PROLENE 8557HRecalls & reported problems

Summary

The FDA's MAUDE database contains 109 adverse event reports that list this exact device (DI 10705031017061), received between Aug 19, 2019 and Sep 29, 2026 — classified as 5 injuries, 104 malfunctions.

The most frequently reported specific device problem is “Break” (70 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 109 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Separation

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. The problem of pulling off suture needle happened in surgery. Changed to another one to complete the surgery. No adverse patient consequences were reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933067 ↗
• MalfunctionJul 16, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25849077 ↗
• MalfunctionMay 22, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED WHEN SURGEON USE 8557H, SUTURE KEEPS BREAKING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25254863 ↗
• MalfunctionMay 22, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED WHEN SURGEON USE 8557H, SUTURE KEEPS BREAKING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25254862 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY AHS THAT: "A BARB ON 4-0 PROLENE RB-1 NEEDLE TIP SEEN WITH SURGEONS' LOOPS PRIOR TO USE. " NO OTHER DETAILS PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25097354 ↗
• MalfunctionApr 23, 2026Component Missing; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. INCORRECT QUANTITY-EXTRA NEEDLE & NEEDLE RUST. IT WAS FOUND THAT THERE WAS AN EXTRA NEEDLE WITH RUST ON IT BEFORE USING THE SUTURE, WHICH WAS NOT OPENED FOR USE. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965803 ↗
• MalfunctionApr 7, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THORACOABDOMINAL AORTIC ANEURYSM PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE THORACOABDOMINAL AORTIC ANEURYSM PROCEDURE, THE NEEDLES ARE BENDING AND BREAKING, AND ITS VERY HARD FOR THE SURGEON TO USE. THEY WERE BENDING AND VERY SOFT. THE NEEDLES WERE NOT IN PATIENT'S BODY SOT HERE'S NO PATIENT CONSEQUENCES NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24799356 ↗
• MalfunctionApr 7, 2026Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THORACOABDOMINAL AORTIC ANEURYSM PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE THORACOABDOMINAL AORTIC ANEURYSM PROCEDURE, THE NEEDLES ARE BENDING AND BREAKING, AND ITS VERY HARD FOR THE SURGEON TO USE. THEY WERE BENDING AND VERY SOFT. THE NEEDLES WERE NOT IN PATIENT'S BODY SOT HERE'S NO PATIENT CONSEQUENCES NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24799355 ↗
• MalfunctionFeb 11, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED BY THE SALES REP THAT DURING A VASCULAR PROCEDURE, THEY OPENED THE PRODUCT AND WHEN THEY LOOKED AT THE NEEDLE, IT HAD A FUR IN IT, LIKE IT WAS DEFECTIVE. THEY OPENED ANOTHER ONE AND IT WAS STILL DEFECTIVE. THEY OPENED A NEW BOX AND THE NEEDLES WERE FINE. NONE OF THE DEFECTIVE NEEDLES WERE USED ON THE PATIENTS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24315159 ↗
• InjuryJan 29, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON FOUND THAT THE TIP OF THE NEEDLE HAD BROKEN OFF IN THE HEART. THE TIP OF THE NEEDLE WAS NOT RECOVERED. UNKNOWN IF AN X-RAY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24208316 ↗
• MalfunctionJan 21, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE NEEDLE SWAGE WAS BROKEN DURING USE. NO PIECES WERE LEFT INSIDE THE PATIENT. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. 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 24133160 ↗
• MalfunctionDec 11, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE REPAIR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO SALES REP BY A TECHNICIAN ON THE VASCULAR TEAM AND HANDED REP AN EACH OF UNOPENED PROLENE. THE SUTURE PACKAGE HAS AN UNKNOWN GREY CONTENT INSIDE OF THE PACKAGING - IT APPEARS TO BE PLASTIC REMNANTS. NO PATIENT INVOLVEMENT WAS THERE. ONE DEVICE IS RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23780428 ↗
• MalfunctionNov 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. A CHIEF PHYSICIAN (B)(6), A HIGHLY EXPERIENCED VASCULAR SURGEON, USED OUR SUTURE TO SUTURE AN OPEN AORTA. DURING THE SUTURE, THE NEEDLE BROKE IN THE REINFORCEMENT ZONE. THE NEEDLE WAS RECOVERED. UNFORTUNATELY, NO BATCH NUMBER IS AVAILABLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23572806 ↗
• MalfunctionNov 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP THAT DURING AN UNKNOWN CASE A 4-0 PROLENE ON A RB-1 BROKE OFF. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543683 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE WAS BREAKING TWO TIMES DURING SURGERY WHILE REPAIRING A VESSEL. THEY OPEN ANOTHER LOT NUMBER AND SAME THING HAPPEN. OPENED THE THIRD BOX AND IT WORK FINE. THERE WAS NO PATIENT HARM AND DELAY ON THE CASE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439819 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE WAS BREAKING TWO TIMES DURING SURGERY WHILE REPAIRING A VESSEL. THEY OPEN ANOTHER LOT NUMBER AND SAME THING HAPPEN. OPENED THE THIRD BOX AND IT WORK FINE. THERE WAS NO PATIENT HARM AND DELAY ON THE CASE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439818 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PEDIATRIC HEART SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT DR. SAID 7 OF THE SUTURES BROKE WHILE TRYING TO TIE DURING A PEDIATRIC HEART SURGERY. HE DIDN¿T WANT TO USE ANY MORE FROM THE BOX THOSE 7 WERE PULLED FROM. HE WAS ABLE TO FINISH THE PROCEDURE WITH SUTURE FROM A DIFFERENT BOX. DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23436244 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PEDIATRIC HEART SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT DR. SAID 7 OF THE SUTURES BROKE WHILE TRYING TO TIE DURING A PEDIATRIC HEART SURGERY. HE DIDN'T WANT TO USE ANY MORE FROM THE BOX THOSE 7 WERE PULLED FROM. HE WAS ABLE TO FINISH THE PROCEDURE WITH SUTURE FROM A DIFFERENT BOX. DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23436241 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PEDIATRIC HEART SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT DR. SAID 7 OF THE SUTURES BROKE WHILE TRYING TO TIE DURING A PEDIATRIC HEART SURGERY. HE DIDN¿T WANT TO USE ANY MORE FROM THE BOX THOSE 7 WERE PULLED FROM. HE WAS ABLE TO FINISH THE PROCEDURE WITH SUTURE FROM A DIFFERENT BOX. DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23436233 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PEDIATRIC HEART SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT DR. SAID 7 OF THE SUTURES BROKE WHILE TRYING TO TIE DURING A PEDIATRIC HEART SURGERY. HE DIDN¿T WANT TO USE ANY MORE FROM THE BOX THOSE 7 WERE PULLED FROM. HE WAS ABLE TO FINISH THE PROCEDURE WITH SUTURE FROM A DIFFERENT BOX. DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23436231 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PEDIATRIC HEART SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT DR. SAID 7 OF THE SUTURES BROKE WHILE TRYING TO TIE DURING A PEDIATRIC HEART SURGERY. HE DIDN¿T WANT TO USE ANY MORE FROM THE BOX THOSE 7 WERE PULLED FROM. HE WAS ABLE TO FINISH THE PROCEDURE WITH SUTURE FROM A DIFFERENT BOX. DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23436230 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PEDIATRIC HEART SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT DR. SAID 7 OF THE SUTURES BROKE WHILE TRYING TO TIE DURING A PEDIATRIC HEART SURGERY. HE DIDN¿T WANT TO USE ANY MORE FROM THE BOX THOSE 7 WERE PULLED FROM. HE WAS ABLE TO FINISH THE PROCEDURE WITH SUTURE FROM A DIFFERENT BOX. DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23436213 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PEDIATRIC HEART SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT DR. SAID 7 OF THE SUTURES BROKE WHILE TRYING TO TIE DURING A PEDIATRIC HEART SURGERY. HE DIDN¿T WANT TO USE ANY MORE FROM THE BOX THOSE 7 WERE PULLED FROM. HE WAS ABLE TO FINISH THE PROCEDURE WITH SUTURE FROM A DIFFERENT BOX. DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23436210 ↗
• MalfunctionAug 20, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING CARDIOVASCULAR PROCEDURE THAT THE SUTURE SNAP IN HALF. NO PATIENT HARM WAS REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22852309 ↗
• MalfunctionJul 15, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN VETERINARY CABG PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE REP THAT DURING A CABG PROCEDURE THAT ON AN UNKNOWN NUMBER OF SUTURES THAT THE TIP OF THE NEEDLES WERE BENDING EASILY BUT DID NOT BREAK. ANOTHER LIKE DEVICE WAS USED TILL THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO DEVICES RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22514074 ↗

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-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• 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-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981

…and 6 more.