PROLENE W8802Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031128361), received between Aug 14, 2024 and May 8, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING ANASTOMOSIS, THE SURGEON NOTICED THAT AFTER MAKING SEVERAL PASSES WITH THE SUTURE THROUGH THE BLOOD VESSEL, THE NEEDLE DISCONNECTED FROM THE SUTURE. THERE WAS A DELAY OF SEVERAL MINUTES IN THE PROCEDURE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT HARM TO THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21989208 ↗
• MalfunctionMay 8, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING ANASTOMOSIS, THE SURGEON NOTICED THAT AFTER MAKING SEVERAL PASSES WITH THE SUTURE THROUGH THE BLOOD VESSEL, THE NEEDLE DISCONNECTED FROM THE SUTURE. THERE WAS A DELAY OF SEVERAL MINUTES IN THE PROCEDURE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT HARM TO THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21989194 ↗
• MalfunctionMay 8, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING ANASTOMOSIS, THE SURGEON NOTICED THAT AFTER MAKING SEVERAL PASSES WITH THE SUTURE THROUGH THE BLOOD VESSEL, THE NEEDLE DISCONNECTED FROM THE SUTURE. THERE WAS A DELAY OF SEVERAL MINUTES IN THE PROCEDURE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT HARM TO THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21989182 ↗
• MalfunctionJan 27, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN THE VASCULAR THEATRE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURES HAD BEEN BREAKING, EITHER THE THREAD WHEN USED OR COMING OUT OF THE PACKET IN TWO PARTS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21245797 ↗
• MalfunctionAug 14, 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, FIRST NEEDLE SNAPPED AWAY FROM SUTURE UPON TYING. SECOND NEEDLE SNAPPED WHILE SUTURING. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19986341 ↗
• MalfunctionAug 14, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, FIRST NEEDLE SNAPPED AWAY FROM SUTURE UPON TYING. SECOND NEEDLE SNAPPED WHILE SUTURING. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19986274 ↗

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-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292

…and 6 more.