MERSILENE RS21Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031049789), received between Dec 28, 2018 and Jan 5, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 reports).

9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND TAPE WAS USED. WHILE DOING THE PROCEDURE NEEDLE GOT DETACHED FROM THE TAPE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23958065 ↗
• MalfunctionOct 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CERVICAL CERCLAGE SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, AT AROUND 12:00, THE OPERATING ROOM DOCTOR PERFORMED A SURGERY USING A SUTURE TAPE. AFTER CHECKING FOR ANY ABNORMALITIES, THE OPERATION WAS CARRIED OUT NORMALLY. HOWEVER, DURING THE SURGERY, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, CAUSING THE SURGERY TO BE INTERRUPTED. THE SUTURED SUTURE TAPE MUST NOT BE REMOVED, AND THE NEEDLE AND SUTURE MUST BE REPLACED TO PERFORM THE SURGERY AGAIN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23222732 ↗
• MalfunctionNov 15, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE TAPE WAS DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15802471 ↗
• InjuryDec 28, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: TRANSLOCATION OF A CERCLAGE BAND INTO THE ENDOCERVICAL CANAL AFTER PRECONCEPTION TRANSABDOMINAL CERVICO-ISTHMIC CERCLAGE" AUTHORS: MOON-IL PARK AND JEONG-KYU HOH. CITATION: J. OBSTET. GYNAECOL. RES. VOL. 36, NO. 1: 209¿212, FEBRUARY 2010; DOI:10.1111/J.1447-0756.2009.01097.X. THIS STUDY AIMED TO PRESENT A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD HISTORY OF FIVE SPONTANEOUS LOSSES AND FAILURE OF TWO MCDONALD PURSE-STRING CERCLAGES, WHO UNDERWENT TRANSABDOMINAL CERVICO-ISTHMIC CERCLAGE (TCC) FOR INCOMPETENT CERVIX AS A MANAGEMENT OF RECURRENT SECOND-TRIMESTER PREGNANCY LOSS AND PRETERM DELIVERY. IN THE PROCEDURE, THE POSTERIOR PERITONEUM WAS PUNCTURED WITH AN ANEURYSM NEEDLE, PASSING A SINGLE STRIP OF #5 MERSILENE BAND (0.5 CM WIDE, MERSILENE 5, RS21, ETHICON, INC. NJ, USA) FROM THE POSTERIOR TO THE ANTERIOR SIDE. THE PROCEDURE THEN WAS REPEATED ON THE CONTRALATERAL SIDE USING THE SAME PIECE OF MERSILENE BAND. THE MERSILENE BAND WAS ADJUSTED TO LIE FLAT OVER THE POSTERIOR PERITONEUM AT THE LEVEL OF THE ORIGIN OF THE UTEROSACRAL LIGAMENTS. THEN IT WAS TIED ANTERIORLY CAUSING COMPRESSION WITHOUT UNDUE CONSTRICTION OF THE INTERVENING TISSUE. HER

  Patient problems: Erosion; Not Applicable; Premature Labor

  MAUDE report 8204371 ↗

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-0153-2027 · Sep 8, 2026 · Open, Classified
  PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H
• 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
• 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
• 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 approx
• 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.