PROLENE 8556HRecalls & reported problems

Summary

The FDA's MAUDE database contains 240 adverse event reports that list this exact device (DI 10705031017030), received between Jan 18, 2019 and May 27, 2026 — classified as 1 death, 7 injuries, 232 malfunctions.

The most frequently reported specific device problem is “Break” (139 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 240 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURES WITH THIS LOT WERE BROKEN FREQUENTLY DURING SURGERY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED 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 25301073 ↗
• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURES WITH THIS LOT WERE BROKEN FREQUENTLY DURING SURGERY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED 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 25300188 ↗
• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURES WITH THIS LOT WERE BROKEN FREQUENTLY DURING SURGERY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED 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 25300186 ↗
• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURES WITH THIS LOT WERE BROKEN FREQUENTLY DURING SURGERY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED 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 25300170 ↗
• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURES WITH THIS LOT WERE BROKEN FREQUENTLY DURING SURGERY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED 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 25300150 ↗
• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURES WITH THIS LOT WERE BROKEN FREQUENTLY DURING SURGERY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED 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 25300131 ↗
• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURES WITH THIS LOT WERE BROKEN FREQUENTLY DURING SURGERY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED 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 25300130 ↗
• MalfunctionFeb 25, 2026Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. WHEN THE PRODUCT WAS OPENED, IT WAS FOUND BEFORE USE THAT THE SUTURE HAD BEEN BROKEN ALREADY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24441820 ↗
• MalfunctionFeb 2, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIAC SURGEON ON (B)(6) 2026 AN SUTURE WAS USED. CARDIAC SURGEON EXPERIENCED NEEDLES COMING OFF OF THE SUTURE AFTER PASSING THE SUTURE THROUGH THE TISSUE ON AN AORTIC VALVE REPAIR. THEY SAVED THE BOX FROM THE LOT # THAT WAS USED. THIS HAPPENED WITH MULTIPLE SUTURES DURING THE PROCEDURE. SURGICAL TEAM AND SURGEON ARE VERY FRUSTRATED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WERE NO SIGNIFICANT DELAYS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24234819 ↗
• MalfunctionFeb 2, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIAC SURGEON ON (B)(6) 2026 AN SUTURE WAS USED. CARDIAC SURGEON EXPERIENCED NEEDLES COMING OFF OF THE SUTURE AFTER PASSING THE SUTURE THROUGH THE TISSUE ON AN AORTIC VALVE REPAIR. THEY SAVED THE BOX FROM THE LOT # THAT WAS USED. THIS HAPPENED WITH MULTIPLE SUTURES DURING THE PROCEDURE. SURGICAL TEAM AND SURGEON ARE VERY FRUSTRATED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WERE NO SIGNIFICANT DELAYS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24234494 ↗
• MalfunctionJan 8, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN CARDIOVASCULAR SURGERY, THE TWO SUTURES WERE BROKEN. IT WAS THE SAME EVENT AS (B)(4). (THERE WAS A LITTLE MORE RESISTANCE THAN LAST TIME.) THE USE OF THE SAME LOT WAS STOPPED, AND THE SURGERY WAS COMPLETED WITH A DIFFERENT LOT. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED 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 24009813 ↗
• MalfunctionJan 8, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN CARDIOVASCULAR SURGERY, THE TWO SUTURES WERE BROKEN. IT WAS THE SAME EVENT AS (B)(4). (THERE WAS A LITTLE MORE RESISTANCE THAN LAST TIME.) THE USE OF THE SAME LOT WAS STOPPED, AND THE SURGERY WAS COMPLETED WITH A DIFFERENT LOT. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED 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 24009795 ↗
• InjuryDec 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE REPAIR ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON MADE CONTINUED KNOTTING AND ULTRASONIC DETECTION SHOWED NO PROBLEM BEFORE CLOSING THE CHEST. A FEW DAYS AFTER THE PROCEDURE, REGURGITATION WAS DETECTED. THE PATIENT UNDERWENT A FIRST THORACOTOMY. DURING THE PROCEDURE, THE KNOT OF SUTURE WAS FOUND TO BE BROKEN. CHANGED TO ANOTHER SUTURE FOR REPAIR. THERE WAS NO REGURGITATION DETECTED BEFORE CLOSING THE CHEST. HOWEVER, A FEW DAYS LATER, REGURGITATION WAS DETECTED AGAIN AND A SECOND THORACOTOMY WAS PERFORMED. DURING THAT PROCEDURE, THE SUTURE BODY WAS FOUND TO BE BROKEN. CHANGED ANOTHER SUTURE FOR REPAIR. NO REGURGITATION WAS DETECTED BEFORE CLOSING THE CHEST. TODAY REGURGITATION WAS DETECTED AGAIN. AT THAT TIME, IT WAS NOT DETERMINED IF THE PATIENT WAS GOING TO UNDERGO A REPAIR OR VALVE REPLACEMENT IN THE NEXT SURGERY. IT WAS LATER REPORTED THAT THE PATIENT UNDERWENT RE-OPERATION AND THE PATIENT HAD A VALVE REPLACEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23788148 ↗
• InjuryDec 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE REPAIR ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON MADE CONTINUED KNOTTING AND ULTRASONIC DETECTION SHOWED NO PROBLEM BEFORE CLOSING THE CHEST. A FEW DAYS AFTER THE PROCEDURE, REGURGITATION WAS DETECTED. THE PATIENT UNDERWENT A FIRST THORACOTOMY. DURING THE PROCEDURE, THE KNOT OF SUTURE WAS FOUND TO BE BROKEN. CHANGED TO ANOTHER SUTURE FOR REPAIR. THERE WAS NO REGURGITATION DETECTED BEFORE CLOSING THE CHEST. HOWEVER, A FEW DAYS LATER, REGURGITATION WAS DETECTED AGAIN AND A SECOND THORACOTOMY WAS PERFORMED. DURING THAT PROCEDURE, THE SUTURE BODY WAS FOUND TO BE BROKEN. CHANGED ANOTHER SUTURE FOR REPAIR. NO REGURGITATION WAS DETECTED BEFORE CLOSING THE CHEST. TODAY REGURGITATION WAS DETECTED AGAIN. AT THAT TIME, IT WAS NOT DETERMINED IF THE PATIENT WAS GOING TO UNDERGO A REPAIR OR VALVE REPLACEMENT IN THE NEXT SURGERY. IT WAS LATER REPORTED THAT THE PATIENT UNDERWENT RE-OPERATION AND THE PATIENT HAD A VALVE REPLACEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23788147 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE REPAIR ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON MADE CONTINUED KNOTTING AND ULTRASONIC DETECTION SHOWED NO PROBLEM BEFORE CLOSING THE CHEST. A FEW DAYS AFTER THE PROCEDURE, REGURGITATION WAS DETECTED. THE PATIENT UNDERWENT A FIRST THORACOTOMY. DURING THE PROCEDURE, THE KNOT OF SUTURE WAS FOUND TO BE BROKEN. CHANGED TO ANOTHER SUTURE FOR REPAIR. THERE WAS NO REGURGITATION DETECTED BEFORE CLOSING THE CHEST. HOWEVER, A FEW DAYS LATER, REGURGITATION WAS DETECTED AGAIN AND A SECOND THORACOTOMY WAS PERFORMED. DURING THAT PROCEDURE, THE SUTURE BODY WAS FOUND TO BE BROKEN. CHANGED ANOTHER SUTURE FOR REPAIR. NO REGURGITATION WAS DETECTED BEFORE CLOSING THE CHEST. TODAY REGURGITATION WAS DETECTED AGAIN. AT THAT TIME, IT WAS NOT DETERMINED IF THE PATIENT WAS GOING TO UNDERGO A REPAIR OR VALVE REPLACEMENT IN THE NEXT SURGERY. IT WAS LATER REPORTED THAT THE PATIENT UNDERWENT RE-OPERATION AND THE PATIENT HAD A VALVE REPLACEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23788146 ↗
• MalfunctionDec 8, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT (AVR) PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING OPEN AORTIC VALUE REPLACEMENT, THE TWO SUTURES WERE DETACHED DURING USE. AFTER THE SURGERY, THE DOCTOR OPENED THE PACKAGE AND TIED ONE SUTURE, THE SAME PHENOMENON OF DETACHING SUTURE OCCURRED. THE DOCTOR OBVIOUSLY HAS DOUBTS THAT THE DEFECT OCCURRED TO THE PRODUCT. THE DOCTOR REPLACED THEM WITH ANOTHER PRODUCT WHICH HAS A DIFFERENT LOT NUMBER AND COMPLETED THE CASE. 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 23745576 ↗
• MalfunctionDec 8, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT (AVR) PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING OPEN AORTIC VALUE REPLACEMENT, THE TWO SUTURES WERE DETACHED DURING USE. AFTER THE SURGERY, THE DOCTOR OPENED THE PACKAGE AND TIED ONE SUTURE, THE SAME PHENOMENON OF DETACHING SUTURE OCCURRED. THE DOCTOR OBVIOUSLY HAS DOUBTS THAT THE DEFECT OCCURRED TO THE PRODUCT. THE DOCTOR REPLACED THEM WITH ANOTHER PRODUCT WHICH HAS A DIFFERENT LOT NUMBER AND COMPLETED THE CASE. 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 23745538 ↗
• MalfunctionDec 8, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT (AVR) PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING OPEN AORTIC VALUE REPLACEMENT, THE TWO SUTURES WERE DETACHED DURING USE. AFTER THE SURGERY, THE DOCTOR OPENED THE PACKAGE AND TIED ONE SUTURE, THE SAME PHENOMENON OF DETACHING SUTURE OCCURRED. THE DOCTOR OBVIOUSLY HAS DOUBTS THAT THE DEFECT OCCURRED TO THE PRODUCT. THE DOCTOR REPLACED THEM WITH ANOTHER PRODUCT WHICH HAS A DIFFERENT LOT NUMBER AND COMPLETED THE CASE. 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 23745526 ↗
• MalfunctionDec 8, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT (AVR) PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING OPEN AORTIC VALUE REPLACEMENT, THE TWO SUTURES WERE DETACHED DURING USE. AFTER THE SURGERY, THE DOCTOR OPENED THE PACKAGE AND TIED ONE SUTURE, THE SAME PHENOMENON OF DETACHING SUTURE OCCURRED. THE DOCTOR OBVIOUSLY HAS DOUBTS THAT THE DEFECT OCCURRED TO THE PRODUCT. THE DOCTOR REPLACED THEM WITH ANOTHER PRODUCT WHICH HAS A DIFFERENT LOT NUMBER AND COMPLETED THE CASE. 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 23745525 ↗
• MalfunctionDec 8, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT (AVR) PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING OPEN AORTIC VALUE REPLACEMENT, THE TWO SUTURES WERE DETACHED DURING USE. AFTER THE SURGERY, THE DOCTOR OPENED THE PACKAGE AND TIED ONE SUTURE, THE SAME PHENOMENON OF DETACHING SUTURE OCCURRED. THE DOCTOR OBVIOUSLY HAS DOUBTS THAT THE DEFECT OCCURRED TO THE PRODUCT. THE DOCTOR REPLACED THEM WITH ANOTHER PRODUCT WHICH HAS A DIFFERENT LOT NUMBER AND COMPLETED THE CASE. 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 23745488 ↗
• MalfunctionDec 8, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT (AVR) PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING OPEN AORTIC VALUE REPLACEMENT, THE TWO SUTURES WERE DETACHED DURING USE. AFTER THE SURGERY, THE DOCTOR OPENED THE PACKAGE AND TIED ONE SUTURE, THE SAME PHENOMENON OF DETACHING SUTURE OCCURRED. THE DOCTOR OBVIOUSLY HAS DOUBTS THAT THE DEFECT OCCURRED TO THE PRODUCT. THE DOCTOR REPLACED THEM WITH ANOTHER PRODUCT WHICH HAS A DIFFERENT LOT NUMBER AND COMPLETED THE CASE. 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 23745485 ↗
• MalfunctionDec 8, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT (AVR) PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING OPEN AORTIC VALUE REPLACEMENT, THE TWO SUTURES WERE DETACHED DURING USE. AFTER THE SURGERY, THE DOCTOR OPENED THE PACKAGE AND TIED ONE SUTURE, THE SAME PHENOMENON OF DETACHING SUTURE OCCURRED. THE DOCTOR OBVIOUSLY HAS DOUBTS THAT THE DEFECT OCCURRED TO THE PRODUCT. THE DOCTOR REPLACED THEM WITH ANOTHER PRODUCT WHICH HAS A DIFFERENT LOT NUMBER AND COMPLETED THE CASE. 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 23745483 ↗
• MalfunctionNov 26, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, NEEDLE PORTION HAD FOREIGN MATTER (MICROSCOPIC PARTICLES) FOUND ON PROLENE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657915 ↗
• MalfunctionNov 26, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, NEEDLE PORTION HAD FOREIGN MATTER (MICROSCOPIC PARTICLES) FOUND ON PROLENE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657914 ↗
• MalfunctionNov 6, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING A CARDIOVASCULAR PROCEDURE, THAT THE STRAND OF THE SUTURE KEPT BREAKING AS THEY WERE HAND TYING. 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 23485945 ↗

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-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• 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
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• 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-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031

…and 6 more.