PROLENE W8702Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705031201903), received between Aug 22, 2024 and Aug 18, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50299874 ↗
• MalfunctionAug 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50299871 ↗
• MalfunctionJan 21, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE DETACHED FROM THE SUTURE DURING PASSAGE THROUGH TISSUE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24136906 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ONE TUBE FOR ALL: 1-YEAR OUTCOMES AFTER TRANSITION TO PAUL GLAUCOMA IMPLANT AT A TERTIARY CENTRE. THE AIM OF THIS PROSPECTIVE OBSERVATIONAL STUDY WAS TO EVALUATE THE INTRAOCULAR PRESSURE (IOP) LOWERING EFFECT AND SUCCESS RATE OF PAUL GLAUCOMA IMPLANT (PGI) IN REFRACTORY GLAUCOMA AFTER CHANGING PRACTICE PATTERN FROM AHMED AND BAERVELDT TUBES TO PGI. FROM JANUARY 2022 TO OCTOBER 2023, A TOTAL OF 49 PATIENTS WERE INCLUDED IN THE STUDY. CONSISTS OF 38 MALE AND 11 FEMALE. WITH THE MEAN AGE OF 66.5 ± 16.9 AND RANGE 13¿85 YEARS. THE DEVICES USED DURING THE SURGERY WERE ETHILON 8¿0-9/0 (ETHICON),VICRYL 7¿0 (ETHICON) AND PROLENE 7¿0 (ETHICON) ,VISCOAT (ALCON LABORATORIES, TEXAS, USA) WAS INJECTED IN THE AC OR HEALON GV PRO (JOHNSON & JOHNSON, CALIFORNIA, USA) BEHIND THE IRIS IN CASES WITH PLACEMENT IN THE SULCUS. REPORTED COMPLICATIONS ETHILON 8¿0-9/0 (ETHICON), VICRYL 7¿0 (ETHICON), PROLENE 7¿0 (ETHICON) . LOSS OF ACUITY (N=?), TREATMENT: NOT REPORTED. CATARACT PROGRESSION (N=?) TREATMENT: NOT REPORTED. CLINICAL HYPOTONY (N=?) TREATMENT: NOT REPORTED. CHOROIDAL DETACHMENT (N=?) TREATMENT: NOT REPORTED. BCVA LOSS (N=?) TREATMENT: NOT REPORTED. MACULOPATHY (N=?) TREATMENT: NOT REPORTED. AC S

  Patient problems: Eye Injury; Hyphema; Insufficient Information

  MAUDE report 23064758 ↗
• MalfunctionSep 5, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WAS ALERTED BY SR <NURSE'S NAME> THAT 1 EA OF SUTURE SNAPPED DURING DR <DOCTOR'S NAME>'S CASE. 2ND PIECE WAS OPENED TO CONTINUE WITH THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22977363 ↗
• MalfunctionNov 21, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. THE SUTURE WAS EASILY BROKEN DURING SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20748593 ↗
• MalfunctionNov 21, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. THE SUTURE WAS EASILY BROKEN DURING SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20748361 ↗
• MalfunctionNov 21, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. THE SUTURE WAS EASILY BROKEN DURING SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20748348 ↗
• MalfunctionNov 21, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. THE SUTURE WAS EASILY BROKEN DURING SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20748315 ↗
• MalfunctionNov 14, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURES SNAPPING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683351 ↗
• MalfunctionOct 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE IS COMING OFF THE THREAD DURING SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20402769 ↗
• MalfunctionAug 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE GETTING DETACHED FROM SWAGE POINT. THERE WERE NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20042070 ↗

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-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067

…and 6 more.