ETHIBOND EXCEL X843HRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031058088), received between Aug 29, 2018 and Nov 4, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

7 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.

Recalls naming this device

1. Mar 7, 2025Open, Classified

   Identified curing issues with the silicone during the needles manufacturing process.

   Z-1516-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED BEFORE USE ON THE PATIENT THAT UPON GETTING A STOCK OF X582H, THEY FOUND 5 PCS OF X843 IN THE SAME BOX OF X582H. THE NURSE REPORTED THAT THERE HAS BEEN 5 X843 CODE OF ETHIBOND WHICH IS SOMETHING THEY DON'T USE AND IS NOT AVAILABLE HERE IN PH AND WAS FOUND IN THE BOX OF X582H. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15740719 ↗
• MalfunctionNov 4, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED BEFORE USE ON THE PATIENT THAT UPON GETTING A STOCK OF X582H, THEY FOUND 5 PCS OF X843 IN THE SAME BOX OF X582H. THE NURSE REPORTED THAT THERE HAS BEEN 5 X843 CODE OF ETHIBOND WHICH IS SOMETHING THEY DON'T USE AND IS NOT AVAILABLE HERE IN PH AND WAS FOUND IN THE BOX OF X582H. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15740718 ↗
• MalfunctionNov 4, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED BEFORE USE ON THE PATIENT THAT UPON GETTING A STOCK OF X582H, THEY FOUND 5 PCS OF X843 IN THE SAME BOX OF X582H. THE NURSE REPORTED THAT THERE HAS BEEN 5 X843 CODE OF ETHIBOND WHICH IS SOMETHING THEY DON'T USE AND IS NOT AVAILABLE HERE IN PH AND WAS FOUND IN THE BOX OF X582H. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15740270 ↗
• MalfunctionNov 4, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED BEFORE USE ON THE PATIENT THAT UPON GETTING A STOCK OF X582H, THEY FOUND 5 PCS OF X843 IN THE SAME BOX OF X582H. THE NURSE REPORTED THAT THERE HAS BEEN 5 X843 CODE OF ETHIBOND WHICH IS SOMETHING THEY DON'T USE AND IS NOT AVAILABLE HERE IN PH AND WAS FOUND IN THE BOX OF X582H. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15740061 ↗
• MalfunctionNov 4, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED BEFORE USE ON THE PATIENT THAT UPON GETTING A STOCK OF X582H, THEY FOUND 5 PCS OF X843 IN THE SAME BOX OF X582H. THE NURSE REPORTED THAT THERE HAS BEEN 5 X843 CODE OF ETHIBOND WHICH IS SOMETHING THEY DON'T USE AND IS NOT AVAILABLE HERE IN PH AND WAS FOUND IN THE BOX OF X582H. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15739783 ↗
• MalfunctionAug 29, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT AND REPAIR OF ASCENDING AORTIC ANEURYSM ON (B)(6) 2018 AND SUTURE WAS USED. WHILE THE SURGEON WAS SUTURING IN THE GRAFT, THE NEEDLE POPPED OFF OF THE SUTURE AND WAS LOST INSIDE THE AORTA. IT WAS LATER FOUND WHEN THE NEEDLE STUCK THE SURGEON IN HIS FINGER AS HE WAS FEELING THE BACKSIDE OF THE AORTA WITH HIS FINGER. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7826796 ↗

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-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 app
• 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-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.