PROLENE 8698GRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10705031019232), received between Apr 23, 2019 and Apr 13, 2026 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Material Separation” (10 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Material Separation

  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, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. 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 24861918 ↗
• MalfunctionMar 31, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY DURING USE. IT WAS 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. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742818 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FACE AND NECK LIFT WITH PLATYSMAPLASTY WITH UPPER AND LOWER BLEPHAROPLASTY WITH DEEP PLANE MID FACELIFT ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE EYE LID. POST-OP, THE PATIENT DEVELOPED AN ATYPICAL MYCOBACTERIUM INFECTION. THE PATIENT WAS TREATED WITH BETAMETHASONE CREAM AND DOXYCYCLINE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Granuloma; Unspecified Infection

  MAUDE report 24417071 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FACE AND NECK LIFT WITH PLATYSMAPLASTY WITH UPPER AND LOWER BLEPHAROPLASTY WITH DEEP PLANE MID FACELIFT ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE EYE LID. POST-OP, THE PATIENT DEVELOPED AN ATYPICAL MYCOBACTERIUM INFECTION. THE PATIENT WAS TREATED WITH BETAMETHASONE CREAM AND DOXYCYCLINE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Granuloma; Unspecified Infection

  MAUDE report 24417026 ↗
• MalfunctionJun 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN KNEE PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE THAT THE NEEDLE POPPED OFF WHILE SUTURING A LACERATION OF THE LEFT KNEE. THIS HAPPENED ABOUT FIVE TIMES DURING THE PROCEDURE. ANOTHER LIKE DEVICE FROM A DIFFERENT BOX WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19604385 ↗
• MalfunctionJun 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN KNEE PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE THAT THE NEEDLE POPPED OFF WHILE SUTURING A LACERATION OF THE LEFT KNEE. THIS HAPPENED ABOUT FIVE TIMES DURING THE PROCEDURE. ANOTHER LIKE DEVICE FROM A DIFFERENT BOX WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19604378 ↗
• MalfunctionJun 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN KNEE PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE THAT THE NEEDLE POPPED OFF WHILE SUTURING A LACERATION OF THE LEFT KNEE. THIS HAPPENED ABOUT FIVE TIMES DURING THE PROCEDURE. ANOTHER LIKE DEVICE FROM A DIFFERENT BOX WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19604377 ↗
• MalfunctionJun 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN KNEE PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. DURING THE PROCEDURE THAT THE NEEDLE POPPED OFF WHILE SUTURING A LACERATION OF THE LEFT KNEE. THIS HAPPENED ABOUT FIVE TIMES DURING THE PROCEDURE. ANOTHER LIKE DEVICE FROM A DIFFERENT BOX WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19604375 ↗
• MalfunctionJun 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN KNEE PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE THAT THE NEEDLE POPPED OFF WHILE SUTURING A LACERATION OF THE LEFT KNEE. THIS HAPPENED ABOUT FIVE TIMES DURING THE PROCEDURE. ANOTHER LIKE DEVICE FROM A DIFFERENT BOX WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19604373 ↗
• MalfunctionDec 13, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN OTOLARYNGOLOGY/HEAD AND NECK SURGERY ON (B)(6) 2023 AND A SUTURE WAS USED. WHEN THE SURGEON WAS ABOUT TO SUTURE, THE SUTURE WAS BROKEN EASILY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18319198 ↗
• MalfunctionFeb 10, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DENTAL GRAFT PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE OPERATING STAFF HAD TO OPEN 4 PACKAGES AS THE SUTURE LINE WOULD BREAK OFF RENDERING THE DRIVER TOO SHORT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13510179 ↗
• MalfunctionMay 26, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT SKIN CANCER REMOVAL ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE CAME AWAY FROM THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11887997 ↗
• MalfunctionDec 9, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN USING THE SUTURE TO APPROXIMATE THE PATIENT'S SKIN, JUST AS THE SURGEON WAS TAKING THE FIRST BITE ON THE PATIENT'S SKIN AND WAS ABOUT TO PULL THE SUTURE, THE SUTURE FALLS OFF FROM THE NEEDLE. NO INFORMATION IS GIVEN REGARDING PATIENT INFORMATION AND THE IMPACTS ON THE OPERATION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10975497 ↗
• MalfunctionSep 18, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10556465 ↗
• MalfunctionSep 18, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10556464 ↗
• MalfunctionSep 18, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10556461 ↗
• MalfunctionSep 18, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10556460 ↗
• MalfunctionMay 7, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN CANCER EXCISION ON (B)(6) 2019 AND SUTURE WAS USED FOR CLOSURE. TOWARDS THE END OF THE PROCEDURE, THE SUTURE MATERIAL PULLED OUT FROM THE NEEDLE. ANOTHER LIKE DEVICE AS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8587888 ↗
• MalfunctionApr 23, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MOHS PROCEDURE ON AN UNKNOWN DATE IN 2019 AND SUTURE WAS USED. THE NEEDLE BROKE OFF FROM THE SUTURE DURING USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8541328 ↗

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-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• 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-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• 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-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-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• 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
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844

…and 6 more.