PROLENE 8418HRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705031015357), received between Nov 11, 2022 and Feb 2, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AM UNKNOWN PROCEDURE (B)(6) 2025 AND SUTURE WAS USED. NEEDLES POPPING OFF OF SUTURE TOO EASILY ACCORDING TO CLINICAL STAFF. MULTIPLE PACKAGES OPENED DURING CASE. 4 PACKAGES AVAILABLE FOR RETURN. THERE WERE NO SIGNIFICANT DELAYS REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24234598 ↗
• MalfunctionFeb 2, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AM UNKNOWN PROCEDURE (B)(6) 2025 AND SUTURE WAS USED. NEEDLES POPPING OFF OF SUTURE TOO EASILY ACCORDING TO CLINICAL STAFF. MULTIPLE PACKAGES OPENED DURING CASE. 4 PACKAGES AVAILABLE FOR RETURN. THERE WERE NO SIGNIFICANT DELAYS REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24234580 ↗
• MalfunctionAug 7, 2024Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE FRAYED AND SPLIT RIGHT DOWN THE MIDDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19930482 ↗
• MalfunctionAug 7, 2024Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19930479 ↗
• MalfunctionAug 7, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE, WITH BARELY ANY TENSION, THE SUTURE WAS FALLING OUT OF NEEDLE, BREAKING AT MULTIPLE SUTURE POINTS AND AT NEEDLE BASE. THE SUTURE WAS PASSED BACK AND THE NEEDLE TIP WAS GONE. THE SURGERY WAS PROLONGED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19928442 ↗
• MalfunctionAug 7, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE, WITH BARELY ANY TENSION, THE SUTURE WAS FALLING OUT OF NEEDLE, BREAKING AT MULTIPLE SUTURE POINTS AND AT NEEDLE BASE. THE SUTURE WAS PASSED BACK AND THE NEEDLE TIP WAS GONE. THE SURGERY WAS PROLONGED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19928441 ↗
• MalfunctionAug 7, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE, WITH BARELY ANY TENSION, THE SUTURE WAS FALLING OUT OF NEEDLE, BREAKING AT MULTIPLE SUTURE POINTS AND AT NEEDLE BASE. THE SUTURE WAS PASSED BACK AND THE NEEDLE TIP WAS GONE. THE SURGERY WAS PROLONGED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19928440 ↗
• MalfunctionAug 7, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE, WITH BARELY ANY TENSION, THE SUTURE WAS FALLING OUT OF NEEDLE, BREAKING AT MULTIPLE SUTURE POINTS AND AT NEEDLE BASE. THE SUTURE WAS PASSED BACK AND THE NEEDLE TIP WAS GONE. THE SURGERY WAS PROLONGED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19928439 ↗
• MalfunctionFeb 15, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE BROKE DURING ROUTINE USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16383610 ↗
• MalfunctionNov 11, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING OPERATING ROOM INVENTORY ON (B)(6) 2022, A SUTURE PACK WAS FOUND TO HAVE UNKNOWN FOREIGN MATERIAL INSIDE THE STERILE PACKAGE. THE SUTURE PACK WAS REMOVED FROM INVENTORY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15781282 ↗

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-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-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• 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-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• 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-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• 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
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067

…and 6 more.