PERMA-HAND K846HRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705031044517), received between Jun 29, 2022 and Dec 18, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (10 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 18, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE INVENTORY CLERK THAT A PRODUCT CODE K846H MH WAS ORDERED AND CUSTOMER RECEIVED CT-1. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23836739 ↗
• MalfunctionDec 18, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE INVENTORY CLERK THAT A PRODUCT CODE K846H MH WAS ORDERED AND CUSTOMER RECEIVED CT-1. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23836734 ↗
• MalfunctionDec 18, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE INVENTORY CLERK THAT A PRODUCT CODE K846H MH WAS ORDERED AND CUSTOMER RECEIVED CT-1. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23836732 ↗
• MalfunctionDec 18, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE INVENTORY CLERK THAT A PRODUCT CODE K846H MH WAS ORDERED AND CUSTOMER RECEIVED CT-1. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23836731 ↗
• MalfunctionJun 30, 2025Break; Component Misassembled; Break; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN PROCEDURE AND SUTURE WAS USED. IT WAS REPORTED THAT THE FACILITY HAS AN ORDER ISSUE, THE NEEDLE HAS CHANGED AND THEY ARE RECEIVING A BLEND OF THE OLD NEEDLE MH AND THE NEW NEEDLE CT1 WITH THE K846H. ALL OF ONE BOX IS THE MH AND ALL OF ONE BOX IS THE CT1. THE BOXES DO NOT HAVE MIXED NEEDLES. THE CUSTOMER IS STILL RECEIVING THE OLD NEEDLE. NO PATIENT HARM WAS REPORTED. PHOTOS ARE AVAILABLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22365926 ↗
• MalfunctionMay 22, 2025Component Misassembled; Component Misassembled

  A CATHLAB INVENTORY CLERK REPORTED NOTICING A CHANGE IN NEEDLE FOR A COMMON SUTURE THEY USE. THE CONTACT STATED THAT PREVIOUSLY THE SUTURE CAME ON A MH NEEDLE HOWEVER THIS TIME IT HAD BEEN SHIPPED WITH A CT-1 NEEDLE. NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22070118 ↗
• MalfunctionMay 22, 2025Component Misassembled; Component Misassembled

  A CATHLAB INVENTORY CLERK REPORTED NOTICING A CHANGE IN NEEDLE FOR A COMMON SUTURE THEY USE. THE CONTACT STATED THAT PREVIOUSLY THE SUTURE CAME ON A MH NEEDLE HOWEVER THIS TIME IT HAD BEEN SHIPPED WITH A CT-1 NEEDLE. NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22070111 ↗
• MalfunctionDec 28, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE END USER ORDERED AND RECEIVED ONE BOX OF THE PRODUCT, WHICH SHOULD BE ON AN MH NEEDLE, BUT IT SAYS CT-1 NEEDLE ON THE BOX. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16062501 ↗
• MalfunctionSep 30, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN HEART PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING OR SET UP, THE BOX CONTAINED A CERTAIN NEEDLE BUT SHOULD HAVE BEEN ANOTHER NEEDLE. SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15513542 ↗
• MalfunctionSep 30, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN HEART PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING OR SET UP, THE BOX CONTAINED A CERTAIN NEEDLE BUT SHOULD HAVE BEEN ANOTHER NEEDLE. SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15513448 ↗
• MalfunctionSep 30, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN HEART PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING OR SET UP, THE BOX CONTAINED A CERTAIN NEEDLE BUT SHOULD HAVE BEEN ANOTHER NEEDLE. SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15513447 ↗
• MalfunctionSep 30, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN HEART PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING OR SET UP, THE BOX CONTAINED A CERTAIN NEEDLE BUT SHOULD HAVE BEEN ANOTHER NEEDLE. SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15513376 ↗
• MalfunctionJun 29, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT THE CUSTOMER HAS RECEIVED THEIR ORDER OF SILK SUTURES WITH THE SELECTION OF MH NEEDLE TYPE, BUT THEY RECEIVED CT-1 NEEDLE TYPE INSTEAD. IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14862834 ↗
• MalfunctionJun 29, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT THE CUSTOMER HAS RECEIVED THEIR ORDER OF SILK SUTURES WITH THE SELECTION OF MH NEEDLE TYPE, BUT THEY RECEIVED CT-1 NEEDLE TYPE INSTEAD. IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14862726 ↗
• MalfunctionJun 29, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT THE CUSTOMER HAS RECEIVED THEIR ORDER OF SILK SUTURES WITH THE SELECTION OF MH NEEDLE TYPE, BUT THEY RECEIVED CT-1 NEEDLE TYPE INSTEAD. IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14862528 ↗

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-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.