Coated VICRYL J426HRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10705031039773), received between Sep 22, 2017 and Apr 24, 2025 — classified as 7 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Material Separation” (10 reports).

3 other recalls cover devices cleared under the same FDA submission (K022269); 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, FOUND DOUBLE ARMED SUTURE - TWO NEEDLES IN A PACKAGE THAT SHOULD HAVE ONE, PRODUCT CODE: J426H. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21901332 ↗
• MalfunctionApr 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN HEART PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE KEPT POPPING OFF. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19063841 ↗
• MalfunctionMar 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN HEART PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE KEPT POPPING OFF. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18866467 ↗
• MalfunctionNov 16, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE THAT THE NEEDLE KEPT POPPING OFF AT THE SWEDGED WITH VERY LITTLE FORCE. A TOTAL OF FIVE SUTURES WERE USED DURING THE PROCEDURE WHEN NORMALLY IT ONLY TAKES ONE. THE FIFTH SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18149123 ↗
• MalfunctionNov 16, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE THAT THE NEEDLE KEPT POPPING OFF AT THE SWEDGED WITH VERY LITTLE FORCE. A TOTAL OF FIVE SUTURES WERE USED DURING THE PROCEDURE WHEN NORMALLY IT ONLY TAKES ONE. THE FIFTH SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18149121 ↗
• MalfunctionNov 16, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE THAT THE NEEDLE KEPT POPPING OFF AT THE SWEDGED WITH VERY LITTLE FORCE. A TOTAL OF FIVE SUTURES WERE USED DURING THE PROCEDURE WHEN NORMALLY IT ONLY TAKES ONE. THE FIFTH SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18149103 ↗
• MalfunctionNov 16, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE THAT THE NEEDLE KEPT POPPING OFF AT THE SWEDGED WITH VERY LITTLE FORCE. A TOTAL OF FIVE SUTURES WERE USED DURING THE PROCEDURE WHEN NORMALLY IT ONLY TAKES ONE. THE FIFTH SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18149098 ↗
• MalfunctionAug 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DISTRIBUTOR BY THE CUSTOMER THAT THE SCRUB TECH HANDED SUTURE TO SURGEON FOR SURGEON TO CLOSE SKIN. SURGEON STARTED TO USE SUTURE. WHEN SUTURE WAS PULLED THROUGH, PART OF THE STRING OF THE SUTURE FELL OFF FROM THE REST. SURGEON NOTIFIED SCRUB TECH WHO NOTIFIED CIRCULATOR AND MANAGEMENT. SUTURES WITH SAME LOT NUMBER TAKEN OFF SHELF IN SET-UPS, MANAGER OF SET-UPS NOTIFIED ALSO. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17547386 ↗
• InjuryMay 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT PRESENTED WITH AN ALLERGIC REACTION AND OR AN INFECTION TO THE SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Unspecified Infection

  MAUDE report 16947698 ↗
• InjuryMay 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT PRESENTED WITH AN ALLERGIC REACTION AND OR AN INFECTION TO THE SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Unspecified Infection

  MAUDE report 16947697 ↗
• MalfunctionSep 22, 2021Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN GYN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN CLOSING THE SUBCUTICULAR LAYER, IT WAS NOTICED THAT THE NEEDLE DID NOT HAVE A TIP. IT WAS REPORTED TO BE MISSING BEFORE REMOVED FROM PACKAGE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12513205 ↗
• MalfunctionJul 28, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IMPLANTATION OF A HIS BUNDLE PACEMAKER PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, UPON SUTURING THE PACEMAKER POCKET, THE DOCTOR NOTICED THE SUTURE DID NOT HAVE A SHARP TIP. HE IMMEDIATELY STOPPED SUTURING. HE INSPECTED THE POCKET FOR A POSSIBLE SUTURE/NEEDLE TIP. HE THEN RE-OPENED THE POCKET TO VERIFY NO TIP WAS IN THE POCKET. NO TIP FOUND. HE PROCEEDED TO X-RAY/FLUORO THE POCKET, AS IT WOULD BE VISIBLE UNDER X-RAY, NO TIP. THE DOCTOR PROCEEDED TO USE A STERILE MAGNET OVER THE POCKET AS A FURTHER MEASURE TO ENSURE NO TIP WAS THERE, AS THERE WAS NOT. AFTER INVESTIGATION OF THE POCKET, IT WAS DETERMINED THERE WAS NO LOST TIP. THE DOCTOR OPINED THAT THE NEEDLE TIP MAY HAVE BEEN BLUNT TO BEGIN WITH. THE SUTURE WAS PLACED IN A SPECIMEN CUP AND LABELED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. UPON EVALUATION OF THE RETURNED DEVICE, A FRACTURE WAS OBSERVED AT THE TIP OF THE NEEDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10331660 ↗
• MalfunctionJan 14, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF AT THE SWAGE IN SUBCUTANEOUS TISSUE. THE NEEDLE WAS FISHED OUT USING A BOVIE. THE PROCEDURE WAS COMPLETED WITH A LIKE DEVICE WITH NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9587074 ↗
• MalfunctionDec 18, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CHEST PORT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE DOCTOR USED A COMBINATION OF 4-0 SUTURE 2-0 POLYSORB SUTURE TO SUTURE INNER AND OUTER LAYERS OF TISSUE FOR A CHEST PORT. THE PATIENT WAS DISCHARGED AND RETURNED AN UNKNOWN NUMBER OF DAYS LATER WITH UNKNOWN ISSUES WITH THE CHEST PORT AND THE ABSORBABLE SUTURE WASN¿T ABSORBING. IT WAS NOT REPORTED HOW THE PATIENT WAS TREATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9489775 ↗
• MalfunctionDec 18, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED TO SUTURE INNER AND OUTER LAYERS OF TISSUE FOR A CHEST PORT. A MEDTRONIC POLYSORB SUTURE WAS ALSO USED CONCOMITANTLY. THE PATIENT WAS DISCHARGED AND RETURNED AN UNKNOWN NUMBER OF DAYS LATER WITH UNKNOWN ISSUES WITH THE CHEST PORT AND THE ABSORBABLE SUTURE WASN¿T ABSORBING. IT WAS NOT REPORTED HOW THE PATIENT WAS TREATED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9489721 ↗
• MalfunctionDec 18, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED TO SUTURE INNER AND OUTER LAYERS OF TISSUE FOR A CHEST PORT. A MEDTRONIC POLYSORB SUTURE WAS ALSO USED CONCOMITANTLY. THE PATIENT WAS DISCHARGED AND RETURNED AN UNKNOWN NUMBER OF DAYS LATER WITH UNKNOWN ISSUES WITH THE CHEST PORT AND THE ABSORBABLE SUTURE WASN'T ABSORBING. IT WAS NOT REPORTED HOW THE PATIENT WAS TREATED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9489500 ↗
• InjuryDec 17, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SUTURE OF CHEST PORT ON (B)(6) 2019 AND SUTURE WAS USED ON INNER AND OUTER LAYERS OF TISSUE. THE SURGEON USED A COMBINATION OF 4-0 SUTURE AND 2-0 POLYSORB SUTURE. THE PATIENT WAS DISCHARGED AND RETURNED AN UNKNOWN NUMBER OF DAYS LATER WITH SEPSIS AROUND THE CHEST PORT AND THE ABSORBABLE SUTURES HADN'T ABSORBED. THE CHEST PORT WAS INFECTED AND HAD TO BE REMOVED. THE PATIENT RECEIVED ANTIOBIOTIC THERAPY AND WAS DISCHARGED TO A DIFFERENT FACILITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Sepsis; Unspecified Infection

  MAUDE report 9484417 ↗
• MalfunctionDec 17, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED TO SUTURE INNER AND OUTER LAYERS OF TISSUE FOR A CHEST PORT. A MEDTRONIC POLYSORB SUTURE WAS ALSO USED CONCOMITANTLY. THE PATIENT WAS DISCHARGED AND RETURNED AN UNKNOWN NUMBER OF DAYS LATER WITH UNKNOWN ISSUES WITH THE CHEST PORT AND THE ABSORBABLE SUTURE WASN¿T ABSORBING. IT WAS NOT REPORTED HOW THE PATIENT WAS TREATED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9483196 ↗
• MalfunctionDec 17, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED TO SUTURE INNER AND OUTER LAYERS OF TISSUE FOR A CHEST PORT. A MEDTRONIC POLYSORB SUTURE WAS ALSO USED CONCOMITANTLY. THE PATIENT WAS DISCHARGED AND RETURNED AN UNKNOWN NUMBER OF DAYS LATER WITH UNKNOWN ISSUES WITH THE CHEST PORT AND THE ABSORBABLE SUTURE WASN¿T ABSORBING. IT WAS NOT REPORTED HOW THE PATIENT WAS TREATED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9483186 ↗
• MalfunctionNov 14, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GENERAL SURGERY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE TIP OF THE NEEDLE BROKE OFF WHILE SUTURING DENSE TISSUE. THE DOCTOR WASN'T ABLE TO FIND THE BROKEN TIP OF THE NEEDLE. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9324081 ↗
• MalfunctionNov 14, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GENERAL SURGERY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE TIP OF THE NEEDLE BROKE OFF WHILE SUTURING DENSE TISSUE. THE DOCTOR WASN'T ABLE TO FIND THE BROKEN TIP OF THE NEEDLE. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9324046 ↗
• MalfunctionNov 14, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GENERAL SURGERY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE TIP OF THE NEEDLE BROKE OFF WHILE SUTURING DENSE TISSUE. THE DOCTOR WASN'T ABLE TO FIND THE BROKEN TIP OF THE NEEDLE. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9324039 ↗
• MalfunctionSep 11, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAP CHOLECYSTECTOMY PROCEDURE IN 2019 AND THE SUTURE WAS USED. DURING USE THE NEEDLE POPPED OFF WHEN SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9000690 ↗
• MalfunctionSep 11, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAP CHOLECYSTECTOMY PROCEDURE IN 2019 AND THE SUTURE WAS USED. DURING USE THE NEEDLE POPPED OFF WHEN SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8999108 ↗
• InjuryAug 22, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ACHILLES TENDON REPAIR AND GRAFT ON (B)(6) 2018 AND SUTURE WAS USED. ON (B)(6) 2018, THE PATIENT RETURNED DUE TO PAIN AND SWELLING. THE PATIENT WAS ADMINISTERED ANTIBIOTICS WHEN HE PRESENTED WITH ISSUES. ON (B)(6) 2018, THE PATIENT WAS BROUGHT BACK TO SURGERY FOR DEEP SUTURE ABSCESS. DURING THE REOPERATION, THE SURGEON STATED YOU COULD SEE WHERE STITCHES HAD BEEN AND THE TISSUE SEEMED ROTTED. THE PATIENT UNDERWENT I&D, DEBRIDEMENT WITH WOUND VAC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abscess; Not Applicable; Pain; Swelling

  MAUDE report 7806944 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022269. One submission often covers many models, so check the product and lot details in each record.

• Z-2144-2024 · May 10, 2024 · Open, Classified
  VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and
• Z-0989-2020 · Jan 3, 2020 · Terminated
  Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
• Z-1087-06 · May 4, 2006 · Terminated
  Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gyc