PDS Z340HRecalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 10705031060623), received between Jun 5, 2018 and Mar 26, 2026 — classified as 5 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Break” (40 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. Nov 16, 2022Open, Classified

   knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than premature post-operative breakage

   Z-0480-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Material Separation; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY SALES REP THAT ACCOUNT HAD MULTIPLE INCIDENTS WHERE THE NEEDLES WERE FALLING OFF OF THE MONOCRYL 2-0 AND 4-0 AND PDS THEY ORDERING. THIS HAPPENED WITH VARIOUS LOT NUMBER OVER A PERIOD OF ABOUT A YEAR. THEY WERE UNABLE TO RECORD THE LOT NUMBERS OF THE AFFECTED PRODUCTS AT THE TIME. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE AVAILABILITY IS UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24705953 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN VAGINAL CUFF REPAIR ON AN UNKNOWN DATE AND SUTURE WAS USED. NO CHANGES WERE MADE TO THE SURGICAL TECHNIQUE. POST-OP, THE PATIENT EXPERIENCED A DEHISCENCE, REQUIRING THE PATIENT TO RETURN TO THE OPERATING ROOM. THE DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 24144199 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN VAGINAL CUFF REPAIR ON AN UNKNOWN DATE AND SUTURE WAS USED. NO CHANGES WERE MADE TO THE SURGICAL TECHNIQUE. POST-OP, THE PATIENT EXPERIENCED A DEHISCENCE, REQUIRING THE PATIENT TO RETURN TO THE OPERATING ROOM. THE DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 24144192 ↗
• MalfunctionMay 20, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SIGMOIDECTOMY IN 2025 AND SUTURE WAS USED. WHEN SUTURING FASCIA CLOSED FROM A HAND PORT, THE NEEDLE BROKE INTO TWO PIECES NEAR THE SWAGE. FOUND THE BROKEN NEEDLE AND REMOVED. OPENED NEW SUTURE TO COMPLETE THE PROCEDURE. PROCEDURE WAS COMPLETED WITH A DELAY OF 5 MINUTES. NO PATIENT HARM WAS REPORTED. DEVICE WAS NOT RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22057088 ↗
• MalfunctionApr 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ANIMAL PROCEDURE ON (B)(6) AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT THEY HAVE A BOX OF SUTURE THAT THE SURGEON REPORTS 3 CONSECUTIVE PACKS THAT THE NEEDLE CAME OFF THE SUTURE VERY EASILY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21899475 ↗
• MalfunctionApr 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ANIMAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT THEY HAVE A BOX OF SUTURE THAT THE SURGEON REPORTS 3 CONSECUTIVE PACKS THAT THE NEEDLE CAME OFF THE SUTURE VERY EASILY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21899472 ↗
• MalfunctionApr 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ANIMAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT THEY HAVE A BOX OF SUTURE THAT THE SURGEON REPORTS 3 CONSECUTIVE PACKS THAT THE NEEDLE CAME OFF THE SUTURE VERY EASILY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21899470 ↗
• MalfunctionApr 21, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SURGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE THREAD BROKE DURING SURGERY AND IT HAD NOT BEEN SUBJECTED TO ANY EXCEPTIONALLY HIGH LOAD. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21871998 ↗
• MalfunctionApr 21, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SURGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE THREAD BROKE AFTER SURGERY AND IT HAD NOT BEEN SUBJECTED TO ANY EXCEPTIONALLY HIGH LOAD. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21871995 ↗
• MalfunctionDec 12, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ANIMAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT NEGATIVE EXPLORE, LINEA CLOSED WITH 0 PDS IN INTERRUPTED CRUCIATE AND SIMPLE PATTERN. DEHISCED 9 DAYS POST-OP. REVISITATION REQUIRED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 20915236 ↗
• MalfunctionSep 23, 2024Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL SURGERY WAS PERFORMED ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE DISCONNECT FROM THE SUTURE ALMOST IMMEDIATELY. THERE WAS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20280997 ↗
• MalfunctionSep 23, 2024Material Separation; Material Separation

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THEY OPENED A BOX OF 0 PDS AND FOUR SUTURES FROM THIS BOX HAD THE SUTURE DISCONNECT FROM THE SUTURE ALMOST IMMEDIATELY. THEY HAVE NEVER HAD THIS PROBLEM BEFORE. THERE WAS NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20280994 ↗
• MalfunctionSep 23, 2024Material Separation; Material Separation

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THEY OPENED A BOX OF 0 PDS AND FOUR SUTURES FROM THIS BOX HAD THE SUTURE DISCONNECT FROM THE SUTURE ALMOST IMMEDIATELY. THEY HAVE NEVER HAD THIS PROBLEM BEFORE. THERE WAS NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20280993 ↗
• MalfunctionSep 23, 2024Material Separation; Material Separation

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THEY OPENED A BOX OF 0 PDS AND FOUR SUTURES FROM THIS BOX HAD THE SUTURE DISCONNECT FROM THE SUTURE ALMOST IMMEDIATELY. THEY HAVE NEVER HAD THIS PROBLEM BEFORE. THERE WAS NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20280991 ↗
• InjuryJun 17, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SCHEDULED REPEAT C SECTION ON (B)(6) 2024 AND SUTURE WAS USED TO CLOSE THE FASCIA. IT WAS NOTED TO CLOSE AT THE KNOT TYING, IT WAS ABLE TO BE CLOSED AS USUAL. POST-OP, THE PATIENT HAD PERSISTENT BLEEDING FROM THE INCISION. THE PATIENT WAS RETURNED TO THE OR. ON OPENING THE ABDOMEN THE SUTURE WAS NOTED TO BE SNAPPED IN THE CENTER. THE PATIENT IS RECOVERING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19546103 ↗
• MalfunctionJun 4, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HYSTERECTOMY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. WHEN SUTURING AT THE HYSTERECTOMY STUMP, 3 SUTURES WERE BROKEN IN A ROW. THE OPERATION TIME WAS NO EXTENSION. 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 19457355 ↗
• MalfunctionJun 4, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HYSTERECTOMY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. WHEN SUTURING AT THE HYSTERECTOMY STUMP, 3 SUTURES WERE BROKEN IN A ROW. THE OPERATION TIME WAS NO EXTENSION. 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 19457273 ↗
• MalfunctionJun 4, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HYSTERECTOMY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. WHEN SUTURING AT THE HYSTERECTOMY STUMP, 3 SUTURES WERE BROKEN IN A ROW. THE OPERATION TIME WAS NO EXTENSION. 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 19457264 ↗
• MalfunctionMar 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN ABDOMINAL SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. WHEN THE DOCTOR WAS CLOSING THE ABDOMINAL PLANES, THE SUTURE WAS REQUESTED. WHEN THE INSTRUMENTATOR SET THE SUTURE, IT WAS EVIDENT THAT THE STRAND WAS LOOSE FROM THE NEEDLE. THEREFORE IT WAS CHANGED. THERE WAS NO SURGICAL DELAY OR PATIENT CONSEQUENCE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18979686 ↗
• MalfunctionMar 12, 2024Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. SUTURE IS BREAKING UNDER REGULAR TENSION.¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18890581 ↗
• MalfunctionMar 12, 2024Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. SUTURE IS BREAKING UNDER REGULAR TENSION.¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18890563 ↗
• MalfunctionMar 12, 2024Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. SUTURE IS BREAKING UNDER REGULAR TENSION.¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18890555 ↗
• MalfunctionJan 16, 2024Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT A SPLENECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DISTRIBUTOR BY THE CUSTOMER THAT THE SUTURE IS BREAKING UNDER REGULAR TENSION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18522378 ↗
• MalfunctionJan 12, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON FELT THE SUTURE WAS NOT PERFORMING AS IT SHOULD. THE SUTURE WAS ¿SNAPPING¿, BREAKING MORE EASILY THAN IT SHOULD.. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18502901 ↗
• MalfunctionApr 4, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE (B)(6) 2023 AND SUTURE WAS USED. THE NEEDLE DETACHED/FELL OFF THREAD DURING SURGERY. THERE WERE NO ADVERSE CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16672827 ↗