PROLENE 8581HRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10705031017368), received between Apr 3, 2019 and Aug 18, 2026 — classified as 1 death, 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2026Break

  Patient problems: Foreign Body In Patient

  MAUDE report 50307088 ↗
• DeathMar 6, 2026Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEART TRANSPLANT PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SURGERY WENT WELL AND THE PATIENT LEFT THE OR. JUST PRIOR TO TRANSFER TO THE ICU, THE PATIENT'S BLOOD PRESSURE DECREASED AND CHEST TUBES FILLED WITH BLOOD. THE CHEST WAS EMERGENTLY PREPPED AND DRAPED AND REOPENED. THE AORTIC ANASTOMOSIS APPEARED TO HAVE DEHISCED. THERE WAS EVIDENCE THAT THE SUTURE BROKE. AN INTERRUPTED SUTURE WAS PLACED TO ACHIEVE TEMPORARY HEMOSTASIS WHILE THE PATIENT WAS RE-HEPARINIZED FOR CARDIOPULMONARY BYPASS. THE PATIENT WAS RE-CANNULATED AND DIALYSIS WAS INITIATED DUE TO SEVERE HYPERKALEMIA AND METABOLIC DERANGEMENT. ANTERIOR ASPECT OF THE AORTIC ANASTOMOSIS WAS REINFORCED. AFTER 45 MINUTES OF REPERFUSION, THE PATIENT WAS WEANED FROM CARDIOPULMONARY BYPASS WITH MODERATE PRESSOR SUPPORT AND INHALED NITRIC OXIDE. BIVENTRICULAR FUNCTION APPEARED REASONABLE. THE PATIENT WAS KEPT IN OR FOR A PERIOD OF OBSERVATION IN THE EVENT TRANSITION TO ECMO REQUIRED. THE PATIENT WAS TRANSFERRED TO ICU. THE PATIENT DID NOT RECOVER AND PASSED AWAY ON (B)(6) 2026. THE AUTOPSY CONFIRMED BROKEN SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Wound Dehiscence

  MAUDE report 24532695 ↗
• MalfunctionFeb 13, 2026Dull, Blunt

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, WHEN THE PRODUCT WAS USED ON CARBONIZED TISSUE, THE NEEDLE DID NOT GO THROUGH WELL. THE ISSUE MAY BE DUE TO THE CONDITION OF THE BODY SITE OR POSSIBLY THE PRODUCT, SO THE HOSPITAL IS REQUESTING AN INVESTIGATION. THE CLINICAL DEPARTMENT AND SURGICAL SITE ARE CURRENTLY UNKNOWN. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. DURING VISUAL INSPECTION OF THE RETURNED SAMPLE, SIGNIFICANT MARKS COULD BE OBSERVED ON THE BODY NEEDLES. THE TIP OF THE NEEDLES WAS EXAMINED AND ONE WAS BROKEN AT THE TIP AREA. WHILE THE OTHER NEEDLE NO ISSUES RELATED TO BREAKAGE NEEDLE WERE NOTED DURING THE EVALUATION. THE SAMPLE WILL BE SHIPPED TO HSA FOR FURTHER ANALYSIS DUE TO THE NEEDLE BREAKAGE. 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 24335466 ↗
• MalfunctionJan 14, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE WHEN SEWING IN AN UNKNOWN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24073173 ↗
• MalfunctionJan 5, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN CARDIOVASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE CUSTOMER REPORTED THAT IN A COMPLEX CV CASE, SEVERAL STRANDS OF THE SAME SUTURE WERE BREAKING BEFORE THE SURGEON WAS DONE TYING THEM. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23964357 ↗
• MalfunctionJan 5, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN CARDIOVASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE CUSTOMER REPORTED THAT IN A COMPLEX CV CASE, SEVERAL STRANDS OF THE SAME SUTURE WERE BREAKING BEFORE THE SURGEON WAS DONE TYING THEM. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23964352 ↗
• MalfunctionDec 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEART BYPASS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED 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 23843796 ↗
• MalfunctionDec 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEART BYPASS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. IT WAS REPORTED THAT TOTAL 2 PRODUCTS OCCURRED BREAKAGE SUTURE ISSUE. CHANGED 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 23842624 ↗
• MalfunctionDec 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEART BYPASS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. IT WAS REPORTED THAT TOTAL 2 PRODUCTS OCCURRED BREAKAGE SUTURE ISSUE. CHANGED 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 23842506 ↗
• MalfunctionNov 11, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE OR DIRECTOR THAT A 4-0 PROLENE PACKET WAS WRAPPED IN DYED VICRYL. THE PACKAGE WAS NOT OPENED AND INSPECTED PRIOR TO OPENING IN THE STERILE FIELD. NO IMPACT TO PATIENT AS IT WAS NOT OPENED. ONE DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23525191 ↗
• MalfunctionOct 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SALES REP REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE NEEDLE KEPT POPPING OFF THE SUTURE. NO PATIENT CONSEQUENCES WERE REPORTED. THE DEVICE IS AVAILABLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301038 ↗
• MalfunctionOct 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SALES REP REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE NEEDLE KEPT POPPING OFF THE SUTURE. NO PATIENT CONSEQUENCES WERE REPORTED. THE DEVICE IS AVAILABLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23300162 ↗
• MalfunctionFeb 12, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC ANEURYSM PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE ANASTOMOSIS THE SUTURE FRAYED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18690294 ↗
• InjuryJul 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT AN INQUIRY CAME FROM THE SURGEON ABOUT HOW TO SEARCH A NEEDLE WHICH WAS LEFT INSIDE THE BODY. IT WAS NOT SURE, BUT IT SEEMS LIKE A NEEDLE HAS BEEN LEFT INSIDE THE BODY. THE PRODUCT CODE WAS UNCERTAIN, BUT 2 POSSIBLE PRODUCT CODES WERE PROVIDED. IT WAS STATED THERE IS A HIGH POSSIBILITY THAT THE NEEDLE HAD BEEN LEFT INSIDE OF THE BODY. THE SURGEON DID NOT PROVIDE AN OPINION ABOUT CAUSAL RELATIONSHIP BETWEEN PRODUCT AND EVENT. NO FURTHER DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17338897 ↗
• MalfunctionNov 22, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE SNAPPED OFF WITHOUT PRESSURE OR PULLING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15847219 ↗
• MalfunctionJun 6, 2022Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE EASILY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14608821 ↗
• MalfunctionDec 16, 2021Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE REPAIR PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THERE WERE SUTURE BREAKAGES AND SPLICING DURING SUTURING AND KNOTTING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13023536 ↗
• MalfunctionDec 16, 2021Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE REPAIR PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THERE WERE SUTURE BREAKAGES AND SPLICING DURING SUTURING AND KNOTTING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13023535 ↗
• MalfunctionDec 16, 2021Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE REPAIR PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THERE WERE SUTURE BREAKAGES AND SPLICING DURING SUTURING AND KNOTTING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13023534 ↗
• MalfunctionDec 19, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A UNKNOWN PROCEDURE ON (B)(6) 2019 AND THE SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN TYING IT. IT WAS NOT A CONTROL RELEASE NEEDLE. THE SURGEON OPINED THAT NO EXTRA FORCE WAS APPLIED TO THE SUTURE AT THAT TIME. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9493153 ↗
• MalfunctionDec 2, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. BEFORE OPENING THE PACKAGE, IT WAS FOUND THAT THE NEEDLE TIP HAD PROTRUDED FROM THE TRAY INSIDE THE ALUMINUM PACKAGE. THE SURGEON WAS NOT SURE IF THE NEEDLE TIP HAD PENETRATED THE ALUMINUM PACKAGE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9398579 ↗
• MalfunctionApr 3, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT ON (B)(6 )2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHILE TYING THE KNOT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE LIKE DEVICE WITH NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8479719 ↗

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-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• 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-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• 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
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768

…and 6 more.