PROLENE EPM8735Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 10705031203662), received between Aug 27, 2019 and Apr 3, 2026 — classified as 1 death, 50 malfunctions.

The most frequently reported specific device problem is “Material Separation” (37 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 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT PROCEDURE ON AN UNKNOWN DATE SUTURE WAS USED. DURING THE PROCEDURE, THE BOX OF SUTURE WAS FAULTY, IT KEPT FALLING APART WHICH MEANS THE SUTURE WAS JUST BREAKING WITH ALMOST NO TENSION APPLIED TO THAT SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24778408 ↗
• MalfunctionNov 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP BY THE SURGEON WHO WAS USING THE SUTURE AND NOTICED THAT THE NEEDLES WERE POPPING OFF EASIER THAN THEY SHOULD OR TYPICALLY DO, CREATING A BIT MORE CONCERN AND ATTENTION TO FOCUSING ON NOT LOSING ANY NEEDLES. THE TECH ALSO MENTIONED THIS PARTICULAR PACK HAD MORE PACKAGE MEMORY DESPITE BEING A PROLENE LONG PACK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23485917 ↗
• MalfunctionNov 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP BY THE SURGEON WHO WAS USING THE SUTURE AND NOTICED THAT THE NEEDLES WERE POPPING OFF EASIER THAN THEY SHOULD OR TYPICALLY DO, CREATING A BIT MORE CONCERN AND ATTENTION TO FOCUSING ON NOT LOSING ANY NEEDLES. THE TECH ALSO MENTIONED THIS PARTICULAR PACK HAD MORE PACKAGE MEMORY DESPITE BEING A PROLENE LONG PACK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23485916 ↗
• MalfunctionOct 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THE SURGEON WHO WAS DOING AN IN-SERVICE YESTERDAY IN THE BREAK ROOM AT THE HOSPITAL. IT WAS APPROACHED BY A NURSE, WHO EXPRESSED HER FRUSTRATION ABOUT NEEDLES BEING HARD TO SEE AND GETTING DROPPED. SHE WAS WONDERING IF I HAD ANY IDEAS ON HOW TO STORE THESE NEEDLES WHEN NOT IN USE DURING CASES. THE REP TOLD HER TO CUT THE SUTURE TAIL LONGER, SO THE DYED SUTURE AND NEEDLE ARE VISIBLE, MAKING IT EASIER TO SEE AND ALSO SUGGESTED A NEEDLE BOOT TO HOLD THE NEEDLE. SHE MENTIONED DURING A CABG PROCEDURE THAT DAY THAT THE EVERPOINT NEEDLE WAS DROPPED. SURGERY WAS PAUSED AND FINALLY AFTER SOME TIME LOOKING FOR THE SUTURE, THEY CALLED X-RAY. SHE SAID X-RAY SHOWED NO SIGNS OF NEEDLE. SURGERY RESUMED AND NEEDLE WAS NEVER FOUND. THE REP WAS ASKED HOW MANY TIMES THE NEEDLE HAS BEEN DROPPED IN CASES. SHE SAID AT LEAST FIVE OR SIX TIMES IN THE LAST COUPLE MONTHS. THE SURGEON TOLD HER THAT WOULD REPORT THIS EVENT THROUGH OUR HOTLINE AND FOLLOW UP WITH HER. THE PROCEDURE WAS DELAYED BY SIXTY MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. AD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23311563 ↗
• MalfunctionOct 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THE SURGEON WHO WAS DOING AN IN-SERVICE YESTERDAY IN THE BREAK ROOM AT THE HOSPITAL. IT WAS APPROACHED BY A NURSE, WHO EXPRESSED HER FRUSTRATION ABOUT NEEDLES BEING HARD TO SEE AND GETTING DROPPED. SHE WAS WONDERING IF I HAD ANY IDEAS ON HOW TO STORE THESE NEEDLES WHEN NOT IN USE DURING CASES. THE REP TOLD HER TO CUT THE SUTURE TAIL LONGER, SO THE DYED SUTURE AND NEEDLE ARE VISIBLE, MAKING IT EASIER TO SEE AND ALSO SUGGESTED A NEEDLE BOOT TO HOLD THE NEEDLE. SHE MENTIONED DURING A CABG PROCEDURE THAT DAY THAT THE EVERPOINT NEEDLE WAS DROPPED. SURGERY WAS PAUSED AND FINALLY AFTER SOME TIME LOOKING FOR THE SUTURE, THEY CALLED X-RAY. SHE SAID X-RAY SHOWED NO SIGNS OF NEEDLE. SURGERY RESUMED AND NEEDLE WAS NEVER FOUND. THE REP WAS ASKED HOW MANY TIMES THE NEEDLE HAS BEEN DROPPED IN CASES. SHE SAID AT LEAST FIVE OR SIX TIMES IN THE LAST COUPLE MONTHS. THE SURGEON TOLD HER THAT WOULD REPORT THIS EVENT THROUGH OUR HOTLINE AND FOLLOW UP WITH HER. THE PROCEDURE WAS DELAYED BY SIXTY MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. AD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23311548 ↗
• MalfunctionOct 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THE SURGEON WHO WAS DOING AN IN-SERVICE YESTERDAY IN THE BREAK ROOM AT THE HOSPITAL. IT WAS APPROACHED BY A NURSE, WHO EXPRESSED HER FRUSTRATION ABOUT NEEDLES BEING HARD TO SEE AND GETTING DROPPED. SHE WAS WONDERING IF I HAD ANY IDEAS ON HOW TO STORE THESE NEEDLES WHEN NOT IN USE DURING CASES. THE REP TOLD HER TO CUT THE SUTURE TAIL LONGER, SO THE DYED SUTURE AND NEEDLE ARE VISIBLE, MAKING IT EASIER TO SEE AND ALSO SUGGESTED A NEEDLE BOOT TO HOLD THE NEEDLE. SHE MENTIONED DURING A CABG PROCEDURE THAT DAY THAT THE EVERPOINT NEEDLE WAS DROPPED. SURGERY WAS PAUSED AND FINALLY AFTER SOME TIME LOOKING FOR THE SUTURE, THEY CALLED X-RAY. SHE SAID X-RAY SHOWED NO SIGNS OF NEEDLE. SURGERY RESUMED AND NEEDLE WAS NEVER FOUND. THE REP WAS ASKED HOW MANY TIMES THE NEEDLE HAS BEEN DROPPED IN CASES. SHE SAID AT LEAST FIVE OR SIX TIMES IN THE LAST COUPLE MONTHS. THE SURGEON TOLD HER THAT WOULD REPORT THIS EVENT THROUGH OUR HOTLINE AND FOLLOW UP WITH HER. THE PROCEDURE WAS DELAYED BY SIXTY MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. AD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23311536 ↗
• MalfunctionOct 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THE SURGEON WHO WAS DOING AN IN-SERVICE YESTERDAY IN THE BREAK ROOM AT THE HOSPITAL. IT WAS APPROACHED BY A NURSE, WHO EXPRESSED HER FRUSTRATION ABOUT NEEDLES BEING HARD TO SEE AND GETTING DROPPED. SHE WAS WONDERING IF I HAD ANY IDEAS ON HOW TO STORE THESE NEEDLES WHEN NOT IN USE DURING CASES. THE REP TOLD HER TO CUT THE SUTURE TAIL LONGER, SO THE DYED SUTURE AND NEEDLE ARE VISIBLE, MAKING IT EASIER TO SEE AND ALSO SUGGESTED A NEEDLE BOOT TO HOLD THE NEEDLE. SHE MENTIONED DURING A CABG PROCEDURE THAT DAY THAT THE EVERPOINT NEEDLE WAS DROPPED. SURGERY WAS PAUSED AND FINALLY AFTER SOME TIME LOOKING FOR THE SUTURE, THEY CALLED X-RAY. SHE SAID X-RAY SHOWED NO SIGNS OF NEEDLE. SURGERY RESUMED AND NEEDLE WAS NEVER FOUND. THE REP WAS ASKED HOW MANY TIMES THE NEEDLE HAS BEEN DROPPED IN CASES. SHE SAID AT LEAST FIVE OR SIX TIMES IN THE LAST COUPLE MONTHS. THE SURGEON TOLD HER THAT WOULD REPORT THIS EVENT THROUGH OUR HOTLINE AND FOLLOW UP WITH HER. THE PROCEDURE WAS DELAYED BY SIXTY MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. AD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23311511 ↗
• MalfunctionOct 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THE SURGEON WHO WAS DOING AN IN-SERVICE YESTERDAY IN THE BREAK ROOM AT THE HOSPITAL. IT WAS APPROACHED BY A NURSE, WHO EXPRESSED HER FRUSTRATION ABOUT NEEDLES BEING HARD TO SEE AND GETTING DROPPED. SHE WAS WONDERING IF I HAD ANY IDEAS ON HOW TO STORE THESE NEEDLES WHEN NOT IN USE DURING CASES. THE REP TOLD HER TO CUT THE SUTURE TAIL LONGER, SO THE DYED SUTURE AND NEEDLE ARE VISIBLE, MAKING IT EASIER TO SEE AND ALSO SUGGESTED A NEEDLE BOOT TO HOLD THE NEEDLE. SHE MENTIONED DURING A CABG PROCEDURE THAT DAY THAT THE EVERPOINT NEEDLE WAS DROPPED. SURGERY WAS PAUSED AND FINALLY AFTER SOME TIME LOOKING FOR THE SUTURE, THEY CALLED X-RAY. SHE SAID X-RAY SHOWED NO SIGNS OF NEEDLE. SURGERY RESUMED AND NEEDLE WAS NEVER FOUND. THE REP WAS ASKED HOW MANY TIMES THE NEEDLE HAS BEEN DROPPED IN CASES. SHE SAID AT LEAST FIVE OR SIX TIMES IN THE LAST COUPLE MONTHS. THE SURGEON TOLD HER THAT WOULD REPORT THIS EVENT THROUGH OUR HOTLINE AND FOLLOW UP WITH HER. THE PROCEDURE WAS DELAYED BY SIXTY MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. AD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23311486 ↗
• MalfunctionOct 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THE SURGEON WHO WAS DOING AN IN-SERVICE YESTERDAY IN THE BREAK ROOM AT THE HOSPITAL. IT WAS APPROACHED BY A NURSE, WHO EXPRESSED HER FRUSTRATION ABOUT NEEDLES BEING HARD TO SEE AND GETTING DROPPED. SHE WAS WONDERING IF I HAD ANY IDEAS ON HOW TO STORE THESE NEEDLES WHEN NOT IN USE DURING CASES. THE REP TOLD HER TO CUT THE SUTURE TAIL LONGER, SO THE DYED SUTURE AND NEEDLE ARE VISIBLE, MAKING IT EASIER TO SEE AND ALSO SUGGESTED A NEEDLE BOOT TO HOLD THE NEEDLE. SHE MENTIONED DURING A CABG PROCEDURE THAT DAY THAT THE EVERPOINT NEEDLE WAS DROPPED. SURGERY WAS PAUSED AND FINALLY AFTER SOME TIME LOOKING FOR THE SUTURE, THEY CALLED X-RAY. SHE SAID X-RAY SHOWED NO SIGNS OF NEEDLE. SURGERY RESUMED AND NEEDLE WAS NEVER FOUND. THE REP WAS ASKED HOW MANY TIMES THE NEEDLE HAS BEEN DROPPED IN CASES. SHE SAID AT LEAST FIVE OR SIX TIMES IN THE LAST COUPLE MONTHS. THE SURGEON TOLD HER THAT WOULD REPORT THIS EVENT THROUGH OUR HOTLINE AND FOLLOW UP WITH HER. THE PROCEDURE WAS DELAYED BY SIXTY MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23311398 ↗
• MalfunctionJul 23, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY SALES REP PER ACCOUNT THAT BOTH LOTS HAVING THE SAME ISSUE. BREAKING WHEN TYING KNOTS AND DETACHING FROM THE NEEDLE. NO ADVERSE IMPACT PATIENT/USER WAS REPORTED. DEVICES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22577072 ↗
• MalfunctionJul 23, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY SALES REP PER ACCOUNT THAT BOTH LOTS HAVING THE SAME ISSUE. BREAKING WHEN TYING KNOTS AND DETACHING FROM THE NEEDLE. NO ADVERSE IMPACT PATIENT/USER WAS REPORTED. DEVICES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576841 ↗
• MalfunctionJul 23, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY SALES REP PER ACCOUNT THAT BOTH LOTS HAVING THE SAME ISSUE. BREAKING WHEN TYING KNOTS AND DETACHING FROM THE NEEDLE. NO ADVERSE IMPACT PATIENT/USER WAS REPORTED. DEVICES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576820 ↗
• MalfunctionJun 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY SALES REP PER ACCOUNT THAT THE NEEDLE POPS OFF WHILE THEY'RE USING IT AND IT'S NOT SUPPOSED TO. SAME EXACT ISSUE HAPPENED FOR TWO DOCTORS. NO ADVERSE IMPACT PATIENT/USER WAS REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329847 ↗
• MalfunctionJun 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY SALES REP PER ACCOUNT THAT THE NEEDLE POPS OFF WHILE THEY'RE USING IT AND IT'S NOT SUPPOSED TO. SAME EXACT ISSUE HAPPENED FOR TWO DOCTORS. NO ADVERSE IMPACT PATIENT/USER WAS REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329842 ↗
• MalfunctionJun 13, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY THE SALES REP THAT THE NEEDLES WERE POPPING OFF AND HE HAD TO GET A NEW NEEDLE EVER TIME. EVERY OTHER ONE WAS POPPING OFF. THEY HAVE ABOUT 5 MORE BOXES WITH THE SAME LOT NUMBER. 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 22203916 ↗
• MalfunctionJun 13, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY THE SALES REP THAT THE NEEDLES WERE POPPING OFF AND HE HAD TO GET A NEW NEEDLE EVER TIME. EVERY OTHER ONE WAS POPPING OFF. THEY HAVE ABOUT 5 MORE BOXES WITH THE SAME LOT NUMBER. 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 22203912 ↗
• MalfunctionApr 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THIS IS AN ONGOING ISSUE WITH THE MULTI PACKS. THE NEEDLE IS POPPING OFF WHILE SEWING UP A HEART DURING A CABG. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860105 ↗
• MalfunctionFeb 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE SURGEON WAS USING A NON EVERPOINT NEEDLE AND THAT ONE DULLED. A COUPLE MONTHS AGO HE SWITCHED TO THE EVERPOINT. DURING A CABG HE TOLD THE REP THAT THE NEEDLE KEPT POPPING OFF AND THE SURGEON WAS APPLYING TO MUCH FORCE AND SWITCHED BACK TO THE OTHER PRODUCT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21437725 ↗
• MalfunctionFeb 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE SURGEON WAS USING A NON EVERPOINT NEEDLE AND THAT ONE DULLED. A COUPLE MONTHS AGO HE SWITCHED TO THE EVERPOINT. DURING A CABG HE TOLD THE REP THAT THE NEEDLE KEPT POPPING OFF AND THE SURGEON WAS APPLYING TO MUCH FORCE AND SWITCHED BACK TO THE OTHER PRODUCT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21437565 ↗
• MalfunctionOct 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED FROM THE SURGEON THAT THE SUTURE HAD MORE MEMORY THAN WHAT HE WAS USED TO, AND THE NEEDLES APPEARED TO POP OFF MUCH EASIER THAN THE NORM. NEEDLES WERE RETRIEVED AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20515525 ↗
• MalfunctionSep 30, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SURGEON THAT THE NEEDLES WERE BREAKING OF THE SWEDGE WITH NO PRESSURE APPLIED AND THEY WERE HANDED TO HIM CORRECTLY. THEY WERE ABLE TO RETRIEVE THE NEEDLES AND COMPLETED THE CASE WITH ANOTHER ONE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20339440 ↗
• MalfunctionSep 30, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SURGEON THAT THE NEEDLES WERE BREAKING OF THE SWEDGE WITH NO PRESSURE APPLIED AND THEY WERE HANDED TO HIM CORRECTLY. THEY WERE ABLE TO RETRIEVE THE NEEDLES AND COMPLETED THE CASE WITH ANOTHER ONE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20337391 ↗
• MalfunctionSep 27, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE FROM THE SWAGE WITH NO PRESSURE APPLIED AND IT WAS HANDED TO HIM CORRECTLY. THEY WERE ABLE TO RETRIEVE THE NEEDLE AND COMPLETED THE CASE WITH ANOTHER ONE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20320711 ↗
• MalfunctionSep 27, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE FROM THE SWAGE WITH NO PRESSURE APPLIED AND IT WAS HANDED TO HIM CORRECTLY. THEY WERE ABLE TO RETRIEVE THE NEEDLE AND COMPLETED THE CASE WITH ANOTHER ONE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20320691 ↗
• MalfunctionSep 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS POPPED OFF. THE CASE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20206757 ↗

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-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-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-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988

…and 6 more.