PROLENE EP8711HRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705031231313), received between May 7, 2019 and Aug 25, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50435802 ↗
• MalfunctionAug 25, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50435797 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, SURGEON USING EP8711H, SUTURES REPEATEDLY SNAPPING, NURSE OPENED A FEW BEFORE DETERMINING IT MUST BE THE LOT. THEY DISCARDED THE AFFECTED BOXES. THEY HAD BOXES OF ANOTHER LOT NUMBER SO THEY COULD CONTINUE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24817688 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, SURGEON USING EP8711H, SUTURES REPEATEDLY SNAPPING, NURSE OPENED A FEW EACHES BEFORE DETERMINING IT MUST BE THE LOT. THEY DISCARDED THE AFFECTED BOXES. THEY HAD BOXES OF ANOTHER LOT NUMBER SO THEY COULD CONTINUE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24817657 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, SURGEON USING EP8711H, SUTURES REPEATEDLY SNAPPING, NURSE OPENED A FEW OF EACH BEFORE DETERMINING IT MUST BE THE LOT. THEY DISCARDED THE AFFECTED BOXES. THEY HAD BOXES OF ANOTHER LOT NUMBER SO THEY COULD CONTINUE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24817655 ↗
• MalfunctionApr 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING A CORONARY ARTERY BYPASS GRAFTING, THE SUTURE ON BOTH SIDES WERE BROKEN DURING CONTINUOUS SUTURING WHEN ANASTOMOSING THE FREE GRAFT TO A MAJOR BLOOD VESSEL. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT OF A DIFFERENT LOT WAS USED BUT THE SUTURE ON ONE NEEDLE SIDE WAS BROKEN DURING CONTINUOUS SUTURING. THE ANASTOMOSIS WAS COMPLETED TO THE CASE BY USING THE OTHER NEEDLE SIDE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793701 ↗
• MalfunctionApr 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING A CORONARY ARTERY BYPASS GRAFTING, THE SUTURE ON BOTH SIDES WERE BROKEN DURING CONTINUOUS SUTURING WHEN ANASTOMOSING THE FREE GRAFT TO A MAJOR BLOOD VESSEL. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT OF A DIFFERENT LOT WAS USED BUT THE SUTURE ON ONE NEEDLE SIDE WAS BROKEN DURING CONTINUOUS SUTURING. THE ANASTOMOSIS WAS COMPLETED TO THE CASE BY USING THE OTHER NEEDLE SIDE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793699 ↗
• MalfunctionMar 26, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OPEN CARDIOVASCULAR SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN IMMEDIATELY EVEN THOUGH IT WAS USED WITH A WEAK TENSION DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21697367 ↗
• MalfunctionDec 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. WE RECEIVED A REQUEST TO INVESTIGATE 5 PRODUCTS IN THIS LOT, AS THEY WERE WRONG IN A ROW. THE FIVE USED PRODUCTS WERE DISCARDED. WE ASKED THE NURSE IN CHARGE, SPD, AND THE DISTRIBUTOR TO MAKE SURE TO KEEP THE PRODUCT THE NEXT TIME WHEN THEY FELT SOMETHING WAS WRONG. THEY ARE USING WITH DIFFERENT LOTS OF PRODUCTS NOW. 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 20905752 ↗
• MalfunctionDec 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR PROCEDURE ON 12/3/2024 AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. WE RECEIVED A REQUEST TO INVESTIGATE 5 PRODUCTS IN THIS LOT, AS THEY WERE WRONG IN A ROW. THE FIVE USED PRODUCTS WERE DISCARDED. WE ASKED THE NURSE IN CHARGE, SPD, AND THE DISTRIBUTOR TO MAKE SURE TO KEEP THE PRODUCT THE NEXT TIME WHEN THEY FELT SOMETHING WAS WRONG. THEY ARE USING WITH DIFFERENT LOTS OF PRODUCTS NOW. 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 20905721 ↗
• MalfunctionDec 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. WE RECEIVED A REQUEST TO INVESTIGATE 5 PRODUCTS IN THIS LOT, AS THEY WERE WRONG IN A ROW. THE FIVE USED PRODUCTS WERE DISCARDED. WE ASKED THE NURSE IN CHARGE, SPD, AND THE DISTRIBUTOR TO MAKE SURE TO KEEP THE PRODUCT THE NEXT TIME WHEN THEY FELT SOMETHING WAS WRONG. THEY ARE USING WITH DIFFERENT LOTS OF PRODUCTS NOW. 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 20905484 ↗
• MalfunctionDec 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. WE RECEIVED A REQUEST TO INVESTIGATE 5 PRODUCTS IN THIS LOT, AS THEY WERE WRONG IN A ROW. THE FIVE USED PRODUCTS WERE DISCARDED. WE ASKED THE NURSE IN CHARGE, SPD, AND THE DISTRIBUTOR TO MAKE SURE TO KEEP THE PRODUCT THE NEXT TIME WHEN THEY FELT SOMETHING WAS WRONG. THEY ARE USING WITH DIFFERENT LOTS OF PRODUCTS NOW. 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 20905425 ↗
• MalfunctionDec 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. WE RECEIVED A REQUEST TO INVESTIGATE 5 PRODUCTS IN THIS LOT, AS THEY WERE WRONG IN A ROW. THE FIVE USED PRODUCTS WERE DISCARDED. WE ASKED THE NURSE IN CHARGE, SPD, AND THE DISTRIBUTOR TO MAKE SURE TO KEEP THE PRODUCT THE NEXT TIME WHEN THEY FELT SOMETHING WAS WRONG. THEY ARE USING WITH DIFFERENT LOTS OF PRODUCTS NOW. 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 20905253 ↗
• MalfunctionFeb 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED FROM THE CUSTOMER THAT THE NEEDLE WAS COMING OFF WITH THE EVERPOINT SUTURE WITHOUT MUCH TENSION BEING DONE WHEN AFTER A FEW PASSES THROUGH TISSUE ON THE DISTAL ANASTOMOSIS INVOLVED WITH LOT NUMBER THBEQJ. SURGEON WANTS TO SEND BACK IMPACTED LOT IN EXCHANGE FOR ANOTHER ONE. REP ONLY HAS SAMPLES TO RETURN BUT NOT THE ACTUAL IMPACTED PRODUCT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18676879 ↗
• MalfunctionApr 30, 2021Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. IT WAS NOTED PRIOR TO USE THAT THE NEEDLE WAS "BURRED¿. NO FRAGMENTS WERE GENERATED AND THERE WAS NO DELAY IN SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO PATIENT CONSEQUENCES., HE SPOTTED BEFORE USING IT. NO FURTHER EVENT INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11752615 ↗
• MalfunctionApr 29, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE SEPARATED FROM THE SUTURE MID PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10011389 ↗
• MalfunctionMay 7, 2019Break; Break

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8587059 ↗

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-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292

…and 6 more.