PROLENE 8842HRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031021143), received between Apr 18, 2024 and Feb 6, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHILE TYING THE NODE, THE SUTURE WAS DETACHED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24281808 ↗
• MalfunctionDec 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE DOUBLE-ARMED SUTURE WAS DETACHED IN THE MIDDLE BEFORE USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. 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 23791484 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TITLE: A CASE OF SUTURE AND PREJET OF BRONCHUS TRANSECTION STRAYED INTO BRONCHUS LUMEN 1 YEAR AND 3 MONTHS AFTER RADICAL LUNG CANCER SURGERY. IN (B)(6) 2019, A RIGHT LOWER CONFECTIONARY S6 SEGMENTECTOMY WAS PERFORMED FOR RIGHT LUNG CANCER. AT THE TIME OF SURGERY, B6A AND B6B+C WAS BIFURCATED SEPARATELY, AND THEY WERE STAPLED TOGETHER AND DISSECTED USING A STAPLER (SIGNIA, CAMEL CARTRIDGE, COVIDIEN); AN AIR LEAK WAS OBSERVED FROM THE B% TRANSECTION, WHICH WAS CLOSED USING A TEFLON PREJET AND THE PATIENT HAD AN UNCOMPLICATED POSTOPERATIVE COURSE. THE POSTOPERATIVE PATHOLOGICAL STAGE WAS PTLANOMO, STAGE IAI. ONE YEAR AND THREE MONTHS AFTER THE SURGERY WITHOUT RECURRENCE, THE PATIENT CAME TO OUR HOSPITAL WITH A GRADUALLY WORSENING COUGH AND DYSPNEA. ON ARRIVAL, HE WAS 158 CM TALL, 42.1 KG IN WEIGHT, BLOOD FF130/84 MMHG, PULSE 74/MIN, BODY TEMPERATURE 36.2°C, AND SP0298% (ROOM AIR). BLOOD BIOCHEMISTRY FINDINGS: WBC 9100/1, NEUTRO 72.1%, CRP 4.81 MG/DL WERE ALL WITHIN NORMAL LIMITS, INCLUDING TUMOR MARKERS. CHEST X-RAY EXAMINATION FINDINGS: LOW F PERMEABILITY IN THE RIGHT LOWER LUNG FIELD, LOSS OF THE RIGHT SECOND ARCH, AND FINDINGS SUGGESTIVE OF RIGHT MIDDLE LOBE PNEUMONIA WERE OBSERVED

  Patient problems: Erythema; Fever; Insufficient Information; Swelling/ Edema

  MAUDE report 19924930 ↗
• MalfunctionApr 18, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, A SMALL FOREIGN SUBSTANCE WAS OBSERVED INSIDE THE SUTURE PACKAGE PRIOR TO OPENING THE PACKAGE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19137672 ↗

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-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-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• 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

…and 6 more.