PROLENE M8725Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10705031045910), received between Jul 15, 2019 and Jan 30, 2026 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (9 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE [REDACTED] REPORTED THE DEVICE, ITEM M8725 "STRINGS KEEP BREAKING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223293 ↗
• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE [REDACTED] REPORTED THE DEVICE, ITEM M8725 "STRINGS KEEP BREAKING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223290 ↗
• MalfunctionJul 2, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED WHEN THEY OPENED THE SUTURES, THERE'S M8726 INSIDE THE BOXES SUTURES. NOT THE CORRECT ONES. NO ADVERSE IMPACT PATIENT/USER. DEVICE IS AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22386962 ↗
• MalfunctionJul 2, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED WHEN THEY OPENED THE SUTURES, THERE'S M8726 INSIDE THE BOXES SUTURES. NOT THE CORRECT ONES. NO ADVERSE IMPACT PATIENT/USER. DEVICE IS AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22386959 ↗
• MalfunctionJul 2, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED WHEN THEY OPENED THE SUTURES, THERE'S M8726 INSIDE THE BOXES SUTURES. NOT THE CORRECT ONES. NO ADVERSE IMPACT PATIENT/USER. DEVICE IS AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22386958 ↗
• MalfunctionJul 2, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED WHEN THEY OPENED THE SUTURES, THERE'S M8726 INSIDE THE BOXES SUTURES. NOT THE CORRECT ONES. NO ADVERSE IMPACT PATIENT/USER. DEVICE IS AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22386957 ↗
• MalfunctionJul 2, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED WHEN THEY OPENED THE SUTURES, THERE'S M8726 INSIDE THE BOXES SUTURES. NOT THE CORRECT ONES. NO ADVERSE IMPACT PATIENT/USER. DEVICE IS AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22386955 ↗
• MalfunctionJul 2, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED WHEN THEY OPENED THE SUTURES, THERE'S M8726 INSIDE THE BOXES SUTURES. NOT THE CORRECT ONES. NO ADVERSE IMPACT PATIENT/USER. DEVICE IS AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22386954 ↗
• MalfunctionJul 2, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED WHEN THEY OPENED THE SUTURES, THERE'S M8726 INSIDE THE BOXES SUTURES. NOT THE CORRECT ONES. NO ADVERSE IMPACT PATIENT/USER. DEVICE IS AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22386953 ↗
• MalfunctionJul 2, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED WHEN THEY OPENED THE SUTURES, THERE'S M8726 INSIDE THE BOXES SUTURES. NOT THE CORRECT ONES. NO ADVERSE IMPACT PATIENT/USER. DEVICE IS AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22386952 ↗
• MalfunctionJul 2, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED WHEN THEY OPENED THE SUTURES, THERE'S M8726 INSIDE THE BOXES SUTURES. NOT THE CORRECT ONES. NO ADVERSE IMPACT PATIENT/USER. DEVICE IS AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22386951 ↗
• MalfunctionApr 8, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. BEFORE OPENING THE PACKAGE, IT WAS FOUND THAT THE STERILE PACKAGE HAD BEEN SEALED TOGETHER WITH THE PAPER PACKAGE INSIDE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19058205 ↗
• MalfunctionJul 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE DOCTOR WAS RUNNING THE SUTURE WITH AN IMPRA PATCH AND THE NEEDLES CAME OFF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17257755 ↗
• MalfunctionJul 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE DOCTOR WAS RUNNING THE SUTURE WITH AN IMPRA PATCH AND THE NEEDLES CAME OFF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17257250 ↗
• InjuryMar 23, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL SEPTAL DEFECT CLOSURE (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON TIED THE SUTURE WITH THE NEEDLE STILL ATTACHED. BY THE TIME THE SURGEON NOTICED, THE NEEDLE HAD COME OFF THE SUTURE AND WAS MISSING. THE SURGEON LOOKED FOR THE NEEDLE BUT COULD NOT FIND IT, SO THE SURGEON CLOSED THE CHEST ONCE AND TOOK AN X-RAY IN THE OPERATING ROOM. THEN THE NEEDLE WAS THEN FOUND, SO THE CHEST WAS OPENED AGAIN AND THE NEEDLE WAS REMOVED. THE SURGEON OPINED THERE WAS A CAUSAL RELATIONSHIP BETWEEN THE PRODUCT AND EVENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16598011 ↗
• MalfunctionDec 7, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE SURGERY WHILE USING THE SUTURE, MULTIPLE NEEDLES FELL OFF. THIS HAPPENED WITH 3 NEEDLES ON SUTURE FROM THE SAME MULTIPACK. AT THAT POINT A NEW BOX (NEW LOT #) WAS BROUGHT IN AND USED WITH NO FURTHER ISSUE, HOWEVER THERE WAS A SLIGHT DELAY IN THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15931888 ↗
• MalfunctionDec 7, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE SURGERY WHILE USING THE SUTURE, MULTIPLE NEEDLES FELL OFF. THIS HAPPENED WITH 3 NEEDLES ON SUTURE FROM THE SAME MULTIPACK. AT THAT POINT A NEW BOX (NEW LOT #) WAS BROUGHT IN AND USED WITH NO FURTHER ISSUE, HOWEVER THERE WAS A SLIGHT DELAY IN THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15931830 ↗
• MalfunctionDec 7, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE SURGERY WHILE USING THE SUTURE, MULTIPLE NEEDLES FELL OFF. THIS HAPPENED WITH 3 NEEDLES ON SUTURE FROM THE SAME MULTIPACK. AT THAT POINT A NEW BOX (NEW LOT#:) WAS BROUGHT IN AND USED WITH NO FURTHER ISSUE, HOWEVER THERE WAS A SLIGHT DELAY IN THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15931817 ↗
• MalfunctionSep 6, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2022 AND SUTURE WAS USED. IT WAS FOUND THAT THERE WAS A FOREIGN SUBSTANCE IN THE STERILE PACKAGE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15366416 ↗
• MalfunctionDec 17, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. A FOREIGN SUBSTANCE LIKE A HAIR WAS FOUND IN THE PACKAGE WHEN THE PACKAGE WAS OPENED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9485471 ↗
• MalfunctionDec 12, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A CARDIOVASCULAR PROCEDURE SOME SUTURES WERE BROKEN EASILY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9459472 ↗
• MalfunctionDec 12, 2019Material Separation; Material Separation

  IT WAS REPORTED BY THE SALES REP THAT DURING A CARDIOVASCULAR PROCEDURE SOME SUTURES WERE NOT SWAGED FIRMLY, CAUSING SUTURES TO COME OFF THE NEEDLES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9459452 ↗
• MalfunctionJul 15, 2019Break; Break

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8789921 ↗

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-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• 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-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• 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

…and 6 more.