PROLENE 8711HRecalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 10705031019560), received between May 29, 2018 and May 26, 2026 — classified as 3 injuries, 86 malfunctions.

The most frequently reported specific device problem is “Break” (48 reports).

1 FDA recall record name this device's identifier, 1 still open.

20 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.

Recalls naming this device

1. Mar 7, 2025Open, Classified

   Identified curing issues with the silicone during the needles manufacturing process.

   Z-1515-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 89 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR ANASTOMOSIS PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING VASCULAR ANASTOMOSIS SURGERY NEEDLES CAME OFF WITHOUT ANY FORCE. NEW SUTURE WAS TAKEN AND SURGICAL ANASTOMOSIS ENDED. THERE WERE SURGICAL DELAYS REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25280860 ↗
• MalfunctionMay 26, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR ANASTOMOSIS PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING VASCULAR ANASTOMOSIS SURGERY NEEDLES CAME OFF WITHOUT ANY FORCE. NEW SUTURE WAS TAKEN AND SURGICAL ANASTOMOSIS ENDED. THERE WERE SURGICAL DELAYS REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25280846 ↗
• MalfunctionMay 11, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS ALERTED BY DISTRIBUTOR FLEMMING THAT ONE OF THEIR CUSTOMERS - APTUS AT PARAGON - EXPERIENCED A DEFECTIVE SUTURE. DR [NAME REDACTED] WAS IN THE MIDST OF HIS PROCEDURE (CREATION OF ARTERIO-VENOUS FISTULA AND ANGIOGRAPHY) AND EXPERIENCED SUTURE BREAKAGE IN THE MIDDLE OF THE SUTURE FOR 2 TIMES. 3RD PACKET WAS OPENED AND WAS OKAY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25136922 ↗
• MalfunctionMay 11, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS ALERTED BY DISTRIBUTOR FLEMMING THAT ONE OF THEIR CUSTOMERS - APTUS AT PARAGON - EXPERIENCED A DEFECTIVE SUTURE. DR [NAME REDACTED] WAS IN THE MIDST OF HIS PROCEDURE (CREATION OF ARTERIO-VENOUS FISTULA AND ANGIOGRAPHY) AND EXPERIENCED SUTURE BREAKAGE IN THE MIDDLE OF THE SUTURE FOR 2 TIMES. 3RD PACKET WAS OPENED AND WAS OKAY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25136904 ↗
• MalfunctionSep 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN SEWING, THE NEEDLE WOULD COME OFF THE THREAD TOO EASILY. WITH THREADS FROM ANOTHER BATCH, THE OPERATION WAS CONTINUED AND COMPLETED AS PLANNED. NO PATIENT HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23145237 ↗
• MalfunctionMar 5, 2025Material 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 NEEDLE BROKE OFF FROM THE WIRE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21530220 ↗
• MalfunctionDec 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING A SURGERY, CONSECUTIVELY 4 SUTURES WERE OPENED AND THE NEEDLE BROKE OFF. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20913004 ↗
• MalfunctionDec 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING A SURGERY, CONSECUTIVELY 4 SUTURES WERE OPENED AND THE NEEDLE BROKE OFF. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20912959 ↗
• MalfunctionDec 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING A SURGERY, CONSECUTIVELY 4 SUTURES WERE OPENED AND THE NEEDLE BROKE OFF. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20912898 ↗
• MalfunctionDec 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING A SURGERY, CONSECUTIVELY 4 SUTURES WERE OPENED AND THE NEEDLE BROKE OFF. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20912780 ↗
• MalfunctionNov 22, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS FOUND AT SPD THAT THERE HAD BEEN A FOREIGN MATTER IN THE STERILIZATION PACKAGE. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20761740 ↗
• MalfunctionOct 31, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PEDIATRIC CARDIAC SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE THREAD WHILE SUTURING THE TISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20582550 ↗
• MalfunctionOct 31, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PEDIATRIC CARDIAC SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE THREAD WHILE SUTURING THE TISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20582407 ↗
• MalfunctionSep 4, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON HAS HAD MULTIPLE SUTURES POP OFF THE NEEDLE DURING SURGERY. THE LOADING OF THE SUTURE WAS LOOKED AT AND IT WAS BEING DONE PROPERLY, AWAY FROM THE SWAGE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20135380 ↗
• MalfunctionSep 4, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON HAS HAD MULTIPLE SUTURES POP OFF THE NEEDLE DURING SURGERY. THE LOADING OF THE SUTURE WAS LOOKED AT AND IT WAS BEING DONE PROPERLY, AWAY FROM THE SWAGE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20135379 ↗
• MalfunctionAug 13, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE THAT SEVERAL SUTURES OF THE SAME LOT BROKE. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19974282 ↗
• MalfunctionAug 13, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE THAT SEVERAL SUTURES OF THE SAME LOT BROKE. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19974280 ↗
• MalfunctionAug 13, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE THAT SEVERAL SUTURES OF THE SAME LOT BROKE. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19974180 ↗
• MalfunctionAug 13, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE THAT SEVERAL SUTURES OF THE SAME LOT BROKE. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19974161 ↗
• MalfunctionAug 13, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE THAT SEVERAL SUTURES OF THE SAME LOT BROKE. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19974160 ↗
• MalfunctionAug 7, 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 WIRE IS DETACHED FROM THE NEEDLE WHEN PASSING THE POINT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19929644 ↗
• MalfunctionJul 12, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KEPT BREAKING. NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19729870 ↗
• MalfunctionJul 12, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KEPT BREAKING. NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19729867 ↗
• MalfunctionJun 7, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON 10-MAY-2024 AND SUTURE WAS USED. THE NEEDLE BROKE DURING USE. THEY GOT A NEW ONE TO CONTINUE WITH THE REST OF THE CASE WITHOUT PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19485945 ↗
• MalfunctionJun 7, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE NON-POP OFF NEEDLE, POPPED OFF DURING USE. THEY GOT A NEW ONE TO CONTINUE WITH THE REST OF THE CASE WITHOUT PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19482828 ↗

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-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-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• 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-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• 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-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981

…and 5 more.