PROLENE EPM8733Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10705031203648), received between Aug 28, 2020 and Sep 25, 2026 — classified as 1 injury, 27 malfunctions.

The most frequently reported specific device problem is “Break” (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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Material Separation

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. The suture detached from the needle. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896252 ↗
• MalfunctionSep 25, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896217 ↗
• MalfunctionAug 19, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50325293 ↗
• MalfunctionAug 19, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50325288 ↗
• MalfunctionAug 19, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50325273 ↗
• MalfunctionAug 19, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50325272 ↗
• MalfunctionFeb 11, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BRIDGE SURGERY ON (B)(6)2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO TIE A KNOT WITH SUTURE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24315568 ↗
• MalfunctionJan 16, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE USING SUTURE TO ANASTOMOSE THE ANTERIOR DESCENDING VESSEL DURING SURGERY, THE SUTURE SUDDENLY BROKE UNDER NORMAL TENSION. THE SURGEON IMMEDIATELY REPLACED THE SAME TYPE OF SUTURE TO COMPLETE THE REMAINING SUTURING, CONFIRMED THAT THE PATIENT'S WOUND HEALING WAS NORMAL, AND RETAINED THE BROKEN SUTURE AND PACKAGING FOR FUTURE REFERENCE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24094179 ↗
• MalfunctionJan 16, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN USING THE SUTURE TO ANASTOMOSE THE DISTAL VESSEL, THE SUTURE STEP MET THE CLINICAL SPECIFICATIONS, THE OPERATOR OPERATED ACCORDING TO THE TECHNIQUE, THERE WAS NO EXCESSIVE TRACTION OR IMPROPER FORCE, AND THE SUTURE SNAPPED WHEN IT DID NOT TOUCH THE SHARP DEVICE. IMMEDIATELY REPLACED THE SAME TYPE OF SUTURE TO COMPLETE THE REMAINING SUTURING, CONFIRMED THAT THE PATIENT'S WOUND HEALING WAS NORMAL, AND RETAINED THE BROKEN SUTURE AND PACKAGING FOR FUTURE REFERENCE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24094178 ↗
• MalfunctionDec 10, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23772287 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MINIMALLY INVASIVE BYPASS SURGERY ON (B)(6)2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303378 ↗
• MalfunctionMay 27, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE, THE SUTURE BROKE WHEN THEY THOUGHT IT SHOULDN'T. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ONE DEVICE WILL BE RETURNED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088141 ↗
• MalfunctionApr 22, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE REP THAT DURING AN CABG PROCEDURE THAT THE NEEDLE DETACHED FROM THE SUTURE. NO FURTHER INFORMATION WAS PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. UNKNOWN NUMBER OF STERILE SAMPLES RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885716 ↗
• MalfunctionMar 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CVT PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE IN OPERATION CVT CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21641163 ↗
• MalfunctionMar 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CVT PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE IN OPERATION CVT CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21641153 ↗
• MalfunctionJan 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS BROKEN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18452002 ↗
• MalfunctionJan 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 11-DEC-2023 AND SUTURE WAS USED. THE SUTURE WAS BROKEN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18451752 ↗
• MalfunctionJan 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE PERFORMING THE ANASTOMOSIS, THE SUTURE SNAPPED THROUGH. THE SURGEON IMMEDIATELY DISCARDED THE DEVICE AND USED A DIFFERENT SUTURE. THE SURGERY WAS NOT DELAYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18450385 ↗
• MalfunctionJan 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 11-DEC-2023 AND SUTURE WAS USED. THE SUTURE WAS BROKEN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18450370 ↗
• MalfunctionJan 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS BROKEN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18450112 ↗
• MalfunctionJan 4, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE SURGERY, THE SUTURE BROKE. THERE WERE NOT PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18442912 ↗
• MalfunctionJan 4, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE SURGERY, THE SUTURE BROKE. THERE WERE NOT PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18442904 ↗
• MalfunctionJun 9, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE POPPED OFF THE SUTURE. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17099921 ↗
• InjuryMar 23, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PEDIATRIC CARDIAC SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE DURING SUTURING. THE BROKEN PART WAS ABOUT 1/3 OF THE NEEDLE. THE BROKEN NEEDLE FELL INTO THE PATIENT'S BODY AND COULD NOT BE FOUND WHEN SEARCHING DIRECTLY. DUE TO THE TIGHT OPERATION TIME, THE SURGERY WAS CONTINUED. AFTER THE COMPLETION OF THE OPERATION ON THE KEY SITE, BEFORE CLOSING THE CHEST, THE BROKEN NEEDLE WAS SEARCHED AGAIN BUT COULD NOT BE FOUND. THE CHEST WAS CLOSED, THE SURGERY WAS COMPLETED AND THE BROKEN NEEDLE REMAINED IN THE PATIENT'S BODY. AFTER SURGERY, THE PATIENT HAD AN X-RAY AND DETERMINED THE BROKEN NEEDLE WAS IN THE BODY. CONSIDERING THAT THE PATIENT HAD JUST FINISHED CARDIAC SURGERY AND WAS STILL UNDER OBSERVATION IN THE INTENSIVE CARE AREA, AND THE BROKEN NEEDLE MAY NOT BE FOUND IF THE CHEST WAS OPENED, THE SURGEON AND THE PATIENT'S FAMILY DECIDED NOT TO PERFORM THE SECOND SURGERY AND REMOVE THE NEEDLE TEMPORARILY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16598300 ↗
• MalfunctionAug 2, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THEY WERE TIED DOWN, AND THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15151746 ↗

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-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• 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-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• 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-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-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879

…and 6 more.