ETHIBOND EXCEL PXX52Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705031049338), received between Jul 18, 2018 and Aug 8, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THE SPEC OF PLEDGET IS DIFFERENT FROM SPEC SHOWN ON THE PACKAGE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22749348 ↗
• MalfunctionApr 24, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE WHITE NEEDLES POPPED OFF DURING SURGERY. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19174384 ↗
• MalfunctionApr 24, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE WHITE NEEDLES POPPED OFF DURING SURGERY. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19174382 ↗
• MalfunctionJan 10, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND SUTURE WAS USED. DURING TYING, THE NEEDLE CAME LOOSE FROM THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16132108 ↗
• MalfunctionJun 9, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, THE NEEDLE HAD BEEN FOUND PUNCTURED OUT OF THE PACKAGE WHICH THE PACKAGE WAS NOT STERILE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10133054 ↗
• MalfunctionMar 30, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2020 AND THE SUTURE WAS USED. IT WAS REPORTED THAT DURING PROCEDURE GREEN NEEDLE POPPED OFF DEVICE, WHITE PLEDGES DEFORMED, NOT USABLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9901821 ↗
• MalfunctionJun 11, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT DIAPHRAGMATIC PLICATION BY THORACOSCOPY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE DOCTOR WAS SUTURING THE DIAPHRAGMATIC WALL, WHEN THE SUTURE BEGAN TO DISENGAGE AND FINALLY BROKE. A NEW SUTURE WAS USED TO CONTINUE THE PROCEDURE, WHICH WAS DELAYED BY 20 MINUTES. THERE WERE NO PATIENT CONSEQUENCES WERE REPORTED. THE PATIENT HAS BEEN DISCHARGED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8689882 ↗
• MalfunctionOct 31, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BENTAL PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE GREEN STRANDS WERE COMING APART. ANOTHER LIKE DEVICE WITH A DIFFERENT LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8024858 ↗
• MalfunctionOct 31, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BENTALL PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE GREEN STRANDS WERE COMING APART. ANOTHER LIKE DEVICE WITH A DIFFERENT LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8024847 ↗
• MalfunctionOct 31, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BENTAL PROCEDURE ON (B)(6) 2018, AND SUTURE WAS USED. DURING THE PROCEDURE, THE GREEN STRANDS WERE COMING APART. ANOTHER LIKE DEVICE WITH A DIFFERENT LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8024841 ↗
• MalfunctionJul 18, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HEART VALVE REPLACEMENT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS PASSING THROUGH TISSUE WHEN THE NEEDLE POPPED OFF OF THE SUTURE AT THE SWAGE. A LIKE DEVICE FROM AN ALTERNATE LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7699928 ↗
• MalfunctionJul 18, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HEART VALVE REPLACEMENT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS PASSING THROUGH TISSUE WHEN THE NEEDLE POPPED OFF OF THE SUTURE AT THE SWAGE. A LIKE DEVICE FROM AN ALTERNATE LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7699922 ↗

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.