PROLENE 8206HRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031013322), received between Oct 10, 2019 and Sep 3, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE SURGEON EXPERIENCED A NEEDLE BREAKING OFF FROM THE SUTURE DURING A VASCULAR PROCEDURE. HE WAS SEWING IN A GRAFT AS A BYPASS FOR THE FEMORAL ARTERY. HE WAS USING ITEM # 8206 WHEN THE NEEDLE DISENGAGED FROM THE SUTURE ABOUT 1/4 OF THE WAY OF THE ANASTAMOSIS. HE HAD MADE APPROXIMATELY 3-4 PASSES WITH THAT SUTURE, SO IT WAS HOLDING INITIALLY. HE DIDN¿T INCREASE THE FORCE WITH WHICH HE WAS PULLING THE SUTURE THROUGH, BUT IT JUST POPPED OFF. HE THEN COMPLETED THE ANASTAMOSIS WITH THE NEEDLE ON THE OTHER END OF THAT SUTURE STRAND WITH NO PROBLEM. THERE WASN¿T ANY DELAY OR NEGATIVE PATIENT OUTCOME, BUT THE SURGEON WAS FRUSTRATED AND IF IT HAD HAPPENED TO THE 2ND NEEDLE THEN THERE COULD BE BAD CONSEQUENCES FOR THE PATIENT. HE THEN TOLD THAT THIS HAD HAPPENED BEFORE WITH THE SAME SUTURE. WHEN THE REP ASKED IF HE COULD GIVE DETAILS TO REPORT IT HAPPENING BEFORE HE SAID HE COULDN¿T AND WOULD NOT SHARE ANY ADDITIONAL INFORMATION OTHER THAN THE GENERAL CLAIM THAT IT HAS HAPPENED BEFORE. THE REP REITERATED WITH HIM THAT NEED TO BE MADE AWA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22957414 ↗
• MalfunctionAug 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE SURGEON EXPERIENCED A NEEDLE BREAKING OFF FROM THE SUTURE DURING A VASCULAR PROCEDURE. HE WAS SEWING IN A GRAFT AS A BYPASS FOR THE FEMORAL ARTERY. HE WAS USING ITEM # 8206 WHEN THE NEEDLE DISENGAGED FROM THE SUTURE ABOUT 1/4 OF THE WAY OF THE ANASTAMOSIS. HE HAD MADE APPROXIMATELY 3-4 PASSES WITH THAT SUTURE, SO IT WAS HOLDING INITIALLY. HE DIDN¿T INCREASE THE FORCE WITH WHICH HE WAS PULLING THE SUTURE THROUGH, BUT IT JUST POPPED OFF. HE THEN COMPLETED THE ANASTAMOSIS WITH THE NEEDLE ON THE OTHER END OF THAT SUTURE STRAND WITH NO PROBLEM. THERE WASN¿T ANY DELAY OR NEGATIVE PATIENT OUTCOME, BUT THE SURGEON WAS FRUSTRATED AND IF IT HAD HAPPENED TO THE 2ND NEEDLE THEN THERE COULD BE BAD CONSEQUENCES FOR THE PATIENT. HE THEN TOLD THAT THIS HAD HAPPENED BEFORE WITH THE SAME SUTURE. WHEN THE REP ASKED IF HE COULD GIVE DETAILS TO REPORT IT HAPPENING BEFORE HE SAID HE COULDN¿T AND WOULD NOT SHARE ANY ADDITIONAL INFORMATION OTHER THAN THE GENERAL CLAIM THAT IT HAS HAPPENED BEFORE. THE REP REITERATED WITH HIM THAT NEED TO BE MADE AWARE OF A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22923686 ↗
• MalfunctionAug 26, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE SURGEON THAT THE NEEDLE POPPED OFF WHILE SUTURING DURING A CARDIAC SURGERY (PULLING THE EXTRA SUTURE TAUGHT ON A RUNNING STITCH). THE CASE CONTINUED AND THE SUTURE WAS SWAPPED OUT WITH THE SAME SUTURE OF A DIFFERENT LOT NUMBER. THE PATIENT WAS NOT HARMED. IT HAPPENED ON 2 PACKS IN A ROW. ONE OF THE NEEDLES FLEW TO THE END OF THE STERILE FIELD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. DEVICES WERE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893657 ↗
• MalfunctionAug 26, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE SURGEON THAT THE NEEDLE POPPED OFF WHILE SUTURING DURING A CARDIAC SURGERY (PULLING THE EXTRA SUTURE TAUGHT ON A RUNNING STITCH). THE CASE CONTINUED AND THE SUTURE WAS SWAPPED OUT WITH THE SAME SUTURE OF A DIFFERENT LOT NUMBER. THE PATIENT WAS NOT HARMED. IT HAPPENED ON 2 PACKS IN A ROW. ONE OF THE NEEDLES FLEW TO THE END OF THE STERILE FIELD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. DEVICES WERE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893560 ↗
• MalfunctionJan 28, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON WAS USING THE SUTURE ON AN RB3, THE NEEDLE DISENGAGED PREMATURELY FROM THE SUTURE. THE SURGEON WAS DOING AN ANASTOMOSIS WITH THE SUTURE AND THE NEEDLE POPPED OFF BEFORE IT NEEDED TO POP OFF. THE CASE WAS COMPLETED WITH A LIKE DEVICE. THE SURGERY WAS DELAYED BY TWO MINUTES DUE TO THE REPORTED EVENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21258027 ↗
• MalfunctionNov 22, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. SURGEON HAS EXPERIENCED PREMATURE NEEDLE DISENGAGEMENT FROM THE SUTURE. HE EXPLAINED THAT IT CAUSES A SEVERAL MINUTE DELAY EACH TIME IT HAPPENS BECAUSE HE HAS TO START OVER ON THE VESSEL ANASTOMOSIS. THE PROCEDURE WAS DELAYED BY FOUR MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. DEVICES WERE RETURNING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20764729 ↗
• MalfunctionNov 22, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. SURGEON HAS EXPERIENCED PREMATURE NEEDLE DISENGAGEMENT FROM THE SUTURE. HE EXPLAINED THAT IT CAUSES A SEVERAL MINUTE DELAY EACH TIME IT HAPPENS BECAUSE HE HAS TO START OVER ON THE VESSEL ANASTOMOSIS. THE PROCEDURE WAS DELAYED BY FOUR MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. DEVICES WERE RETURNING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20762059 ↗
• InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AUTOLOGOUS SUBCUTANEOUS ARTERIOVENOUS FISTULA CREATION FOR HEMODIALYSIS ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS RECOGNIZED THAT THERE WAS A LEAK FROM THE ARTERIOVENOUS FISTULA CREATED BY SIDE-TO-SIDE ANASTOMOSIS WITH THE SUTURE. THE SURGEON SUTURED AGAIN WITH ANOTHER SUTURE. THE OPERATION WAS TERMINATED WITH PLACEMENT OF A PENROSE DRAIN. IMMEDIATELY AFTER THE PROCEDURE, NO PAIN WAS RECOGNIZED. THE DRAIN WAS REMOVED 2 DAYS AFTER THE OPERATION. AFTERWARDS, A SEROMA WAS RECOGNIZED AT 13 DAYS AFTER THE OPERATION, BUT ASPIRATION OR RESECTION WAS NOT PERFORMED BECAUSE IT WAS NOT RECOGNIZED THAT A SEROMA FLARED A RESULT OF ULTRASONOGRAPHY. SHE WAS DISCHARGED ON THE 27TH DAY OF THE OPERATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose

  MAUDE report 19477569 ↗
• MalfunctionMay 31, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE UNKNOWN SURGERY, AFTER TAKING THE SUTURE OUT OF PACKAGE, THE SUTURE WAS EASILY BROKEN DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17032488 ↗
• MalfunctionJun 23, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE "BURST" WHILE PULLING IT TOGETHER AND TIGHTENING IT DOWN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10183624 ↗
• MalfunctionOct 10, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BYPASS SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WITH ONLY MINIMAL TENSION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9177069 ↗

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-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• 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-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• 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-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-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• 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-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988

…and 6 more.