PROLENE 2790GRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031003859), received between Dec 11, 2017 and Feb 26, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. AT 10 O'CLOCK, WHILE SUTURING BLOOD VESSELS WITH SUTURE, THE DOCTOR FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. AFTER HANDING IT OVER TO THE HAND WASHING NURSE, THE NURSE ATTEMPTED TO CLAMP THE NEEDLE ONTO A PAD. DURING THE CLAMPING PROCESS, THE NEEDLE BOUNCED AWAY, CAUSING THE NEEDLE TO BE LOST. THE NURSE IMMEDIATELY SEARCHED AROUND THE SURGICAL AREA AND TOOK PHOTOS BUT COULD NOT FIND IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24461339 ↗
• MalfunctionDec 31, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT WHEN PREPARING FOR USE BEFORE SURGERY, IT WAS FOUND THAT THE SUTURE IS PRESSED ON THE OUTSIDE OF THE PACKAGING, NOT STERILE SUTURE. 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 23933624 ↗
• MalfunctionAug 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON WAS ANASTOMOSING THE BLOOD VESSEL, IT WAS FOUND THAT THE NEEDLE PULLED OFF THE SUTURE. THE SUTURE WAS REMOVED AND REPLACED WITH THE SAME MODEL SUTURE FOR RE-ANASTOMOSIS. ANESTHESIA WAS PROLONGED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22793629 ↗
• MalfunctionAug 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON WAS ANASTOMOSING THE BLOOD VESSEL, IT WAS FOUND THAT THE NEEDLE PULLED OFF THE SUTURE. THE SUTURE WAS REMOVED AND REPLACED WITH THE SAME MODEL SUTURE FOR RE-ANASTOMOSIS. ANESTHESIA WAS PROLONGED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22793627 ↗
• MalfunctionAug 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON WAS ANASTOMOSING THE BLOOD VESSEL, IT WAS FOUND THAT THE NEEDLE PULLED OFF THE SUTURE. THE SUTURE WAS REMOVED AND REPLACED WITH THE SAME MODEL SUTURE FOR RE-ANASTOMOSIS. ANESTHESIA WAS PROLONGED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22793626 ↗
• MalfunctionAug 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON WAS ANASTOMOSING THE BLOOD VESSEL, IT WAS FOUND THAT THE NEEDLE PULLED OFF THE SUTURE. THE SUTURE WAS REMOVED AND REPLACED WITH THE SAME MODEL SUTURE FOR RE-ANASTOMOSIS. ANESTHESIA WAS PROLONGED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22793625 ↗
• MalfunctionApr 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE TWO TIMES AND WERE LATER RETRIEVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19153866 ↗
• MalfunctionApr 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE TWO TIMES AND WERE LATER RETRIEVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19153860 ↗
• MalfunctionSep 8, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. 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 17711932 ↗
• MalfunctionJun 1, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN NEUROSURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN EASILY DURING CONTINUOUS SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10105957 ↗
• MalfunctionDec 11, 2017Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED BY A SALES THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2017 AND SUTURE WAS USED. IT WAS FOUND THAT THE SUTURE HAD BEEN CAUGHT AT THE SEALED AREA OF THE PACKAGE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7107240 ↗

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-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-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• 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-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988

…and 6 more.