PDS PDPB740DRecalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10705031218840), received between Oct 23, 2018 and Aug 13, 2026 — classified as 8 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Material Separation” (23 reports).

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 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50236049 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT SURGERY FOR PERIHILAR CHOLANGIOCARCINOMA ON AN UNKNOWN DATE AND SUTURE WAS USED FOR ABNORMAL WALL CLOSURE. AFTER THAT, ALTHOUGH DETAILS ARE UNCLEAR, AN SSI OCCURRED. INFORMATION ABOUT TREATMENT AFTER THIS ISSUE AND THE PATIENT¿S CONDITION IS UNKNOWN. THE DOCTOR COMMENTED THAT SSIS ARE NOT VERY COMMON. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 24215399 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT SURGERY FOR PERIHILAR CHOLANGIOCARCINOMA ON AN UNKNOWN DATE AND SUTURE WAS USED FOR ABNORMAL WALL CLOSURE. AFTER THAT, ALTHOUGH DETAILS ARE UNCLEAR, AN SSI OCCURRED. INFORMATION ABOUT TREATMENT AFTER THIS ISSUE AND THE PATIENT¿S CONDITION IS UNKNOWN. THE DOCTOR COMMENTED THAT SSIS ARE NOT VERY COMMON. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 24215398 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT SURGERY FOR PERIHILAR CHOLANGIOCARCINOMA ON AN UNKNOWN DATE AND SUTURE WAS USED FOR ABNORMAL WALL CLOSURE. AFTER THAT, ALTHOUGH DETAILS ARE UNCLEAR, RE-LAPAROTOMY WAS REQUIRED DURING THE PERIOPERATIVE PERIOD. INFORMATION ABOUT TREATMENT AFTER THIS ISSUE AND THE PATIENT¿S CONDITION IS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24215393 ↗
• MalfunctionSep 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN 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 HAD BEEN DETACHED FROM THE SUTURE DURING USE. IT WAS A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. 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 22977405 ↗
• MalfunctionAug 27, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, AN ISSUE HAD OCCURRED. IT WAS NOT KNOWN WHETHER THE NEEDLE WAS BROKEN OR WHETHER THE NEEDLE WAS NOT POLISHED FROM THE BEGINNING. THE OPERATION TIME WAS EXTENDED WHEN THIS EVENT OCCURRED BECAUSE CT SCANS AND X-RAYS WERE TAKEN. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22903515 ↗
• MalfunctionJun 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY THAN USUAL DURING USE. (THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY WHEN PULLING THE SUTURE SLIGHTLY.) IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. 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 22153691 ↗
• InjuryMay 23, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROTOMY AND MIDLINE INCISION ON AN UNKNOWN DATE AND SUTURE WAS USED WITH PLACING 2 STITCHES AT EACH END OF THE WOUND. ONE WEEK AFTER THE SURGERY, THE PATIENT HAD A WOUND DEHISCENCE. THE PATIENT UNDERWENT REOPERATION BECAUSE THE INTESTINES CAME OUT. THE SUTURE HAD BROKEN WHEN THE WOUND DEHISCENCE OCCURRED. THE ABDOMINAL WALL WAS NOT CUT. ALL THE MIDPOINTS BETWEEN THE CONTINUOUSLY SUTURED TISSUES AND TISSUES WERE CUT. THE NODES WERE ALSO CUT. THERE WAS A SURGICAL SITE INFECTION. THE PATIENT IS STABLE. NO SAMPLE WILL BE RETURNED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 22078003 ↗
• MalfunctionJan 30, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED FOR WOUND CLOSURE. THE NEEDLE TIP WAS BROKEN DURING FASCIA SUTURING. THE BROKEN NEEDLE TIP WAS RETRIEVED. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21280305 ↗
• MalfunctionJan 2, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, TWO SUTURES WERE DETACHED FROM THE NEEDLE EASILY. IT WAS 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 21060824 ↗
• MalfunctionJan 2, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, TWO SUTURES WERE DETACHED FROM THE NEEDLE EASILY. IT WAS 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 21060823 ↗
• MalfunctionDec 12, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS FOUND THERE WAS LIKE AN OIL ON THE NEEDLE. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20915908 ↗
• MalfunctionAug 26, 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, IT WAS REPORTED BY A SALES REP THAT DURING WOUND CLOSURE FOR ABDOMINAL FASCIA, THE NEEDLE HAD BEEN DETACHED IN THE MIDDLE OF THE HANDLING OF A NEEDLE. THE CAULKING MUST BE WEAK. IT WAS A CONTROL RELEASE NEEDLE. LOT NUMBER - TMMJQR OR UBMCZS - UNKNOWN IF THIS IS THE CORRECT LOT NUMBER. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20066474 ↗
• MalfunctionApr 18, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19134930 ↗
• MalfunctionOct 11, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY DURING INTERRUPTED SUTURING. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17911971 ↗
• MalfunctionJun 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC ANEURYSM GRAFT REPLACEMENT PROCEDURE ON (B)(6) 2023AND SUTURE WAS USED. WHEN THE PRODUCT WAS USED ON FASCIA WITH INTERRUPTED SUTURING DURING WOUND CLOSURE, THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17039144 ↗
• MalfunctionJun 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC ANEURYSM GRAFT REPLACEMENT PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. WHEN THE PRODUCT WAS USED ON FASCIA WITH INTERRUPTED SUTURING DURING WOUND CLOSURE, THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17039142 ↗
• MalfunctionMay 8, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC ANEURYSM GRAFT REPLACEMENT PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. WHEN THE PRODUCT WAS USED ON FASCIA WITH INTERRUPTED SUTURING DURING WOUND CLOSURE, THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16891605 ↗
• MalfunctionFeb 3, 2023Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16299004 ↗
• MalfunctionNov 7, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE DETACHED FROM THE NEEDLE. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15749324 ↗
• MalfunctionMay 17, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN THE LEVATOR ANI MUSCLE WAS SUTURED WITH THE PRODUCT, THE SUTURE BROKE AND THEN THE TISSUE RUPTURED, LEADING THE PATIENT GETTING A HERNIA. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hernia; Unspecified Tissue Injury

  MAUDE report 14415249 ↗
• InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PLASTIC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. ABOUT A MONTH AFTER THE PROCEDURE, PIGMENTATION OCCURRED IN THE PATIENT WHO UNDERWENT RELAXATION SUTURING AT A SITE SHALLOWER THAN THE SUPERFICIAL FASCIA AND INTERRUPTED SUTURING WAS PERFORMED. THE SURGERY WAS PERFORMED ABOUT 2 YEARS AGO. BECAUSE PIGMENTATION IS A CONCERN, SCAR EXCISION IS SCHEDULED TO BE PERFORMED SOON. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Skin Discoloration

  MAUDE report 14310350 ↗
• MalfunctionMar 15, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE NEEDLE HAD BEEN BROKEN BEFORE IT WAS TAKEN OUT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13765438 ↗
• MalfunctionFeb 15, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN PASSING THE NEEDLE THROUGH THE TISSUE DURING INTERRUPTED SUTURING, SUTURE BREAKAGE OCCURRED IN A ROW. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13539508 ↗
• MalfunctionJan 7, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL FUSION PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, ALTHOUGH NO EXTRA FORCE WAS APPLIED, THREE SUTURES DETACHED FROM THE NEEDLES IN A ROW DURING INTERRUPTED SUTURING ON THE MUSCLE LAYER. THEY WERE CONTROL RELEASE NEEDLES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13187728 ↗