PROLENE 8776HRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10705031020481), received between Jun 22, 2018 and Feb 6, 2026 — classified as 1 death, 24 malfunctions.

The most frequently reported specific device problem is “Material Separation” (12 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN VASCULAR PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, DURING AN OPEN-CHEST SURGERY, THE SUTURE WAS BROKEN IN THE MIDDLE WHEN THE PRODUCT WAS USED DURING A VASCULAR ANASTOMOSIS. IT WAS OCCURRED WITH 2 SUTURES IN A ROW DESPITE THE OPERATION BEING PERFORMED USING THE SAME PROCEDURE AS USUAL. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WAS NO EFFECT ON THE PATIENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279169 ↗
• MalfunctionFeb 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN VASCULAR PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, DURING AN OPEN-CHEST SURGERY, THE SUTURE WAS BROKEN IN THE MIDDLE WHEN THE PRODUCT WAS USED DURING A VASCULAR ANASTOMOSIS. IT OCCURRED WITH 2 SUTURES IN A ROW DESPITE THE OPERATION BEING PERFORMED USING THE SAME PROCEDURE AS USUAL. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WAS NO EFFECT ON THE PATIENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279168 ↗
• MalfunctionAug 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A CABG PROCEDURE, THE SUTURE KEPT BREAKING. 4 PACKS WERE OPENED. THE 2994 CONNECTOR SNAPPED AND A NEW BOX WAS OPENED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. DEVICES WERE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737586 ↗
• MalfunctionAug 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A CABG PROCEDURE, THE SUTURE KEPT BREAKING. 4 PACKS WERE OPENED. THE 2994 CONNECTOR SNAPPED AND A NEW BOX WAS OPENED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. DEVICES WERE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737516 ↗
• MalfunctionAug 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A CABG PROCEDURE, THE SUTURE KEPT BREAKING. 4 PACKS WERE OPENED. THE 2994 CONNECTOR SNAPPED AND A NEW BOX WAS OPENED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. DEVICES WERE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737511 ↗
• MalfunctionJun 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLES HAD COME LOOSE FROM THE THREAD AFTER BEING CLAMPED TWICE. THEY HAD TO BE SEARCHED BY X-RAY BUT WERE FOUND ACCORDINGLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559971 ↗
• MalfunctionJun 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLES HAD COME LOOSE FROM THE THREAD AFTER BEING CLAMPED TWICE. THEY HAD TO BE SEARCHED BY X-RAY, BUT WERE FOUND ACCORDINGLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559966 ↗
• MalfunctionMar 27, 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, THE NEEDLES TEAR OFF THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18986215 ↗
• MalfunctionMar 27, 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, THE NEEDLES TEAR OFF THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18986211 ↗
• MalfunctionMar 27, 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, THE NEEDLES TEAR OFF THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18986209 ↗
• MalfunctionMar 11, 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, THE NEEDLES TEAR OFF THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18877283 ↗
• MalfunctionMar 11, 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, THE NEEDLES TEAR OFF THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18877278 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2024; AND A SUTURE WAS USED. THE NEEDLE TORE OFF THE SUTURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841273 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. THE NEEDLE TORE OFF THE SUTURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841260 ↗
• MalfunctionJan 12, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT PANCREATICODUODENECTOMY: PD ON AN UNKNOWN DATE AND SUTURE WAS USED, DURING THE PROCEDURE, THE SUTURE WAS TORN WHILE BEING USED FOR THE ANASTOMOSIS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18503553 ↗
• MalfunctionNov 20, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE OF A SUTURE USED IN SURGERY BROKE DURING INTERVENTION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18176611 ↗
• MalfunctionApr 15, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE OFF FROM THE NEEDLE LIKE A POP OFF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11673603 ↗
• MalfunctionApr 15, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE OFF FROM THE NEEDLE LIKE A POP OFF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11673596 ↗
• MalfunctionFeb 22, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. WHEN SUTURING ON THE CORONARY ARTERY, THE SUTURE WAS BROKEN EASILY. FURTHER DETAILS ARE NOT PROVIDED FROM THE HEALTHCARE PROVIDER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11358049 ↗
• DeathJan 11, 2021Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KIDNEY TRANSPLANT ON (B)(6) 2020 AND SUTURE WAS USED. THE SUTURE WAS USED IN A RUNNING FASHION TO PERFORM BOTH THE VENOUS AND THE ARTERIAL ANASTOMOSIS AND TWO SUTURES WERE USED ON EACH ANASTOMOSIS. THERE WERE NO ISSUES REPORTED BY THE SURGEON AT THE TIME OF SURGERY. THE PATIENT WAS SUBSEQUENTLY DISCHARGED HOME AFTER A REPORTED NORMAL COURSE. THE PATIENT RETURNED TO THE EMERGENCY ROOM ON OR ABOUT (B)(6) 2020 WITH REPORTED "BLEEDING FROM HER INCISION". THE SURGEON OPENED THE INCISION AND INSPECTED THE ANASTOMOSIS AND DISCOVERED THAT ONE OF THE ARTERIAL ANASTOMOSIS SUTURE LINES HAD "EITHER FRACTURED OR COME LOOSE" AND HAD "UNRAVELED". ACCORDING TO THE SURGEON, THE PATIENT EXPIRED DURING THE EMERGENCY SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11151790 ↗
• MalfunctionJun 11, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AORTO BI-PROSTHESIS PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN NEEDLE PENETRATED TISSUE. THE SURGEON NEEDED TWO SUTURES TO FINISH THE ANASTOMOSIS. THERE WERE NO PATIENT CONSEQUENCES REPORTED, JUST A NOT SIGNIFICANT SURGERY TIME EXTENSION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10145467 ↗
• MalfunctionJun 11, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AORTO BI-PROSTHESIS PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN NEEDLE PENETRATED TISSUE. THE SURGEON NEEDED TWO SUTURES TO FINISH THE ANASTOMOSIS. THERE WERE NO PATIENT CONSEQUENCES REPORTED, JUST A NOT SIGNIFICANT SURGERY TIME EXTENSION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10145463 ↗
• MalfunctionOct 14, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2019 AND SUTURE WAS USED. THE NEEDLE IS POPPING OFF OF THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9187425 ↗
• MalfunctionJun 22, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN AORTIC VALVE REPAIR PROCEDURE IN 2018 AND THE SUTURE WAS USED. DURING THE PROCEDURE, AFTER TWO TO THREE STITCHES, THE NEEDLE SEPARATED FROM THE SUTURE AND WAS RETRIEVED IMMEDIATELY. NO ADDITIONAL SURGERY WAS NECESSARY. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7630159 ↗
• MalfunctionJun 22, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN AORTIC VALVE REPAIR PROCEDURE IN 2018 AND THE SUTURE WAS USED. DURING THE PROCEDURE, AFTER TWO TO THREE STITCHES, THE NEEDLE SEPARATED FROM THE SUTURE AND WAS RETRIEVED IMMEDIATELY. NO ADDITIONAL SURGERY WAS NECESSARY. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7630119 ↗

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-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189

…and 6 more.