PROLENE 8871HRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031021549), received between Apr 13, 2020 and Sep 12, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2025Device 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 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SCRUB TECH NOTICED A PIECE HANGING OFF THE NEEDLE AT THE SWAGE. IT WAS DARK IN COLOR, SAME AS THE NEEDLE. WHEN SCRUB PLACED BACK IN PACKAGING, THE PIECE CAME OFF. THIS SUTURE WAS NOT USED ON PATIENT, IT WAS REMOVED FROM FIELD IMMEDIATELY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23039068 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN CHEST OF RIGHT UPPER LOBECTOMY FOR RIGHT UPPER LOBE LUNG ADENOCARCINOMA (STAGE 2B) ON AN UNKOWN DATE AND SUTURE WAS USED. DURING THE OPERATION, 2 CENTIMETERS OF THE RIGHT MAIN BRONCHIAL OF THE MEMBRANOUS PORTION WAS INJURED BY DISSECTING FORCEPS DURING PERIBRONCHIAL DISSECTION, AND THE INJURED AREA WAS REPAIRED BY 2 STITCHES WITH SUTURE WITH A PREJET. AFTERWARDS, IT WAS COVERED WITH A FACTOR XIII WITH FIBRINOGEN FORMULATION AND A POLYGLYCOLIC ACID SHEET. THE PATIENT HAD A GOOD POSTOPERATIVE COURSE, BUT ABOUT 1 YEAR AND 3 MONTHS AFTER SURGERY, A BLOODY SPUTUM APPEARED. TRANEXAMIC ACID ADMINISTRATION CAUSED REMISSION, BUT ABOUT 1 YEAR AND 5 MONTHS AFTER SURGERY, THE BLOODY SPUTUM RELAPSED AND WHEEZING WAS ALSO RECOGNIZED, SO BRONCHOSCOPY WAS EXAMINED. AS A RESULT, PREJET AND SUTURE WERE EXPOSURE, AND HEMORRHAGIC FORMATION OF GRANULOMA WERE RECOGNIZED AT THE RIGHT MAIN BRONCHIAL MEMBRANOUS PORTION. IN ADDITION, CT SCAN SHOWED THAT THE PREJET OF THE SUTURE AREA APPEARED INTO THE BRONCHIAL LUMEN WITH THE POSTOPERATIVE COURSE, AND IT WAS RECOGNIZED THAT PROTRUSION INTO THE TRACHEA INNER CAVITY BY CT SCAN AT 1 YEAR AND 5 MONTHS AFTER THE OP

  Patient problems: Granuloma; Hemorrhage/Blood Loss/Bleeding; Ischemia; Necrosis; Pneumonia; Pocket Erosion; Unspecified Infection

  MAUDE report 20153914 ↗
• MalfunctionDec 22, 2020Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE FRAYED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11058393 ↗
• MalfunctionApr 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ILEOCOLIC RESECTION BY LAPAROTOMY ON (B)(6) 2020 AND SUTURE WAS USED ON THE DIGESTIVE TRACT TISSUE. DURING THE PROCEDURE, AT THE SUTURE OF A STAPLING LINE, THE STRAND PULLED OFF THE NEEDLE. THE WHOLE NEEDLE REMAINED INSIDE THE PATIENT, HOWEVER, TIP OF THE NEEDLE WAS VISIBLE SO THE SURGEON COULD RETRIEVE IT WITH A NEEDLE HOLDER. THERE WAS NO TISSUE DAMAGE AS A RESULT OF SEARCHING FOR THE NEEDLE PIECE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9953626 ↗
• MalfunctionApr 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ILEOCOLIC RESECTION BY LAPAROTOMY ON (B)(6) 2020 AND SUTURE WAS USED ON THE DIGESTIVE TRACT TISSUE. DURING THE PROCEDURE, AT THE SUTURE OF A STAPLING LINE, THE STRAND PULLED OFF THE NEEDLE. THE WHOLE NEEDLE REMAINED INSIDE THE PATIENT, HOWEVER, TIP OF THE NEEDLE WAS VISIBLE SO THE SURGEON COULD RETRIEVE IT WITH A NEEDLE HOLDER. THERE WAS NO TISSUE DAMAGE AS A RESULT OF SEARCHING FOR THE NEEDLE PIECE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9953621 ↗
• MalfunctionApr 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ILEOCOLIC RESECTION BY LAPAROTOMY ON (B)(6) 2020 AND SUTURE WAS USED ON THE DIGESTIVE TRACT TISSUE. DURING THE PROCEDURE, AT THE SUTURE OF A STAPLING LINE, THE STRAND PULLED OFF THE NEEDLE. THE WHOLE NEEDLE REMAINED INSIDE THE PATIENT, HOWEVER, TIP OF THE NEEDLE WAS VISIBLE SO THE SURGEON COULD RETRIEVE IT WITH A NEEDLE HOLDER. THERE WAS NO TISSUE DAMAGE AS A RESULT OF SEARCHING FOR THE NEEDLE PIECE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9953619 ↗
• MalfunctionApr 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ILEOCOLIC RESECTION BY LAPAROTOMY ON (B)(6) 2020 AND SUTURE WAS USED ON THE DIGESTIVE TRACT TISSUE. DURING THE PROCEDURE, AT THE SUTURE OF A STAPLING LINE, THE STRAND PULLED OFF THE NEEDLE. THE WHOLE NEEDLE REMAINED INSIDE THE PATIENT, HOWEVER, TIP OF THE NEEDLE WAS VISIBLE SO THE SURGEON COULD RETRIEVE IT WITH A NEEDLE HOLDER. THERE WAS NO TISSUE DAMAGE AS A RESULT OF SEARCHING FOR THE NEEDLE PIECE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9953618 ↗

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-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• 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-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768

…and 6 more.