PROLENE 8534HRecalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10705031016774), received between May 3, 2019 and Sep 24, 2026 — classified as 1 death, 49 malfunctions.

The most frequently reported specific device problem is “Material Separation” (39 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 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Material Separation

  It was reported that a patient underwent an abdominal aortic aneurysm procedure on (b)(6) 2026 and suture was used. It was reported to the sales rep that the account contact left a message that was getting called into surgeon's room as he was doing a AAA. Apparently while he was sewing the needle came off and fell into the pt. There was no patient consequence reported. There was 35mins of surgical delay was reported. The device was returning. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883673 ↗
• MalfunctionSep 24, 2026Material Separation

  It was reported that a patient underwent an abdominal aortic aneurysm procedure on (b)(6) 2026 and suture was used. It was reported to the sales rep that the account contact left a message that was getting called into surgeon's room as he was doing a AAA. Apparently while he was sewing the needle came off and fell into the pt. There was no patient consequence reported. There was 35mins of surgical delay was reported. The device was returning. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883672 ↗
• MalfunctionDec 3, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. THE NEEDLE DETACH FROM THE SUTURE DURING PASSAGE THROUGH TISSUE. (1EA OF 9EA IS UNPACKED AND USED, ALL 9EA ARE RETURNED). THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706528 ↗
• MalfunctionJul 3, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP, THAT DURING AN UNKNOWN PROCEDURE THE SUTURE WAS FRAYING. NO PATIENT CONSEQUENCES. UNKNOWN NUMBER OF STERILE SAMPLES TO RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394873 ↗
• MalfunctionSep 10, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT PANCREATECTOMY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE, THE SUTURE BROKE. 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 20179874 ↗
• MalfunctionSep 10, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT PANCREATECTOMY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE, THE SUTURE BROKE. 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 20179864 ↗
• MalfunctionSep 10, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT PANCREATECTOMY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE, THE SUTURE BROKE. 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 20179856 ↗
• MalfunctionMay 6, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE NEEDLE AND SUTURE WERE SEPARATED. CHANGED TO A NEW DEVICE TO CONTINUE THE SURGERY. THERE WAS NO PATIENT IMPACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19247529 ↗
• DeathJan 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTIFICIAL BLOOD VESSEL REPLACEMENT (DAA TYPEA) ON (B)(6) 2023 14:00 TO (B)(6) 2023 00:40 AND SUTURE WAS USED ON THE AORTA. THE PATIENT WAS IN SERIOUS CONDITION. DURING THE SUTURING PROCESS, THE SUTURE NEEDLE SUDDENLY SEPARATED FROM THE SUTURE, AND THE NEEDLE FELL INTO THE AORTA. DUE TO THE SURGICAL FIELD OF VIEW AND ORGAN STRUCTURE, THE ATTENDING PHYSICIAN FAILED TO SEARCH AND COUNTED 1 LESS SUTURE NEEDLE. THE NURSE NOTIFIED THE SUPERVISOR AND DETERMINED WITH THE SUPERVISOR THAT THE STITCHES REMAINED IN THE BODY AND COULD NOT BE REMOVED. NO PORTABLE X-RAY MACHINE WAS USED DURING SURGERY. THE PROCEDURE WAS DELAYED BY 30 MINUTES. AFTER THE OPERATION, THE PATIENT WAS SENT BACK TO THE WARD AT 00:40 ON (B)(6) 2023 AND UNDERWENT X-RAY IRRADIATION TO CONFIRM THE LOCATION OF THE SUTURE NEEDLE. THE LOCATION OF THE NEEDLE WAS REPORTED AS CLOSED FALSE LUMEN OF AORTIC ANEURYSM. DUE TO THE LOCATION OF THE NEEDLE, THE NEEDLE COULD NOT BE REMOVED. THEREFORE, THE PATIENT¿S HOSPITAL STAY WAS EXTENDED FOR OBSERVATION, AND X-RAY IRRADIATION WAS PERFORMED REGULARLY TO TRACK THE LOCATION OF THE SUTURE NEEDLE. THE HCP CHECKED THE LOCATION THROUGH X-RAY EVERY

  Patient problems: Cardiac Tamponade; Foreign Body In Patient; Thrombosis/Thrombus

  MAUDE report 18495434 ↗
• MalfunctionAug 30, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ABDOMINAL AORTIC ANEURYSM REPAIR PROCEDURE ON 07/08/2023 AND SUTURE WAS USED. DURING THE PROCEDURE, ONE OF THE 3/0 PROLENES AND THE THREAD SPLIT INTO 2 DURING THE ANASTOMOSIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17657263 ↗
• MalfunctionAug 21, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT BEFORE SURGERY ON (B)(6) 2023, THE NURSE FOUND THAN ONE PACKET OF A SUTURE WITH A SPECIFIC PRODUCT CODE AND LOT COMBINATION WAS MIXED INTO A BOX LABELED AS ANOTHER PRODUCT AND LOT NUMBER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17592004 ↗
• MalfunctionJul 12, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE BROKE OFF DURING THE PROCEDURE FROM THE SUTURE MATERIAL WITH NO NEEDLE LEFT IN THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14985910 ↗
• MalfunctionJun 14, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11994319 ↗
• MalfunctionMar 18, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHILE ATTEMPTING TO REMOVE/RETRACT SHUNT DURING COARTATION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11518600 ↗
• MalfunctionDec 5, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS POPPING OFF OF THE NEEDLE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10951136 ↗
• MalfunctionDec 5, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS POPPING OFF OF THE NEEDLE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10951110 ↗
• MalfunctionFeb 6, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6)2019 AND SUTURE WAS USED. WHEN PICKING UP THE NEEDLE-SUTURE WITH THE NEEDLE-HOLDER, THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9679344 ↗
• MalfunctionOct 30, 2019Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AAA ANASTOMOSIS ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD WAS NOTICED TO BE FRAYED. IT HAD NOT COME INTO CONTACT WITH ANY INSTRUMENTS TO CAUSE FRAYING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE SURGEON OPINED THERE WAS POTENTIAL SIGNIFICANT HARM TO PATIENT IF SUTURE THREAD WAS WEAKENED AND HAD COME APART POST-OPERATIVELY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9256909 ↗
• MalfunctionOct 8, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF FROM SUTURE MATERIAL. THE WHOLE NEEDLE SEPARATED / DETACHED FROM THE WHOLE SUTURE THREAD. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9165721 ↗
• MalfunctionOct 8, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF FROM SUTURE MATERIAL. THE WHOLE NEEDLE SEPARATED / DETACHED FROM THE WHOLE SUTURE THREAD. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9165720 ↗
• MalfunctionOct 8, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF FROM SUTURE MATERIAL. THE WHOLE NEEDLE SEPARATED / DETACHED FROM THE WHOLE SUTURE THREAD. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9165717 ↗
• MalfunctionOct 8, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF FROM SUTURE MATERIAL. THE WHOLE NEEDLE SEPARATED / DETACHED FROM THE WHOLE SUTURE THREAD. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9165714 ↗
• MalfunctionOct 8, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF FROM SUTURE MATERIAL. THE WHOLE NEEDLE SEPARATED / DETACHED FROM THE WHOLE SUTURE THREAD. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9165713 ↗
• MalfunctionAug 23, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS SNAPPING OFF THE NEEDLE WHILE IN USE. THERE WERE NO DELAYS TO THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8925556 ↗
• MalfunctionAug 23, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS SNAPPING OFF THE NEEDLE WHILE IN USE. THERE WERE NO DELAYS TO THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8925553 ↗

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-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• 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-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• 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-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067

…and 6 more.