PROLENE 8806HRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10705031020696), received between Jul 3, 2019 and Sep 18, 2026 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Material Separation” (17 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50827986 ↗
• MalfunctionDec 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE BROKE. THERE WERE NO PATIENT ADVERSE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706791 ↗
• MalfunctionAug 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE SURGEON THAT THE SUTURE ITSELF KEEPS BREAKING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22914398 ↗
• MalfunctionAug 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE SURGEON THAT THE SUTURE ITSELF KEEPS BREAKING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22914397 ↗
• MalfunctionAug 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE SURGEON THAT THE SUTURE ITSELF KEEPS BREAKING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22914395 ↗
• MalfunctionMay 8, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. THE SUTURE WAS BREAKING INTER OPERATIVELY. NO ADVERSE IMPACT PATIENT/USER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21989643 ↗
• MalfunctionAug 28, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AV FISTULA ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. ANOTHER SUTURE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE WITHOUT PATIENT HARM. THE SURGEON NOTICED THE DIFFERENCE WHEN A SUTURE FROM A DIFFERENT LOT WAS PULLED AFTER THE DEFECTIVE SUTURE BROKE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20087188 ↗
• MalfunctionAug 28, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AV FISTULA ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. ANOTHER SUTURE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE WITHOUT PATIENT HARM. THE SURGEON NOTICED THE DIFFERENCE WHEN A SUTURE FROM A DIFFERENT LOT WAS PULLED AFTER THE DEFECTIVE SUTURE BROKE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20086952 ↗
• MalfunctionAug 28, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AV FISTULA ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. ANOTHER SUTURE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE WITHOUT PATIENT HARM. THE SURGEON NOTICED THE DIFFERENCE WHEN A SUTURE FROM A DIFFERENT LOT WAS PULLED AFTER THE DEFECTIVE SUTURE BROKE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20086942 ↗
• MalfunctionAug 28, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AV FISTULA ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. ANOTHER SUTURE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE WITHOUT PATIENT HARM. THE SURGEON NOTICED THE DIFFERENCE WHEN A SUTURE FROM A DIFFERENT LOT WAS PULLED AFTER THE DEFECTIVE SUTURE BROKE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20086940 ↗
• MalfunctionAug 28, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AV FISTULA ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. ANOTHER SUTURE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE WITHOUT PATIENT HARM. THE SURGEON NOTICED THE DIFFERENCE WHEN A SUTURE FROM A DIFFERENT LOT WAS PULLED AFTER THE DEFECTIVE SUTURE BROKE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20086935 ↗
• MalfunctionApr 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A FISTULA PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2024 AND SUTURE WAS USED. THERE WERE TWO INSTANCES OF THE NEEDLES (A DOUBLE -ENDED SUTURE) BECOMING DETACHED FROM THE SUTURE ITSELF, FROM THE SAME BOX. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19070178 ↗
• MalfunctionApr 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A FISTULA PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THERE WERE TWO DIFFERENT INSTANCES OF ONE OF THE NEEDLES (A DOUBLE-ENDED SUTURE) BECAME DETACHED FROM THE SUTURE ITSELF FROM THE SAME BOX. THE HOSPITAL THOUGHT THE NEEDLE HAD GOTTEN STUCK ON A DRAPE OR SOMETHING SO THEY DIDN'T PAY ATTENTION UNTIL THE SAME THING HAPPENED WITH A SUTURE FROM THE SAME BOX IN AN AV FISTULA PROCEDURE SOON AFTER. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19070175 ↗
• MalfunctionSep 13, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. WHILE CLOSING OPENING AFTER SURGICAL CASE, DURING A CASE THE SUTURE NEEDLE 6-0 POPPED OFF THE SUTURE AND WAS LOST. XRAY COMPLETED AND IT WAS NOT IN THE PATIENT BUT THE NEEDLE WAS NOT RECOVERED. NO PATIENT HARM WAS REPORTED. DEVICE IS NOT AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17735208 ↗
• MalfunctionJun 28, 2022Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE CONNECTION PART BETWEEN THE SUTURE AND THE NEEDLE WAS EASILY DETACHED. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14843622 ↗
• MalfunctionJun 28, 2022Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE CONNECTION PART BETWEEN THE SUTURE AND THE NEEDLE WAS EASILY DETACHED. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14843612 ↗
• MalfunctionJun 28, 2022Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE CONNECTION PART BETWEEN THE SUTURE AND THE NEEDLE WAS EASILY DETACHED. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14843604 ↗
• MalfunctionJun 28, 2022Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE CONNECTION PART BETWEEN THE SUTURE AND THE NEEDLE WAS EASILY DETACHED. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14843585 ↗
• MalfunctionJun 24, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND THE SUTURE WAS USED. DURING SURGERY, THE CONNECTION PART BETWEEN THE SUTURE AND THE NEEDLE WAS DETACHED EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14801770 ↗
• MalfunctionJun 24, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND THE SUTURE WAS USED. DURING SURGERY, THE CONNECTION PART BETWEEN THE SUTURE AND THE NEEDLE WAS DETACHED EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14801768 ↗
• MalfunctionJun 24, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND THE SUTURE WAS USED. DURING SURGERY, THE CONNECTION PART BETWEEN THE SUTURE AND THE NEEDLE WAS DETACHED EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14801765 ↗
• MalfunctionJun 24, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND THE SUTURE WAS USED. DURING SURGERY, THE CONNECTION PART BETWEEN THE SUTURE AND THE NEEDLE WAS DETACHED EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14801740 ↗
• MalfunctionJun 24, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND THE SUTURE WAS USED. DURING SURGERY, THE CONNECTION PART BETWEEN THE SUTURE AND THE NEEDLE WAS DETACHED EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14801733 ↗
• MalfunctionJun 24, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND THE SUTURE WAS USED. DURING SURGERY, THE CONNECTION PART BETWEEN THE SUTURE AND THE NEEDLE WAS DETACHED EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14801730 ↗
• MalfunctionDec 15, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SHUNT PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE DURING CONTINUOUS SUTURING. IT WAS NOT A CONTROL RELEASE NEEDLE. IT WAS THE 2ND TIME OF NEEDLE PULL-OFF IN THE SAME BOX. IT WAS REPORTED THAT THIS QUALITY ISSUE HAPPENED WITH ONLY ONE DEVICE DURING THIS PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13011878 ↗

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-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-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-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-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662

…and 6 more.