BROKEN BEFORE USING ON PATIENT . VISUAL INSPECTION AND METALLURGICAL ANALYSIS WERE PERFORMED ON THE RETURNED PRODUCT. A FRACTURE WAS OBSERVED AT THE SUTURE ATTACHMENT OF THE NEEDLE. THE NEEDLE WAS RECEIVED IN TWO PIECES, ONLY ONE OF THE MATING FRACTURE SURFACES WAS EXAMINED FOR THIS EVALUATION. THE NEEDLE WAS NOTED WITH MARKS THAT APPEARS TO BE BY SURGICAL INSTRUMENT. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18722227 ↗
• MalfunctionDec 19, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND TAPE WAS USED. THE NEEDLE WAS FOUND BROKEN WHEN IT WAS OPENED TO PREPARE FOR THE SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THE LOT IS UNAVAILABLE. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. UPON RECEIPT AND ANALYSIS, IN WAS OBSERVED A NEEDLE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18357013 ↗
• MalfunctionSep 7, 2023Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT THE PRIMARY PACKAGE OF THE SUTURE WAS FOUND DAMAGED PRIOR TO USE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17699047 ↗
• MalfunctionMay 24, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PATIENT UNDERWENT SURGERY DUE TO PREGNANCY COMBINED WITH CERVICAL INCOMPETENCE. DURING THE SURGERY, THE NEEDLE BROKE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16998728 ↗
• MalfunctionJan 3, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE BROKE WHEN SEWING IN AN UNKNOWN SURGERY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16092053 ↗
• MalfunctionJan 3, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE BROKE WHEN SEWING IN AN UNKNOWN SURGERY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16092052 ↗
• MalfunctionDec 23, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE ON (B)(6) 2022 AND SUTURE TAPE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16042781 ↗
• MalfunctionDec 23, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE ON (B)(6) 2022 AND SUTURE TAPE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16041754 ↗

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.