ETHICON D9499Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705031033313), received between Jul 24, 2019 and Dec 24, 2019 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Material Separation” (15 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 24, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2019 AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE DESWAGED DURING ROUTINE USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9516936 ↗
• MalfunctionNov 8, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE DESWAGED DURING ROUTINE USE. CHANGED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9295785 ↗
• MalfunctionNov 8, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE DESWAGED DURING ROUTINE USE. CHANGED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9295781 ↗
• MalfunctionNov 8, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE DESWAGED DURING ROUTINE USE. CHANGED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9295777 ↗
• MalfunctionNov 8, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE DESWAGED DURING ROUTINE USE. CHANGED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9295773 ↗
• MalfunctionNov 1, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2019 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE DESWAGED DURING ROUTINE USE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9268692 ↗
• MalfunctionNov 1, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2019 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE DESWAGED DURING ROUTINE USE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9268671 ↗
• MalfunctionNov 1, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2019 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE DESWAGED DURING ROUTINE USE. WHEN THE FIRST ONE CAME OFF THE NEEDLE DRIVER, HIS HAND FLEW UP TO HIT HIM IN HIS FACE / SURGICAL GLASSES, CONTAMINATING THE INSTRUMENT AS WELL AS HIS GLOVE / GOWN. HE HAD TO LEAVE THE OR TO CLEAN HIS GLASSES / RESCRUB AND RE GOWN / GLOVE. THIS POTENTIALLY CONTAMINATED THE OPERATIVE FIELD AND DELAYED THE CASE. FORTUNATELY THE NEEDLE DRIVER DID NOT INJURE HIS FACE BECAUSE IT HIT THE SURGICAL GLASSES INSTEAD. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9268643 ↗
• MalfunctionNov 1, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2019 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE DESWAGED DURING ROUTINE USE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9268642 ↗
• MalfunctionOct 30, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE SUTURE UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE PREMATURELY RELEASED FROM THE SUTURE STRAND DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9256771 ↗
• MalfunctionJul 24, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OPEN HEART SURGERY ON (B)(6) 2019. DURING THE PROCEDURE, THE NEEDLE CAME OFF OF THE WIRE. AN ALTERNATE DEVICE FROM A DIFFERENT BOX WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8824124 ↗
• MalfunctionJul 24, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OPEN HEART SURGERY ON (B)(6) 2019. DURING THE PROCEDURE, THE NEEDLE CAME OFF OF THE WIRE. AN ALTERNATE DEVICE FROM A DIFFERENT BOX WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8824103 ↗
• MalfunctionJul 24, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OPEN HEART SURGERY ON (B)(6) 2019. DURING THE PROCEDURE, THE NEEDLE CAME OFF OF THE WIRE. AN ALTERNATE DEVICE FROM A DIFFERENT BOX WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8824102 ↗
• MalfunctionJul 24, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OPEN HEART SURGERY ON (B)(6) 2019. DURING THE PROCEDURE, THE NEEDLE CAME OFF OF THE WIRE. AN ALTERNATE DEVICE FROM A DIFFERENT BOX WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8824101 ↗
• MalfunctionJul 24, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OPEN HEART SURGERY ON (B)(6) 2019. DURING THE PROCEDURE, THE NEEDLE CAME OFF OF THE WIRE. AN ALTERNATE DEVICE FROM A DIFFERENT BOX WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8824096 ↗

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.