ETHIBOND EXCEL CX21DRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10705031024229), received between Mar 13, 2020 and Dec 30, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Material Separation” (18 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PACEMAKER PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A LEAD REVISION OF THE PACEMAKER, SLACK FELL OUT IN TWO DIFFERENT PATIENTS. AT THE END OF THE CASE, FLUOROSCOPY OF THE CHEST REVEALED THAT THE SLACK HAD PULLED BACK SIGNIFICANTLY. THE SURGEON HAD TO RE-SUTURE THE SLEEVES, RESULTING IN AN APPROXIMATE FIVE-MINUTE DELAY IN THE SURGERY. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23921145 ↗
• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PACEMAKER PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A LEAD REVISION OF THE PACEMAKER, SLACK FELL OUT IN TWO DIFFERENT PATIENTS. AT THE END OF THE CASE, FLUOROSCOPY OF THE CHEST REVEALED THAT THE SLACK HAD PULLED BACK SIGNIFICANTLY. THE SURGEON HAD TO RE-SUTURE THE SLEEVES, RESULTING IN AN APPROXIMATE FIVE-MINUTE DELAY IN THE SURGERY. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23921122 ↗
• MalfunctionJun 5, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL SHOULDER REPLACEMENT PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THERE APPEARS TO BE BLOOD OR RUST ON THE NEEDLE. CASE WAS COMPLETED WITH A LIKE DEVICE OF THE SAME LOT NUMBER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22148987 ↗
• MalfunctionDec 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN NOVEMBER 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, PER USER FACILITY MEDWATCH FORM, #(B)(4), DURING AN UNKNOWN PROCEDURE; SURGEON WAS USING A PACK OF 0 ETHIBOND EXCEL POLYESTER SUTURE "POPS", THAT COMES IN AN EIGHT PACK. THESE SUTURES ARE DESIGNED TO RELEASE FROM THE NEEDLE UNDER A CERTAIN AMOUNT OF TENSION. HE STATES THAT THIS PACK SEEMED TO RELEASE UNDER LESS THAN USUAL TENSION, ALTERING HIS SUTURE PROCESS, AND ONE NEEDLE CAME FREE FROM THE SUTURE AND FELL TO THE FLOOR, PRESENTING A SAFETY CONCERN OF POSSIBLE MISHANDLING. NO INJURY OCCURRED, BUT HE STATES THIS HAS BEEN HAPPENING RECENTLY WITH OTHER PACKS OF THIS SAME TYPE OF SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE AVAILABILITY UNKNOWN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21039519 ↗
• MalfunctionDec 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, PER USER FACILITY MEDWATCH FORM, # (B)(4), DURING AN UNKNOWN PROCEDURE; SURGEON WAS USING A PACK OF 0 ETHIBOND EXCEL POLYESTER SUTURE "POPS", THAT COMES IN AN EIGHT PACK. THESE SUTURES ARE DESIGNED TO RELEASE FROM THE NEEDLE UNDER A CERTAIN AMOUNT OF TENSION. HE STATES THAT THIS PACK SEEMED TO RELEASE UNDER LESS THAN USUAL TENSION, ALTERING HIS SUTURE PROCESS, AND ONE NEEDLE CAME FREE FROM THE SUTURE AND FELL TO THE FLOOR, PRESENTING A SAFETY CONCERN OF POSSIBLE MISHANDLING. NO INJURY OCCURRED, BUT HE STATES THIS HAS BEEN HAPPENING RECENTLY WITH OTHER PACKS OF THIS SAME TYPE OF SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE AVAILABILITY UNKNOWN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21039484 ↗
• MalfunctionMar 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE PULLED OFF THE SUTURE RIGHT AWAY AND PRODUCT COULD NOT BE USED. IT WAS REPORTED THE ISSUE OCCURRED DURING SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9831687 ↗
• MalfunctionMar 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE PULLED OFF THE SUTURE RIGHT AWAY AND PRODUCT COULD NOT BE USED. IT WAS REPORTED THE ISSUE OCCURRED DURING SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9831681 ↗
• MalfunctionMar 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE PULLED OFF THE SUTURE RIGHT AWAY AND PRODUCT COULD NOT BE USED. IT WAS REPORTED THE ISSUE OCCURRED DURING SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9831680 ↗
• MalfunctionMar 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE PULLED OFF THE SUTURE RIGHT AWAY AND PRODUCT COULD NOT BE USED. IT WAS REPORTED THE ISSUE OCCURRED DURING SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9831679 ↗
• MalfunctionMar 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE PULLED OFF THE SUTURE RIGHT AWAY AND PRODUCT COULD NOT BE USED. IT WAS REPORTED THE ISSUE OCCURRED DURING SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9831678 ↗
• MalfunctionMar 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE PULLED OFF THE SUTURE RIGHT AWAY AND PRODUCT COULD NOT BE USED. IT WAS REPORTED THE ISSUE OCCURRED DURING SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9831673 ↗
• MalfunctionMar 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE PULLED OFF THE SUTURE RIGHT AWAY AND PRODUCT COULD NOT BE USED. IT WAS REPORTED THE ISSUE OCCURRED DURING SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9831672 ↗
• MalfunctionMar 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE PULLED OFF THE SUTURE RIGHT AWAY AND PRODUCT COULD NOT BE USED. IT WAS REPORTED THE ISSUE OCCURRED DURING SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9831666 ↗
• MalfunctionMar 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE PULLED OFF THE SUTURE RIGHT AWAY AND PRODUCT COULD NOT BE USED. IT WAS REPORTED THE ISSUE OCCURRED DURING SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9831662 ↗
• MalfunctionMar 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE PULLED OFF THE SUTURE RIGHT AWAY AND PRODUCT COULD NOT BE USED. IT WAS REPORTED THE ISSUE OCCURRED DURING SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9831661 ↗
• MalfunctionMar 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE PULLED OFF THE SUTURE RIGHT AWAY AND PRODUCT COULD NOT BE USED. IT WAS REPORTED THE ISSUE OCCURRED DURING SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9831659 ↗
• MalfunctionMar 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE PULLED OFF THE SUTURE RIGHT AWAY AND PRODUCT COULD NOT BE USED. IT WAS REPORTED THE ISSUE OCCURRED DURING SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9831658 ↗
• MalfunctionMar 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE PULLED OFF THE SUTURE RIGHT AWAY AND PRODUCT COULD NOT BE USED. IT WAS REPORTED THE ISSUE OCCURRED DURING SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9831657 ↗
• MalfunctionMar 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE PULLED OFF THE SUTURE RIGHT AWAY AND PRODUCT COULD NOT BE USED. IT WAS REPORTED THE ISSUE OCCURRED DURING SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9831656 ↗
• MalfunctionMar 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE PULLED OFF THE SUTURE RIGHT AWAY AND PRODUCT COULD NOT BE USED. IT WAS REPORTED THE ISSUE OCCURRED DURING SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9831655 ↗
• MalfunctionMar 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE PULLED OFF THE SUTURE RIGHT AWAY AND PRODUCT COULD NOT BE USED. IT WAS REPORTED THE ISSUE OCCURRED DURING SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9831651 ↗

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.