PROLENE EP8734HRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031206663), received between Jul 12, 2022 and Sep 27, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE MANY TIMES IN A ROW WHEN TYING THE SUTURE. THE SUTURE WAS USED FOR VASCULAR ANASTOMOSIS AND SUTURE METHOD WAS CONTINUOUS SUTURE. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15492316 ↗
• MalfunctionSep 27, 2022Break; Break

  IT WAS REPORTED BY A SALES REP THAT, DURING A SHUNT PLASTY, THE SUTURE BROKE MANY TIMES IN A ROW WHEN TYING THE SUTURE. THE SUTURE WAS USED FOR VASCULAR ANASTOMOSIS AND SUTURE METHOD WAS CONTINUOUS SUTURE. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. WHEN WE SEND THE SAMPLES TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. AFFILIATE REFERENCE NUMBER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15492296 ↗
• MalfunctionSep 27, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE MANY TIMES IN A ROW WHEN TYING THE SUTURE. THE SUTURE WAS USED FOR VASCULAR ANASTOMOSIS AND SUTURE METHOD WAS CONTINUOUS SUTURE. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15492280 ↗
• MalfunctionSep 27, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE MANY TIMES IN A ROW WHEN TYING THE SUTURE. THE SUTURE WAS USED FOR VASCULAR ANASTOMOSIS AND SUTURE METHOD WAS CONTINUOUS SUTURE. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15492239 ↗
• MalfunctionSep 27, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE MANY TIMES IN A ROW WHEN TYING THE SUTURE. THE SUTURE WAS USED FOR VASCULAR ANASTOMOSIS AND SUTURE METHOD WAS CONTINUOUS SUTURE. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15492236 ↗
• MalfunctionJul 12, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE INNER NEEDLE AT BOTH ENDS OF THE PRODUCT DETACHED THE MOMENT THE SURGEON HELD IT. A NEW PACKAGE WAS USED FOR VASCULAR ANASTOMOSIS, AND AFTER CONTINUOUS SUTURING ON LAD, WHEN THE SURGEON WAS ABOUT TO PASS THE NEEDLE-SUTURE TO A SCRUB NURSE, THE NEEDLE DETACHED FROM THE SUTURE AGAIN AND FELL INTO THE PATIENT'S PLEURAL CAVITY. IT TOOK SEVERAL MINUTES TO FIND THE FALLEN NEEDLE AND THERE WAS NO RESIDUE IN THE PATIENT'S BODY. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14991283 ↗
• MalfunctionJul 12, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE INNER NEEDLE AT BOTH ENDS OF THE PRODUCT DETACHED THE MOMENT THE SURGEON HELD IT. A NEW PACKAGE WAS USED FOR VASCULAR ANASTOMOSIS, AND AFTER CONTINUOUS SUTURING ON LAD, WHEN THE SURGEON WAS ABOUT TO PASS THE NEEDLE-SUTURE TO A SCRUB NURSE, THE NEEDLE DETACHED FROM THE SUTURE AGAIN AND FELL INTO THE PATIENT'S PLEURAL CAVITY. IT TOOK SEVERAL MINUTES TO FIND THE FALLEN NEEDLE AND THERE WAS NO RESIDUE IN THE PATIENT'S BODY. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14991029 ↗

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-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• 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-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• 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-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-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844

…and 6 more.