PROLENE 8701HRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705031019294), received between May 2, 2019 and Mar 23, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN CARDIOVASCULAR SURGERY, THE SUTURE WAS BROKEN EVEN THOUGH THERE WAS NO TENSION APPLIED. IT WAS A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED 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 24664998 ↗
• MalfunctionNov 11, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN VASCULAR PROCEDURE, THE DOCTOR STATED THAT HE HAD ISSUES WITH A FEW SUTURES THAT KEEP BREAKING AT EVERY POINT, THE END AND THE SWAGE AND WHEN HE'S TYING HIS KNOTS. CASE WAS COMPLETED. NO PATIENT HARM REPORTED. STERILE PRODUCT BEING RETURNED FROM SAME LOT, USED SUTURES DISCARDED. DID MENTIONED THAT THIS HAS HAPPENED BEFORE IN OTHER CASES WITH THE SAME PRODUCT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20653348 ↗
• MalfunctionNov 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN VASCULAR PROCEDURE, THE DOCTOR STATED THAT HE HAD ISSUES WITH A FEW SUTURES THAT KEEP BREAKING AT EVERY POINT, THE END AND THE SWAGE AND WHEN HE'S TYING HIS KNOTS. CASE WAS COMPLETED. NO PATIENT HARM REPORTED. STERILE PRODUCT BEING RETURNED FROM SAME LOT, USED SUTURES DISCARDED. DID MENTIONED THAT THIS HAS HAPPENED BEFORE IN OTHER CASES WITH THE SAME PRODUCT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20653327 ↗
• MalfunctionNov 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN VASCULAR PROCEDURE, THE DOCTOR STATED THAT HE HAD ISSUES WITH A FEW SUTURES THAT KEEP BREAKING AT EVERY POINT, THE END AND THE SWAGE AND WHEN HE'S TYING HIS KNOTS. CASE WAS COMPLETED. NO PATIENT HARM REPORTED. STERILE PRODUCT BEING RETURNED FROM SAME LOT, USED SUTURES DISCARDED. DID MENTIONED THAT THIS HAS HAPPENED BEFORE IN OTHER CASES WITH THE SAME PRODUCT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20653101 ↗
• MalfunctionNov 11, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN VASCULAR PROCEDURE, THE DOCTOR STATED THAT HE HAD ISSUES WITH A FEW SUTURES THAT KEEP BREAKING AT EVERY POINT, THE END AND THE SWAGE AND WHEN HE'S TYING HIS KNOTS. CASE WAS COMPLETED. NO PATIENT HARM REPORTED. STERILE PRODUCT BEING RETURNED FROM SAME LOT, USED SUTURES DISCARDED. DID MENTIONED THAT THIS HAS HAPPENED BEFORE IN OTHER CASES WITH THE SAME PRODUCT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20653076 ↗
• MalfunctionJun 18, 2024Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A CABG PROCEDURE THAT THESE TWO SUTURES SEEMS TO BE VERY BRITTLE AND ARE BREAKING. THEY HAVE HAD TO WET THE SUTURE AND TIE EXTRA KNOTS. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19560085 ↗
• MalfunctionJun 18, 2024Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A CABG PROCEDURE THAT THESE TWO SUTURES SEEMS TO BE VERY BRITTLE AND ARE BREAKING. THEY HAVE HAD TO WET THE SUTURE AND TIE EXTRA KNOTS. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19560001 ↗
• MalfunctionMay 20, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE WAS BROKEN FROM THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19351025 ↗
• MalfunctionDec 4, 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, IT WAS REPORTED BY A SALES REP THAT, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY DURING CONTINUOUS SUTURE. 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 18264044 ↗
• MalfunctionMar 29, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. SUTURE WAS BROKEN DURING USE. THE PRODUCT WAS DISCARDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16637195 ↗
• MalfunctionJun 29, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SHUNT EXPANSION SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING VASCULAR ANASTOMOSIS, THE SUTURE BROKE EASILY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12084635 ↗
• MalfunctionJun 29, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SHUNT EXPANSION SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING VASCULAR ANASTOMOSIS, THE SUTURE BROKE EASILY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12084629 ↗
• MalfunctionOct 27, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE TOO EASILY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10741922 ↗
• MalfunctionDec 12, 2019Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CABG PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED TO SUTURE ANASTOMOSIS. DURING THE PROCEDURE, THE SUTURE MAY HAVE BROKEN AND SUTURE MAY HAVE UNRAVELED. A SUTURE THAT UNRAVELED WAS AROUND THE AORTA AND THE SURGEON SPOTTED THIS BEFORE CLOSING. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9461210 ↗
• MalfunctionMay 2, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8575591 ↗

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-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• 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-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• 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-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995

…and 6 more.