PROLENE EP8735HRecalls & reported problems

Summary

The FDA's MAUDE database contains 128 adverse event reports that list this exact device (DI 10705031206786), received between May 31, 2019 and Sep 30, 2026 — classified as 4 injuries, 124 malfunctions.

The most frequently reported specific device problem is “Material Separation” (95 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 128 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946822 ↗
• InjuryAug 18, 2026Material Integrity Problem; Material Twisted/Bent

  It was reported that a patient underwent a liver transplant surgery on (b)(6) 2026 and suture was used to perform anastomosis on the donor hepatic artery and the recipient right hepatic artery. In an artery, the needle ruptured the artery, the patient began to bleed and they had to open another suture envelope to repair it. The surgeon comments that the needle felt rough and had resistance to passing through the tissue, he also commented that the needle had too much ductility (flexible). The procedure was delayed 20 min. the patient lost 400 to 600 cc of blood. Mechanical proximal and distal control of the bleeding was required during the repair, as well as multiple blood transfusions. Additional information was requested.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Thrombosis/Thrombus

  MAUDE report 50300691 ↗
• MalfunctionJul 8, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25746773 ↗
• MalfunctionMay 29, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE CAME OFF WHILST USING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337236 ↗
• MalfunctionMay 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURES SNAPPED DURING CABG ON DISTAL ANASTOMOSIS OF LIMA. SOME OF IT HAPPENED DURING THE SUTURING AND EVEN HAPPENED WHEN TYING KNOT AFTER ANASTOMOSIS. PROBLEM RESOLVE WHEN OPENED THE 7TH SUTURE FROM A DIFFERENT BATCH NUMBER. DISCOVERED NEEDLE HOLE LEAKAGE DUE TO SUTURING A FEW TIMES ON THE DISTAL ANASTOMOSIS OF LIMA, APPLIED HEMOSTATS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149540 ↗
• MalfunctionMay 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURES SNAPPED DURING CABG ON DISTAL ANASTOMOSIS OF LIMA. SOME OF IT HAPPENED DURING THE SUTURING AND EVEN HAPPENED WHEN TYING KNOT AFTER ANASTOMOSIS. PROBLEM RESOLVE WHEN OPENED THE 7TH SUTURE FROM A DIFFERENT BATCH NUMBER. DISCOVERED NEEDLE HOLE LEAKAGE DUE TO SUTURING A FEW TIMES ON THE DISTAL ANASTOMOSIS OF LIMA, APPLIED HEMOSTATS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149537 ↗
• MalfunctionMay 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURES SNAPPED DURING CABG ON DISTAL ANASTOMOSIS OF LIMA. SOME OF IT HAPPENED DURING THE SUTURING AND EVEN HAPPENED WHEN TYING KNOT AFTER ANASTOMOSIS. PROBLEM RESOLVE WHEN OPENED THE 7TH SUTURE FROM A DIFFERENT BATCH NUMBER. DISCOVERED NEEDLE HOLE LEAKAGE DUE TO SUTURING A FEW TIMES ON THE DISTAL ANASTOMOSIS OF LIMA, APPLIED HEMOSTATS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149535 ↗
• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TAVR PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REPRESENTATIVE THAT DURING A TAVR PROCEDURE, BOTH DEVICES EXPERIENCED BREAKAGE. A DEVICE FROM A DIFFERENT LOT WAS OBTAINED AND USED TO COMPLETE THE PROCEDURE. DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25082584 ↗
• MalfunctionApr 28, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY THE SALES REP THAT THE NEEDLE CAME OUT WITH LITTLE RESISTANCE WHEN A STITCH WAS ABOUT TO BE DONE. WHEN ANOTHER NEEDLE WAS OPENED THEY ALSO POPPED OUT OF THE SUTURE. THERE IS NO ADVERSE IMPACT PATIENT/USER REPORTED. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25019563 ↗
• MalfunctionApr 28, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY THE SALES REP THAT THE NEEDLE CAME OUT WITH LITTLE RESISTANCE WHEN A STITCH WAS ABOUT TO BE DONE. WHEN ANOTHER NEEDLE WAS OPENED THEY ALSO POPPED OUT OF THE SUTURE. THERE IS NO ADVERSE IMPACT PATIENT/USER REPORTED. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25019387 ↗
• MalfunctionApr 14, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. 4 THREADS BROKE FROM THE SAME BOX. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24871939 ↗
• MalfunctionApr 14, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. 4 THREADS BROKE FROM THE SAME BOX. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24871934 ↗
• MalfunctionApr 14, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. 4 THREADS BROKE FROM THE SAME BOX. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24871929 ↗
• MalfunctionApr 7, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANASTOMOSIS PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURE NEEDLE HAS COME LOOSE FROM THE CONNECTION POINT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24798833 ↗
• MalfunctionApr 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING AN UNKNOWN CARDIOVASCULAR SURGERY, THE SUTURE WAS BROKEN WHEN THE TENSION WAS APPLIED. THIS EVENT WAS FOUND BEFORE USE. IT WAS NOT 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 24791843 ↗
• MalfunctionMar 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ANASTOMOSIS PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURE HAS SEPARATED FROM THE NEEDLE INSERTION POINT. THERE HAS BEEN NO ADVERSE EFFECT ON THE PATIENT. THE PROCEDURE HAS CONTINUED WITH A NEW PRODUCT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24664652 ↗
• MalfunctionMar 19, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE LOOSES TOO EASILY, PROBABLY A CRIMPING PROBLEM ON THE LOT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638639 ↗
• MalfunctionFeb 24, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON 28-01-2026 AND SUTURE WAS USED. DURING THE PROCEDURE, NEEDLE GOT DETACHED FROM SWAGE END, DURING ANASTOMOSIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434741 ↗
• MalfunctionFeb 24, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, NEEDLE GOT DETACHED FROM SWAGE END, DURING ANASTOMOSIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434738 ↗
• MalfunctionSep 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT CORONARY ARTERY GRAFTING IN 2025 AND SUTURE WAS USED. DETACHMENT OF THE SUTURE THREAD FROM THE NEEDLE OCCURRED DURING USE ON THE PATIENT. SURGERY WAS CONTINUED BY USING A SUTURE FROM ANOTHER BRAND. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22983715 ↗
• MalfunctionAug 4, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, VICRYL 4/0 RAPIDE VR 2251 LOT AW4035, BREAKS AT THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22704520 ↗
• MalfunctionAug 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C CARDIOVASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, NEEDLE BROKE OFF SUTURE DURING A CARDIAC CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22704171 ↗
• MalfunctionMar 26, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. SUTURE SNAPPED FROM NEEDLE SWAGE. THE NEEDLE DID NOT FALL INTO THE PATIENT AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES. SURGEON CONTINUED WITH SECOND NEEDLE AND COMPLETED THE ANASTOMOSIS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21699900 ↗
• MalfunctionMar 26, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. SUTURE SNAPPED FROM NEEDLE SWAGE. THE NEEDLE DID NOT FALL INTO THE PATIENT AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES. SURGEON CONTINUED WITH SECOND NEEDLE AND COMPLETED THE ANASTOMOSIS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21699893 ↗
• MalfunctionMar 26, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. SUTURE SNAPPED FROM NEEDLE SWAGE. THE NEEDLE DID NOT FALL INTO THE PATIENT AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES. SURGEON CONTINUED WITH SECOND NEEDLE AND COMPLETED THE ANASTOMOSIS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21699889 ↗

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-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• 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-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• 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
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746

…and 6 more.