PROLENE EH7585HRecalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 10705031097254), received between Jul 25, 2019 and Sep 30, 2026 — classified as 63 malfunctions.

The most frequently reported specific device problem is “Break” (56 reports).

1 FDA recall record name this device's identifier, 1 still open.

20 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.

Recalls naming this device

1. Dec 20, 2024Open, Classified

   Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

   Z-1096-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949724 ↗
• MalfunctionSep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949699 ↗
• MalfunctionSep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949684 ↗
• MalfunctionSep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949668 ↗
• MalfunctionJun 10, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING A CARDIAC SURGERY, THE SUTURE TENDS TO BREAK EASILY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25457076 ↗
• MalfunctionApr 29, 2026Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE WIRES FRAY AND SPLIT DURING TYING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25034978 ↗
• MalfunctionApr 29, 2026Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE WIRES FRAY AND SPLIT DURING TYING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25034968 ↗
• MalfunctionApr 23, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE NURSE SAID THAT THE NEEDLE AT THE PROXIMAL END WAS DIRTY. THIS EVENT WAS FOUND BEFORE USE. 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 24967641 ↗
• MalfunctionMar 17, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, IT WAS FOUND THAT ONE SIDE OF THE NEEDLE HAD BEEN DETACHED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. 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 24616963 ↗
• MalfunctionMar 9, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN CARDIOVASCULAR SURGERY, ALTHOUGH THE NURSE AND THE DOCTOR PULLED OUT THE NEEDLE-SUTURE, IT COULD NOT BE TAKEN OUT FROM THE STERILE PACKAGE. THE PRODUCT WAS NOT USED FOR THE PATIENT. 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 24551619 ↗
• MalfunctionMar 9, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN CARDIOVASCULAR SURGERY, ALTHOUGH THE NURSE AND THE DOCTOR PULLED OUT THE NEEDLE-SUTURE, IT COULD NOT BE TAKEN OUT FROM THE STERILE PACKAGE. THE PRODUCT WAS NOT USED FOR THE PATIENT. 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 24551615 ↗
• MalfunctionMar 9, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN CARDIOVASCULAR SURGERY, ALTHOUGH THE NURSE AND THE DOCTOR PULLED OUT THE NEEDLE-SUTURE, IT COULD NOT BE TAKEN OUT FROM THE STERILE PACKAGE. THE PRODUCT WAS NOT USED FOR THE PATIENT. 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 24551614 ↗
• MalfunctionJan 24, 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 A SALES REP THAT, DURING AN UNKNOWN CARDIOVASCULAR SURGERY, EIGHT SUTURES WERE USED FROM THE BOX OF THE LOT INVOLVED, AND THE ENTIRE BOX WAS RETURNED TO SPD DUE TO THE SUTURE BREAKAGE CONTINUOUSLY OCCURRED TOO MUCH. AFTERWARDS, ANOTHER LOT WAS USED, AND THERE WAS NO EFFECT ON THE SURGERY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21234631 ↗
• MalfunctionJan 24, 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 A SALES REP THAT, DURING AN UNKNOWN CARDIOVASCULAR SURGERY, EIGHT SUTURES WERE USED FROM THE BOX OF THE LOT INVOLVED, AND THE ENTIRE BOX WAS RETURNED TO SPD DUE TO THE SUTURE BREAKAGE CONTINUOUSLY OCCURRED TOO MUCH. AFTERWARDS, ANOTHER LOT WAS USED, AND THERE WAS NO EFFECT ON THE SURGERY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21234599 ↗
• MalfunctionJan 24, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON 07-01-2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN CARDIOVASCULAR SURGERY, EIGHT SUTURES WERE USED FROM THE BOX OF THE LOT INVOLVED, AND THE ENTIRE BOX WAS RETURNED TO SPD DUE TO THE SUTURE BREAKAGE CONTINUOUSLY OCCURRED TOO MUCH. AFTERWARDS, ANOTHER LOT WAS USED, AND THERE WAS NO EFFECT ON THE SURGERY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21234593 ↗
• MalfunctionJan 24, 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 A SALES REP THAT, DURING AN UNKNOWN CARDIOVASCULAR SURGERY, EIGHT SUTURES WERE USED FROM THE BOX OF THE LOT INVOLVED, AND THE ENTIRE BOX WAS RETURNED TO SPD DUE TO THE SUTURE BREAKAGE CONTINUOUSLY OCCURRED TOO MUCH. AFTERWARDS, ANOTHER LOT WAS USED, AND THERE WAS NO EFFECT ON THE SURGERY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21234456 ↗
• MalfunctionJan 24, 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 A SALES REP THAT, DURING AN UNKNOWN CARDIOVASCULAR SURGERY, EIGHT SUTURES WERE USED FROM THE BOX OF THE LOT INVOLVED, AND THE ENTIRE BOX WAS RETURNED TO SPD DUE TO THE SUTURE BREAKAGE CONTINUOUSLY OCCURRED TOO MUCH. AFTERWARDS, ANOTHER LOT WAS USED, AND THERE WAS NO EFFECT ON THE SURGERY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21234450 ↗
• MalfunctionJan 24, 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 A SALES REP THAT, DURING AN UNKNOWN CARDIOVASCULAR SURGERY, EIGHT SUTURES WERE USED FROM THE BOX OF THE LOT INVOLVED, AND THE ENTIRE BOX WAS RETURNED TO SPD DUE TO THE SUTURE BREAKAGE CONTINUOUSLY OCCURRED TOO MUCH. AFTERWARDS, ANOTHER LOT WAS USED, AND THERE WAS NO EFFECT ON THE SURGERY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21234448 ↗
• MalfunctionJan 24, 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 A SALES REP THAT, DURING AN UNKNOWN CARDIOVASCULAR SURGERY, EIGHT SUTURES WERE USED FROM THE BOX OF THE LOT INVOLVED, AND THE ENTIRE BOX WAS RETURNED TO SPD DUE TO THE SUTURE BREAKAGE CONTINUOUSLY OCCURRED TOO MUCH. AFTERWARDS, ANOTHER LOT WAS USED, AND THERE WAS NO EFFECT ON THE SURGERY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21234444 ↗
• MalfunctionJan 24, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON 07-01-2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN CARDIOVASCULAR SURGERY, EIGHT SUTURES WERE USED FROM THE BOX OF THE LOT INVOLVED, AND THE ENTIRE BOX WAS RETURNED TO SPD DUE TO THE SUTURE BREAKAGE CONTINUOUSLY OCCURRED TOO MUCH. AFTERWARDS, ANOTHER LOT WAS USED, AND THERE WAS NO EFFECT ON THE SURGERY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21234442 ↗
• MalfunctionOct 14, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING AN UNKNOWN CARDIOVASCULAR SURGERY, DURING CONTINUOUS SUTURING. THE SUTURE WAS BROKEN EASILY DURING ANASTOMOSIS. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20440443 ↗
• MalfunctionFeb 13, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LIVER TRANSPLANTATION PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696922 ↗
• MalfunctionFeb 13, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LIVER TRANSPLANTATION PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696918 ↗
• MalfunctionFeb 13, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LIVER TRANSPLANTATION PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696910 ↗
• MalfunctionJan 30, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE SURGERY, THE NEEDLE BROKE AT THE BODY PART DURING ANASTOMOSIS ON PANCREAS. THE SURGEON LOOKED FOR THE BROKEN NEEDLE AND EVENTUALLY THE BROKEN NEEDLE WAS FOUND IN THE BODY. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608814 ↗

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-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• 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-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• 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-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981

…and 5 more.