PDS PDP340HRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10705031048102), received between Jul 31, 2019 and Dec 31, 2025 — classified as 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (19 reports).

9 other recalls cover devices cleared under the same FDA submission (K061037, K212380, K243897); 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PDS PLUS 0 NEEDLE CT-1 ROUND 1/2 X 36 MM (70 CM) SUTURE BROKE TWICE WHEN THE APONEUROSIS WAS BEING SUTURED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23935317 ↗
• MalfunctionDec 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PDS PLUS 0 NEEDLE CT-1 ROUND 1/2 X 36 MM (70 CM) SUTURE BROKE TWICE WHEN THE APONEUROSIS WAS BEING SUTURED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23935307 ↗
• MalfunctionMar 12, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A ROBOTIC ASSISTED LAPAROSCOPIC EXPLORATORY SURGERY WITH BILATERAL SALPINGO-OOPHORECTOMY ON (B)(6) 2025 AND SUTURE WAS USED. NEEDLE BROKE ON SUTURES CODES DURING THE PROCEDURE. NEEDLE WAS RECOVERED. NO X-RAY NEEDED TO RECOVER THE NEEDLE. ANOTHER LIKE DEVICE OF SUTURE CODE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21584336 ↗
• MalfunctionApr 19, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE LOOSENED OFF THE SUTURE WITHOUT EVEN PULLING IT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19146118 ↗
• MalfunctionMar 14, 2024Break; Break

  IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTHROPLASTY PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER TWO TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18906402 ↗
• MalfunctionMar 14, 2024Break; Break

  IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTHROPLASTY PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER TWO TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18906397 ↗
• MalfunctionMar 14, 2024Break; Break

  IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTHROPLASTY PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER TWO TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18906396 ↗
• MalfunctionMar 13, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTHROPLASTY PROCEDURE ON (B)(6) 2024JJ; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18897189 ↗
• MalfunctionMar 13, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTHROPLASTY PROCEDURE ON (B)(6) 2024 AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18897183 ↗
• MalfunctionFeb 23, 2024Material Separation; Material Separation

  IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE NEEDLE WAS DETACHED FROM THE SUTURE DURING USE. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. 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. AFFILIATE REFERENCE NUMBER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18767433 ↗
• MalfunctionJan 29, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MINI LAPAROTOMY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE STRAND BROKE. THE SURGEON COMPLETED THE CASE USING ANOTHER SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18594370 ↗
• MalfunctionJan 29, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MINI LAPAROTOMY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE STRAND BROKE. THE SURGEON COMPLETED THE CASE USING ANOTHER SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18594369 ↗
• MalfunctionJan 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE, ALTHOUGH IT WAS NOT PULLED HARD DURING USE IN THE ABDOMINAL CAVITY. 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 18458594 ↗
• MalfunctionJul 26, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IN SURGERY CLOSURE THE SUTURE NEEDLE TIP FRACTURED ABOUT 1 MM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398316 ↗
• InjuryMar 16, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION ON (B)(6) 2023 AND SUTURE WAS USED ON THE FASCIA OF THE ABDOMINAL WALL. POST-OP, ON (B)(6) 2023, THE WOUND OF THE ABDOMEN WAS DEHISCENT AND THE INTESTINE PROTRUDED, THEREFORE RE-OPERATION WAS PERFORMED. DURING THE RE-OPERATION, IT WAS FOUND THAT THE SUTURE HAD BEEN RUPTURED, AND INTERRUPTED SUTURE WAS PERFORMED. THE SURGEON COMMENTED THAT THERE WERE NO FINDINGS SUGGESTIVE OF INFECTION. THE LIGATURE POINTS AT BOTH ENDS WERE NOT UNTIED, AND THERE IS A POSSIBILITY OF RUPTURE OF THE SUTURE. THE SURGEON DID NOT GRASP THE SUTURE WITH FORCEPS DURING THE SURGERY. ON (B)(6) 2023, THE PATIENT WAS DOING WELL. CURRENT STATUS OF THE PATIENT WAS REPORTED AS IN THE HOSPITAL. THE SURGEON OPINED THAT BECAUSE THE SUTURE COLLECTED FROM THE WOUND DEHISCENCE WAS RUPTURED, THERE MAY BE SOME RELATIONSHIP BETWEEN THE PRODUCT AND THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 16558495 ↗
• InjuryMar 16, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION ON (B)(6) 2023 AND SUTURE WAS USED ON THE FASCIA OF THE ABDOMINAL WALL. POST-OP, ON (B)(6) 2023, THE WOUND OF THE ABDOMEN WAS DEHISCENT AND THE INTESTINE PROTRUDED, THEREFORE RE-OPERATION WAS PERFORMED. DURING THE RE-OPERATION, IT WAS FOUND THAT THE SUTURE HAD BEEN RUPTURED, AND INTERRUPTED SUTURE WAS PERFORMED. THE RE-OPERATION TOOK 50 MINUTES. ON (B)(6) 2023, THE PATIENT WAS DOING WELL. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS IN THE HOSPITAL AND DOING WELL. THE SURGEON COMMENTED THAT BECAUSE THE SUTURE COLLECTED FROM THE WOUND DEHISCENCE WAS RUPTURED, THERE IS SOME RELATIONSHIP BETWEEN THE PRODUCT AND THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 16556490 ↗
• InjuryJan 24, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION ON (B)(6) 2023 AND SUTURE WAS USED. POST-OP, THE SUTURE WAS BROKEN AND DEHISCENCE OCCURRED. WHEN OBSERVED POSTOPERATIVELY ON POSTOPERATIVE DAY 2, THE SURFACE LAYER WAS OPEN. THE SURGEON COULD SEE THAT THE SUTURE WAS BROKEN AS IF IT WAS COMING OUT OF THE WOUND. THE INITIALLY THOUGHT IT WAS A SUPERFICIAL LAYER, BUT IT WAS THE INTESTINE. THERE WERE NO SIGNS OF INFECTION. ON (B)(6) 2023, DEHISCENCE WAS CONFIRMED, AND REOPERATION WAS PERFORMED. THERE WAS NO PROBLEM IN THE ABDOMINAL CAVITY. A LONGITUDINAL INCISION WAS MADE. THE LIGATED PART OF THE STARTING POINT OF THE FASCIAL SUTURE REMAINED, BUT THE SURGEON THOUGHT IT MIGHT HAVE BROKEN AND BECOME UNTIED. THE WOUND WAS CLOSED WITH MATTRESS WITH SAME SUTURE. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS IN THE HOSPITAL. IT WAS OPINED THAT IF SIGNS OF INFECTION DEVELOP, THERE WOULD BE CONCERN ABOUT FUTURE INCISIONAL HERNIAS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 16235419 ↗
• MalfunctionJun 2, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BREAKING. EXCHANGED FOR A DIFFERENT LOT NUMBER WITH NO FURTHER ISSUES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11919090 ↗
• MalfunctionJun 2, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BREAKING. EXCHANGED FOR A DIFFERENT LOT NUMBER WITH NO FURTHER ISSUES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11919088 ↗
• MalfunctionJun 2, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BREAKING. EXCHANGED FOR A DIFFERENT LOT NUMBER WITH NO FURTHER ISSUES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11919086 ↗
• MalfunctionApr 10, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC OB-GYN PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF FROM THE NEEDLE WHILE PASSING THROUGH THE TISSUE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9947911 ↗
• MalfunctionJul 31, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TENDON OF ACHILLES REPAIR SURGERY IN 2019 AND THE SUTURE WAS USED. DURING THE SUTURING, THE SUTURE FRACTIONATED WITHOUT MAKING A RELEVANT FORCE AND IT BROKE. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8849206 ↗
• MalfunctionJul 31, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TENDON OF ACHILLES SURGERY IN 2019 AND THE SUTURE WAS USED. DURING THE SUTURING, THE SUTURE FRACTIONATED WITHOUT MAKING A RELEVANT FORCE AND IT BROKE. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8849204 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061037, K212380, K243897. One submission often covers many models, so check the product and lot details in each record.

• Z-2147-2024 · May 10, 2024 · Open, Classified
  PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in oph
• Z-1571-2023 · Mar 31, 2023 · Open, Classified
  PDS Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatri
• Z-1135-2019 · Mar 12, 2019 · Terminated
  VICRYL PLUS Sutures: VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO VICRYL PLUS SUTURE 18"(45CM) 0 UND VICRYL PLUS SUTURE 18"(45CM) 0 VIO VICRYL PLUS SUTURE 18"(45CM) 0 VIO) VICRYL PLUS SU
• Z-2533-2018 · Jun 8, 2018 · Terminated
  PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G (GTIN 10705031203945)
• Z-2532-2018 · Jun 8, 2018 · Terminated
  PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18") 4-0 Single Armed PS-4 Prime Needle Product Code: PDP507G (GTIN 10705031203983)
• Z-1338-2018 · Jan 10, 2018 · Terminated
  PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle
• Z-1340-2018 · Jan 10, 2018 · Terminated
  PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle
• Z-1339-2018 · Jan 10, 2018 · Terminated
  PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 Needle
• Z-1314-2009 · Feb 2, 2009 · Terminated
  PDS Plus Antibacterial (polydioxanone) Suture Sutures are intended for general soft tissue approximation and/or ligation.