PDS Z494GRecalls & reported problems

Summary

The FDA's MAUDE database contains 159 adverse event reports that list this exact device (DI 10705031061170), received between Dec 12, 2017 and Mar 30, 2026 — classified as 5 injuries, 154 malfunctions.

The most frequently reported specific device problem is “Break” (134 reports).

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

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.

Recalls naming this device

1. Aug 10, 2023Open, Classified

   Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.

   Z-2617-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 159 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE WHILE THE SURGEON WAS SUTURING, AND THE NEEDLE PIECE WAS LEFT IN THE PATIENT'S BODY DUE TO THE AREA WHERE IT BROKE. THE NEEDLE PIECE WAS LEFT IN THE SEPTUM /SURROUNDING SOFT TISSUE. AT THIS TIME, THERE IS NO PLAN IN PLACE TO REMOVE THE NEEDLE PIECE. THE PATIENT WAS PLACED ON ANTIBIOTICS POST OPERATIVELY, AND THE SURGEON WILL CONTINUE TO MONITOR PATIENT TO ENSURE THE FOREIGN BODY DOES NOT CAUSE POSSIBLY INFECTION, AND IF IT STARTS TO PROTRUDE OUT TO TRY, THE SURGEON MAY POSSIBLY REMOVE AT THAT TIME. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24711925 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN ABDOMEN/CHEST SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE WAS BROKEN WHEN THE NEEDLE PASSED THROUGH THE DERMIS AND REMOVED THE NEEDLE DURING SUTURING THE DERMIS TO CLOSE THE WOUND. THE PIECE FELL INTO THE SURGICAL FIELD. THE PRODUCT WAS USED ON THE DERMIS. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WAS NO PROBLEM TO THE PATIENT. NO PIECES WERE LEFT INSIDE THE PATIENT BECAUSE THE BROKEN NEEDLE HAS ALSO BEEN RETRIEVED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23021503 ↗
• MalfunctionJul 1, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN RESPIRATORY SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE NEEDLE WAS BROKEN WHEN THE NEEDLE WAS HOLDING EVEN THOUGH NO APPLYING FORCE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22374085 ↗
• MalfunctionJan 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWEN AN UNKNOWN SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21287225 ↗
• MalfunctionJan 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWEN AN UNKNOWN SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21287224 ↗
• MalfunctionJan 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MAMMECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED FOR WOUND CLOSURE. DURING THE PROCEDURE, SUTURE BREAKAGE OCCURRED FREQUENTLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21196359 ↗
• MalfunctionJan 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MAMMECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED FOR WOUND CLOSURE. DURING THE PROCEDURE, SUTURE BREAKAGE OCCURRED FREQUENTLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21196356 ↗
• MalfunctionJan 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE SUTURE WAS BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21184009 ↗
• MalfunctionJan 10, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENT PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT DURING AN ENT PROCEDURE THAT WHILE SUTURING THE "SUTURE KEPT FALLING OFF INTO THE WOUND". ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21129885 ↗
• MalfunctionJan 10, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENT PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT DURING AN ENT PROCEDURE THAT WHILE SUTURING THE "SUTURE KEPT FALLING OFF INTO THE WOUND". ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21129884 ↗
• MalfunctionJan 8, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE BROKE DURING THE OPERATION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21101091 ↗
• MalfunctionJan 8, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE BROKE DURING THE OPERATION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21101090 ↗
• MalfunctionJan 8, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE BROKE DURING THE OPERATION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21101087 ↗
• MalfunctionJan 8, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE BROKE DURING THE OPERATION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21101086 ↗
• MalfunctionJan 8, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE BROKE DURING THE OPERATION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21101084 ↗
• MalfunctionJan 8, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE BROKE DURING THE OPERATION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21101083 ↗
• MalfunctionJan 8, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE BROKE DURING THE OPERATION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21101082 ↗
• MalfunctionJan 8, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE BROKE DURING THE OPERATION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21101081 ↗
• MalfunctionJan 8, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE BROKE DURING THE OPERATION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21101080 ↗
• MalfunctionJan 8, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE BROKE DURING THE OPERATION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21101079 ↗
• MalfunctionJan 8, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE BROKE DURING THE OPERATION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21101078 ↗
• MalfunctionDec 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENT PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT DURING AN ENT PROCEDURE THAT WHILE SUTURING THE "SUTURE KEPT FALLING OFF INTO THE WOUND". ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21036897 ↗
• MalfunctionDec 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENT PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT DURING AN ENT PROCEDURE THAT WHILE SUTURING THE "SUTURE KEPT FALLING OFF INTO THE WOUND". ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21036884 ↗
• MalfunctionNov 8, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE DEVICE WAS USED. DURING SURGERY THEY TRIED TO USE THE SUTURE, BUT THE SUTURE WAS BROKEN. THERE WAS NO PROBLEM TO THE PATIENT. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20642668 ↗
• MalfunctionAug 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE AND THE SUTURE HAD BEEN DETACHED. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19951481 ↗