PROLENE 8720HRecalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 10705031019706), received between Jul 9, 2019 and Nov 17, 2025 — classified as 70 malfunctions.

The most frequently reported specific device problem is “Material Separation” (35 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 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE DETACHED FROM NEEDLE. FRAGMENT OF SUTURE AND NEEDLE WERE RECOVERED. THE PROCEDURE WAS CLOSED WITHOUT HARM TO PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23575703 ↗
• MalfunctionNov 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE DETACHED FROM NEEDLE. FRAGMENT OF SUTURE AND NEEDLE WERE RECOVERED. THE PROCEDURE WAS CLOSED WITHOUT HARM TO PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23575202 ↗
• MalfunctionAug 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE WAS RELEASED FROM THE NEEDLE TWO DIFFERENT TIMES WHEN USING THE PRODUCT. THE PRODUCT HAS TWO NEEDLES, AND ONE OF THE NEEDLES RELEASED BOTH TIMES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22698493 ↗
• MalfunctionAug 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE WAS RELEASED FROM THE NEEDLE TWO DIFFERENT TIMES WHEN USING THE PRODUCT. THE PRODUCT HAS TWO NEEDLES, AND ONE OF THE NEEDLES RELEASED BOTH TIMES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22698491 ↗
• MalfunctionJun 9, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SUTURES BREAKING. SEVERAL STRANDS FROM THE SAME LOT NUMBER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22169948 ↗
• MalfunctionJun 9, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SUTURES BREAKING. SEVERAL STRANDS FROM THE SAME LOT NUMBER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22169911 ↗
• MalfunctionMar 18, 2025Material Discolored; Device Markings/Labelling Problem; Material Discolored; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED IT WAS REPORTED THAT THE NURSE WENT TO PULL WHAT SHE BELIEVES WAS AN 8720H SUTURE, HOWEVER, THE ONE THEY PULLED OUT OF THE BOX HAD BLACK NEEDLES, BUT OTHERWISE MATCHED THE DESCRIPTION OF THE 8720H. THEY USED THE SUTURE ANYWAYS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21634425 ↗
• MalfunctionAug 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE DESWAGED ON ROUTINE USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064350 ↗
• MalfunctionAug 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE DESWAGED ON ROUTINE USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064348 ↗
• MalfunctionApr 30, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024, AND SUTURE WAS USED. DURING THE SURGERY, THE SUTURES HAD BEEN BROKEN AND THE NEEDLES HAD BEEN DETACHED OFTEN ONLY IN THIS LOT NUMBER. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS HAVE BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19213267 ↗
• MalfunctionApr 30, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024, AND SUTURE WAS USED. DURING THE SURGERY, THE SUTURES HAD BEEN BROKEN AND THE NEEDLES HAD BEEN DETACHED OFTEN ONLY IN THIS LOT NUMBER. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS HAVE BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19212907 ↗
• MalfunctionApr 30, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024, AND SUTURE WAS USED. DURING THE SURGERY, THE SUTURES HAD BEEN BROKEN AND THE NEEDLES HAD BEEN DETACHED OFTEN ONLY IN THIS LOT NUMBER. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS HAVE BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19212795 ↗
• MalfunctionNov 6, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND A SUTURE WAS USED. IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMER OPENED A NEW BOX OF SUTURES AND HAVE FOUND THAT THE FIRST THREE PACKETS ARE DEFECTIVE. THEY SUTURE IS BREAKING PREMATURELY. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18080039 ↗
• MalfunctionNov 6, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND A SUTURE WAS USED. IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMER OPENED A NEW BOX OF SUTURES AND HAVE FOUND THAT THE FIRST THREE PACKETS ARE DEFECTIVE. THEY SUTURE IS BREAKING PREMATURELY. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18079680 ↗
• MalfunctionNov 6, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND A SUTURE WAS USED. IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMER OPENED A NEW BOX OF SUTURES AND HAVE FOUND THAT THE FIRST THREE PACKETS ARE DEFECTIVE. THEY SUTURE IS BREAKING PREMATURELY. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18079677 ↗
• MalfunctionAug 17, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT OPEN HEART SURGERY, BENTAL PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. WHILE DOING PROCEDURE AND HALF-WAY WHEN DOING THE SUTURING, THE SUTURE SNAPPED. NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17563385 ↗
• MalfunctionJul 6, 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, AFTER USING THE PRODUCT, WHEN THE SURGEON RETURNED THE PRODUCT WHILE HOLDING THE SUTURE TO A SCRUB NURSE, ONE NEEDLE FLEW OUTSIDE THE SURGICAL FIELD. THE NEEDLE WAS IMMEDIATELY FOUND. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17266740 ↗
• MalfunctionMay 24, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD DETACHED FROM THE NEEDLE WHEN SUTURING THE VESSELS. THERE WAS A 5 MINUTE DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16995514 ↗
• MalfunctionApr 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE DETACHED FROM SWAGE AFTER FIRST BITE. ANOTHER PACK USED WAS FINE AND WAS USED TO COMPLETE THE ANASTOMOSES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16681090 ↗
• MalfunctionApr 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE DETACHED FROM SWAGE AFTER FIRST BITE. ANOTHER PACK USED WAS FINE AND WAS USED TO COMPLETE THE ANASTOMOSES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16681089 ↗
• MalfunctionMar 31, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTEROSCOPIC TUBAL LIGATION AND RECANALIZATION PROCEDURE ON (B)(6) 2023, AND SUTURE WAS USED. THE SUTURE WAS USED TO SUTURE THE FALLOPIAN TUBE. DURING TYING, THE SUTURE WAS BROKEN THREE TIMES. CHANGED TO ANOTHER ONE TO CONTINUE THE HYSTEROSCOPIC TUBAL LIGATION AND RECANALIZATION SURGERY, THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16657382 ↗
• MalfunctionMar 31, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTEROSCOPIC TUBAL LIGATION AND RECANALIZATION PROCEDURE ON (B)(6), 2023, AND SUTURE WAS USED. THE SUTURE WAS USED TO SUTURE THE FALLOPIAN TUBE. DURING TYING, THE SUTURE WAS BROKEN THREE TIMES. CHANGED TO ANOTHER ONE TO CONTINUE THE HYSTEROSCOPIC TUBAL LIGATION AND RECANALIZATION SURGERY, THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16656501 ↗
• MalfunctionMar 31, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTEROSCOPIC TUBAL LIGATION AND RECANALIZATION PROCEDURE ON (B)(6) 2023, AND SUTURE WAS USED. THE SUTURE WAS USED TO SUTURE THE FALLOPIAN TUBE. DURING TYING, THE SUTURE WAS BROKEN THREE TIMES. CHANGED TO ANOTHER ONE TO CONTINUE THE HYSTEROSCOPIC TUBAL LIGATION AND RECANALIZATION SURGERY, THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16656496 ↗
• MalfunctionMar 31, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTEROSCOPIC TUBAL LIGATION AND RECANALIZATION PROCEDURE ON (B)(6) 2023, AND SUTURE WAS USED. THE SUTURE WAS USED TO SUTURE THE FALLOPIAN TUBE. DURING TYING, THE SUTURE WAS BROKEN THREE TIMES. CHANGED TO ANOTHER ONE TO CONTINUE THE HYSTEROSCOPIC TUBAL LIGATION AND RECANALIZATION SURGERY, THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16656491 ↗
• MalfunctionJan 4, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THAT SUTURES WERE POPPING OFF. UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THE SUTURE BECAME DETACHED FROM THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16098897 ↗

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-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• 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-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• 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-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988

…and 6 more.