PROLENE 8526HRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10705031016644), received between Apr 21, 2021 and Sep 2, 2026 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50570966 ↗
• MalfunctionSep 2, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50570753 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LIVER TRANSPLANT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DOCTOR HAS OBSERVED THAT THE SUTURES ARE BREAKING WHILE USING INTRA OPERATIVELY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24704563 ↗
• MalfunctionJan 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24082979 ↗
• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REPAIR OF ATRIAL SEPTAL DEFECT PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON USED SUTURE TO SEW THE RIGHT ATRIUM DURING THE SURGERY. WHEN THE SUTURE WAS FINISHED AND RETURNED TO THE HAND WASHING NURSE, IT WAS IMMEDIATELY FOUND TO HAVE A 2MM NEEDLE TIP DEFECT, AND IMMEDIATELY SEARCHED IN VIVO AND IN VITRO, BUT WAS UNSUCCESSFUL. AFTER THE SURGERY, THE RADIOLOGY DEPARTMENT TOOK AN X-RAY AND THERE WERE NO RESIDUES IN THE BODY. THE PATIENT THEN LEFT THE ROOM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23923354 ↗
• MalfunctionAug 27, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR ACUTE EXACERBATION OF CHRONIC CHOLECYSTITIS ACCOMPANIED BY GALLSTONES ON (B)(6) 2025 AND SUTURE WAS USED. THE SURGERY WAS PERFORMED AT 14:00 ON THE SAME DAY, AND AT 14:33, MEDICAL STAFF WAS USING SUTURE TO SUTURE THE GALLBLADDER BED TO STOP BLEEDING. AT 14:34, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, MAKING IT DIFFICULT TO REMOVE THE NEEDLE FROM THE LIVER. AT 14:35, MEDICAL STAFF IMMEDIATELY SUSPENDED THE SURGERY TO SEARCH FOR THE NEEDLE, WHICH WAS FOUND. THE SURGERY IS PROCEEDING NORMALLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22907378 ↗
• MalfunctionJun 25, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY CUSTOMER THAT SUTURE WAS BREAKING DURING PROCEDURE. SURGICAL DELAY UNKNOWN. NO PATIENT HARM WAS REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329521 ↗
• MalfunctionJun 25, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY CUSTOMER THAT SUTURE WAS BREAKING DURING PROCEDURE. SURGICAL DELAY UNKNOWN. NO PATIENT HARM WAS REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329516 ↗
• MalfunctionFeb 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN MITRAL VALVE PLASTY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN OPEN MITRAL VALVE PLASTY (MVP), THE SUTURE WAS BROKEN (FINE SPLIT) DURING THE LEFT ATRIAL WALL INCISIONAL WOUND CLOSURE ON (B)(6) 12PM. THE PRODUCT WAS A DOUBLE-ARMED SUTURE AND IT WAS USED FOR CONTINUOUS SUTURING WITH THE ONE SIDE NEEDLE DROPPED. THE SIDE WHERE IS CUT OFF THE NEEDLE HAD A FINE SPLIT, SO THE USE WAS STOPPED ON THE WAY. A NEW ONE WITH THE SAME PRODUCT CODE WAS OPENED AND SUTURING WAS COMPLETED. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21433155 ↗
• MalfunctionNov 11, 2024Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND A SUTURE DEVICE WAS USED. WHILE PERFORMING TRAUMA SUTURING ON A PATIENT, IT WAS FOUND THAT THE SUTURE HAD BURRS AND SPLIT. 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 20655328 ↗
• MalfunctionSep 17, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE SUTURE WAS USED. A FOREIGN MATTER HAS BEEN CONTAMINATED. IT WAS NOT A CONTROL RELEASE NEEDLE.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20241516 ↗
• MalfunctionMar 11, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY A SALES REP THAT, THERE WERE 35 PACKAGES IN THE BOX. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT WAS RECEIVED ONE OPEN BOX THAT PERTAIN TO PRODUCT CODE 8526H. UPON THE VISUAL INSPECTION OF THE RECEIVED BOX, IT WAS FOUND THAT CONTAINED THIRTY-FIVE PACKETS INSTEAD OF THIRTY-SIX PACKETS. AS PER PRODUCT REQUIREMENTS, THE BOX SHOULD CONTAIN THIRTY-SIX PACKAGES. IN ADDITION, IT WAS NOTED THAT THE TAB DISPENSER WAS REMOVED FROM THE BOX. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874327 ↗
• MalfunctionJan 31, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG AND MVR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS HAVING A BLUNT SUTURE NEEDLE, ONE OF THE PACKING ONLY HAVE NEEDLE BUT NO SUTURE, AND HIGHLIGHTED THAT IT EASILY SNAPPED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18614527 ↗
• MalfunctionJan 31, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG AND MVR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS HAVING A BLUNT SUTURE NEEDLE, ONE OF THE PACKING ONLY HAVE NEEDLE BUT NO SUTURE, AND HIGHLIGHTED THAT IT EASILY SNAPPED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18614524 ↗
• MalfunctionJul 27, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE UNKNOWN SURGERY, THERE IS A POSSIBILITY THAT THE NEEDLE WAS BROKEN AT THE SWAGE PART DURING USE. NO BROKEN NEEDLE FELL INTO THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17405588 ↗
• MalfunctionJul 12, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND A SUTURE WAS USED. DURING THE SUTURING OF THE AORTA, THE NEEDLE DETACHED FROM THE SWAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17313340 ↗
• MalfunctionApr 6, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE DETACHED FROM THE NEEDLE SWAGE AFTER MULTIPLE PASSES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16690985 ↗
• MalfunctionMar 27, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MITRAL VALVE REPLACEMENT PROCEDURE ON (B)(6) 2023 AND SUTURE WERE USED. DURING THE PROCEDURE, THE SUTURE DETACHED FROM NEEDLE INTRA-OP. NEEDLE WAS FOUND AND DISCARDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16625191 ↗
• MalfunctionFeb 21, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC ANEURYSM PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON IS DOING THE SUTURING OF THE AORTA. 5 OF THE SUTURES WAS DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16411429 ↗
• MalfunctionFeb 21, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC ANEURYSM PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON IS DOING THE SUTURING OF THE AORTA. 5 OF THE SUTURES WAS DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16411374 ↗
• MalfunctionFeb 21, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC ANEURYSM PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON IS DOING THE SUTURING OF THE AORTA. 5 OF THE SUTURES WAS DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16411371 ↗
• MalfunctionFeb 21, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC ANEURYSM PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON IS DOING THE SUTURING OF THE AORTA. 5 OF THE SUTURES WAS DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16411337 ↗
• MalfunctionFeb 21, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC ANEURYSM PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON IS DOING THE SUTURING OF THE AORTA. 5 OF THE SUTURES WAS DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16411324 ↗
• MalfunctionMay 17, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE SUTURE WAS USED. THE SUTURE BROKE DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14417726 ↗
• MalfunctionNov 23, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2021 AND SUTURE WAS TO BE USED. AFTER THE PACKAGE WAS OPENED, THE NEEDLE HAD BEEN BROKEN AT THE TIP PRIOR TO USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12863174 ↗

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-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• 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-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981

…and 6 more.