PROLENE 8523HRecalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 10705031016590), received between Dec 27, 2017 and May 28, 2026 — classified as 12 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Break” (47 reports).

21 other recalls cover devices cleared under the same FDA submission (K133356); 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 25 most recent of 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY SISTER THAT A SUTURES BIFURCATED DURING CABG PROCEDURE. THE ISSUE WAS IDENTIFIED DURING INTRAOPERATIVE USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25322583 ↗
• MalfunctionFeb 23, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THIS PRODUCT WAS REJECTED AT INCOMING INSPECTION DUE TO A FOREIGN FIBER MATTER THAT WAS IN THE PACKAGE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24418021 ↗
• MalfunctionFeb 23, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THIS PRODUCT WAS REJECTED AT INCOMING INSPECTION DUE TO A FOREIGN FIBER MATTER THAT WAS IN THE PACKAGE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24418013 ↗
• MalfunctionNov 26, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE SURGICAL LIGATION OF THE FEMORAL GROOVE HERNIA, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED AND A NEW SUTURE WAS IMMEDIATELY REPLACED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658178 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC GASTROSTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A LAPAROSCOPIC GASTROSTOMY FOR DYSPHAGIA, THE PRODUCT WAS USED ON THE GASTRIC MUCOSA FOR SUTURING. DURING THE SUTURING PROCEDURE, WHEN THE NEEDLE WAS PASSED THROUGH THE TISSUE AND PULLED, THE SUTURE WAS BROKEN A FEW TIMES AT A POINT A LITTLE AWAY FROM THE SWAGE PART. THEREFORE, THE SUTURE WAS REPLACED WITH A NEW ONE AND THE SUTURING WAS PERFORMED AGAIN. IT WAS NOT A CONTROL RELEASE NEEDLE. 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 23534110 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC GASTROSTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A LAPAROSCOPIC GASTROSTOMY FOR DYSPHAGIA, THE PRODUCT WAS USED ON THE GASTRIC MUCOSA FOR SUTURING. DURING THE SUTURING PROCEDURE, WHEN THE NEEDLE WAS PASSED THROUGH THE TISSUE AND PULLED, THE SUTURE WAS BROKEN A FEW TIMES AT A POINT A LITTLE AWAY FROM THE SWAGE PART. THEREFORE, THE SUTURE WAS REPLACED WITH A NEW ONE AND THE SUTURING WAS PERFORMED AGAIN. IT WAS NOT A CONTROL RELEASE NEEDLE. 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 23534104 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC GASTROSTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A LAPAROSCOPIC GASTROSTOMY FOR DYSPHAGIA, THE PRODUCT WAS USED ON THE GASTRIC MUCOSA FOR SUTURING. DURING THE SUTURING PROCEDURE, WHEN THE NEEDLE WAS PASSED THROUGH THE TISSUE AND PULLED, THE SUTURE WAS BROKEN A FEW TIMES AT A POINT A LITTLE AWAY FROM THE SWAGE PART. THEREFORE, THE SUTURE WAS REPLACED WITH A NEW ONE AND THE SUTURING WAS PERFORMED AGAIN. IT WAS NOT A CONTROL RELEASE NEEDLE. 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 23534094 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC GASTROSTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A LAPAROSCOPIC GASTROSTOMY FOR DYSPHAGIA, THE PRODUCT WAS USED ON THE GASTRIC MUCOSA FOR SUTURING. DURING THE SUTURING PROCEDURE, WHEN THE NEEDLE WAS PASSED THROUGH THE TISSUE AND PULLED, THE SUTURE WAS BROKEN A FEW TIMES AT A POINT A LITTLE AWAY FROM THE SWAGE PART. THEREFORE, THE SUTURE WAS REPLACED WITH A NEW ONE AND THE SUTURING WAS PERFORMED AGAIN. IT WAS NOT A CONTROL RELEASE NEEDLE. 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 23534090 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC GASTROSTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A LAPAROSCOPIC GASTROSTOMY FOR DYSPHAGIA, THE PRODUCT WAS USED ON THE GASTRIC MUCOSA FOR SUTURING. DURING THE SUTURING PROCEDURE, WHEN THE NEEDLE WAS PASSED THROUGH THE TISSUE AND PULLED, THE SUTURE WAS BROKEN A FEW TIMES AT A POINT A LITTLE AWAY FROM THE SWAGE PART. THEREFORE, THE SUTURE WAS REPLACED WITH A NEW ONE AND THE SUTURING WAS PERFORMED AGAIN. IT WAS NOT A CONTROL RELEASE NEEDLE. 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 23534089 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC GASTROSTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A LAPAROSCOPIC GASTROSTOMY FOR DYSPHAGIA, THE PRODUCT WAS USED ON THE GASTRIC MUCOSA FOR SUTURING. DURING THE SUTURING PROCEDURE, WHEN THE NEEDLE WAS PASSED THROUGH THE TISSUE AND PULLED, THE SUTURE WAS BROKEN A FEW TIMES AT A POINT A LITTLE AWAY FROM THE SWAGE PART. THEREFORE, THE SUTURE WAS REPLACED WITH A NEW ONE AND THE SUTURING WAS PERFORMED AGAIN. IT WAS NOT A CONTROL RELEASE NEEDLE. 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 23534085 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC GASTROSTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A LAPAROSCOPIC GASTROSTOMY FOR DYSPHAGIA, THE PRODUCT WAS USED ON THE GASTRIC MUCOSA FOR SUTURING. DURING THE SUTURING PROCEDURE, WHEN THE NEEDLE WAS PASSED THROUGH THE TISSUE AND PULLED, THE SUTURE WAS BROKEN A FEW TIMES AT A POINT A LITTLE AWAY FROM THE SWAGE PART. THEREFORE, THE SUTURE WAS REPLACED WITH A NEW ONE AND THE SUTURING WAS PERFORMED AGAIN. IT WAS NOT A CONTROL RELEASE NEEDLE. 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 23534067 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC GASTROSTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A LAPAROSCOPIC GASTROSTOMY FOR DYSPHAGIA, THE PRODUCT WAS USED ON THE GASTRIC MUCOSA FOR SUTURING. DURING THE SUTURING PROCEDURE, WHEN THE NEEDLE WAS PASSED THROUGH THE TISSUE AND PULLED, THE SUTURE WAS BROKEN A FEW TIMES AT A POINT A LITTLE AWAY FROM THE SWAGE PART. THEREFORE, THE SUTURE WAS REPLACED WITH A NEW ONE AND THE SUTURING WAS PERFORMED AGAIN. IT WAS NOT A CONTROL RELEASE NEEDLE. 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 23534063 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC GASTROSTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A LAPAROSCOPIC GASTROSTOMY FOR DYSPHAGIA, THE PRODUCT WAS USED ON THE GASTRIC MUCOSA FOR SUTURING. DURING THE SUTURING PROCEDURE, WHEN THE NEEDLE WAS PASSED THROUGH THE TISSUE AND PULLED, THE SUTURE WAS BROKEN A FEW TIMES AT A POINT A LITTLE AWAY FROM THE SWAGE PART. THEREFORE, THE SUTURE WAS REPLACED WITH A NEW ONE AND THE SUTURING WAS PERFORMED AGAIN. IT WAS NOT A CONTROL RELEASE NEEDLE. 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 23534058 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC GASTROSTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A LAPAROSCOPIC GASTROSTOMY FOR DYSPHAGIA, THE PRODUCT WAS USED ON THE GASTRIC MUCOSA FOR SUTURING. DURING THE SUTURING PROCEDURE, WHEN THE NEEDLE WAS PASSED THROUGH THE TISSUE AND PULLED, THE SUTURE WAS BROKEN A FEW TIMES AT A POINT A LITTLE AWAY FROM THE SWAGE PART. THEREFORE, THE SUTURE WAS REPLACED WITH A NEW ONE AND THE SUTURING WAS PERFORMED AGAIN. IT WAS NOT A CONTROL RELEASE NEEDLE. 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 23534057 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC GASTROSTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A LAPAROSCOPIC GASTROSTOMY FOR DYSPHAGIA, THE PRODUCT WAS USED ON THE GASTRIC MUCOSA FOR SUTURING. DURING THE SUTURING PROCEDURE, WHEN THE NEEDLE WAS PASSED THROUGH THE TISSUE AND PULLED, THE SUTURE WAS BROKEN A FEW TIMES AT A POINT A LITTLE AWAY FROM THE SWAGE PART. THEREFORE, THE SUTURE WAS REPLACED WITH A NEW ONE AND THE SUTURING WAS PERFORMED AGAIN. IT WAS NOT A CONTROL RELEASE NEEDLE. 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 23534038 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC GASTROSTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A LAPAROSCOPIC GASTROSTOMY FOR DYSPHAGIA, THE PRODUCT WAS USED ON THE GASTRIC MUCOSA FOR SUTURING. DURING THE SUTURING PROCEDURE, WHEN THE NEEDLE WAS PASSED THROUGH THE TISSUE AND PULLED, THE SUTURE WAS BROKEN A FEW TIMES AT A POINT A LITTLE AWAY FROM THE SWAGE PART. THEREFORE, THE SUTURE WAS REPLACED WITH A NEW ONE AND THE SUTURING WAS PERFORMED AGAIN. IT WAS NOT A CONTROL RELEASE NEEDLE. 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 23534034 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC GASTROSTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A LAPAROSCOPIC GASTROSTOMY FOR DYSPHAGIA, THE PRODUCT WAS USED ON THE GASTRIC MUCOSA FOR SUTURING. DURING THE SUTURING PROCEDURE, WHEN THE NEEDLE WAS PASSED THROUGH THE TISSUE AND PULLED, THE SUTURE WAS BROKEN A FEW TIMES AT A POINT A LITTLE AWAY FROM THE SWAGE PART. THEREFORE, THE SUTURE WAS REPLACED WITH A NEW ONE AND THE SUTURING WAS PERFORMED AGAIN. IT WAS NOT A CONTROL RELEASE NEEDLE. 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 23534021 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC GASTROSTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A LAPAROSCOPIC GASTROSTOMY FOR DYSPHAGIA, THE PRODUCT WAS USED ON THE GASTRIC MUCOSA FOR SUTURING. DURING THE SUTURING PROCEDURE, WHEN THE NEEDLE WAS PASSED THROUGH THE TISSUE AND PULLED, THE SUTURE WAS BROKEN A FEW TIMES AT A POINT A LITTLE AWAY FROM THE SWAGE PART. THEREFORE, THE SUTURE WAS REPLACED WITH A NEW ONE AND THE SUTURING WAS PERFORMED AGAIN. IT WAS NOT A CONTROL RELEASE NEEDLE. 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 23534005 ↗
• MalfunctionNov 3, 2025Break; Break

  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, IT WAS FOUND THAT THE SUTURE HAD BEEN BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. 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 23458180 ↗
• MalfunctionJun 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURES BREAK DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22204753 ↗
• MalfunctionJun 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURES BREAK DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22204752 ↗
• MalfunctionJun 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURES BREAK DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22204750 ↗
• MalfunctionApr 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOT-ASSISTED TOTAL GASTRECTOMY AND UROLIFT ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE HAD COME OFF DURING TRACTION ON THE SUTURE. THE TRACTION ON THE SUTURE MAY HAVE BEEN TOO STRONG, BUT IT IS VERY DANGEROUS FOR THE SUTURE TO COME OFF FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED 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 21772738 ↗
• MalfunctionDec 11, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20901471 ↗
• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BY A LSC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED TO FIX THE VAGINA AND MESH. POST-OP, THE PATIENT HAD A URINARY STONE AFTER THE SURGERY AND THE BLADDER WAS CHECKED TRANSURETHRAL SCOPICALLY WITH A CYSTOSCOPE. THE STUMP OF THE SUTURE THAT HAD BEEN USED TO SUTURE THE VAGINA TO THE MESH, WAS FOUND TO HAVE PENETRATED THE BLADDER. THE ADHESION OCCURRED ON THE STUMP AND DEVELOPED INTO STONES. THE PATIENT UNDER WENT RE-OPERATION. THE STONE WAS DRAINED TRANSURETHRAL SCOPICALLY AND CUT THE STUMP OF THE SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Adhesion(s); Unspecified Tissue Injury; Urolithiasis

  MAUDE report 20311209 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133356. One submission often covers many models, so check the product and lot details in each record.

• Z-1515-2025 · Mar 7, 2025 · Open, Classified
  PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
• Z-1096-2025 · Dec 20, 2024 · Open, Classified
  PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ca
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027

…and 6 more.