PROLENE 8881HRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031021686), received between Feb 15, 2023 and Oct 14, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024, AND SUTURE WAS USED. PRIOR TO USE ON A PATIENT, BEFORE DELIVERY TO THE HOSPITAL IT WAS REPORTED THAT THERE WERE ONLY 34 PACKAGES IN THE BOX. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. UPON THE VISUAL INSPECTION OF THE RECEIVED BOX, IT WAS FOUND THAT IT CONTAINED ONLY THIRTY-FOUR FOIL PACKETS INSTEAD OF THIRTY-SIX FOILS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20441382 ↗
• MalfunctionFeb 15, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF WITH TISSUE PASSAGE, PUNCTURING A VESSEL. THE NEEDLE COULD BE RECOVERED, AND NO PARTS REMAIN IN PATIENT. THE NEEDLE WAS CAUGHT IN THE NEEDLE HOLDER. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SIGNIFICANT DELAY REPORTED. THE PROCEDURE WAS FINISHED WITH SAME LIKE DEVICE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Perforation of Vessels

  MAUDE report 16379628 ↗
• MalfunctionFeb 15, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF WITH TISSUE PASSAGE, PUNCTURING A VESSEL. THE NEEDLE COULD BE RECOVERED, AND NO PARTS REMAIN IN PATIENT. THE NEEDLE WAS CAUGHT IN THE NEEDLE HOLDER. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SIGNIFICANT DELAY REPORTED. THE PROCEDURE WAS FINISHED WITH SAME LIKE DEVICE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Perforation of Vessels

  MAUDE report 16379624 ↗

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-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• 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-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• 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-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-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631

…and 6 more.