PROLENE 8890HRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10705031021785), received between Jun 18, 2019 and Sep 15, 2022 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREAS PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN THE SURGEON TIED THE FIRST KNOT WHEN SUTURING A VESSEL. THE TRIED WITH 6 ADDITIONAL SUTURES FROM THE SAME LOT AND ALL OF THEM BROKE WHEN HE TIED THE FIRST KNOT. THE OR TIME WAS PROLONGED DUE TO THIS. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15429297 ↗
• MalfunctionSep 15, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREAS PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN THE SURGEON TIED THE FIRST KNOT WHEN SUTURING A VESSEL. THE TRIED WITH 6 ADDITIONAL SUTURES FROM THE SAME LOT AND ALL OF THEM BROKE WHEN HE TIED THE FIRST KNOT. THE OR TIME WAS PROLONGED DUE TO THIS. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15429274 ↗
• MalfunctionSep 15, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREAS PROCEDURE ON 09/08/2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN THE SURGEON TIED THE FIRST KNOT WHEN SUTURING A VESSEL. THE TRIED WITH 6 ADDITIONAL SUTURES FROM THE SAME LOT AND ALL OF THEM BROKE WHEN HE TIED THE FIRST KNOT.THE OR TIME WAS PROLONGED DUE TO THIS. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15429227 ↗
• MalfunctionSep 15, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREAS PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN THE SURGEON TIED THE FIRST KNOT WHEN SUTURING A VESSEL. THE TRIED WITH 6 ADDITIONAL SUTURES FROM THE SAME LOT AND ALL OF THEM BROKE WHEN HE TIED THE FIRST KNOT. THE OR TIME WAS PROLONGED DUE TO THIS. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15429216 ↗
• MalfunctionSep 15, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREAS PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN THE SURGEON TIED THE FIRST KNOT WHEN SUTURING A VESSEL. THE TRIED WITH 6 ADDITIONAL SUTURES FROM THE SAME LOT AND ALL OF THEM BROKE WHEN HE TIED THE FIRST KNOT. THE OR TIME WAS PROLONGED DUE TO THIS. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15429173 ↗
• MalfunctionSep 15, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREAS PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN THE SURGEON TIED THE FIRST KNOT WHEN SUTURING A VESSEL. THE TRIED WITH 6 ADDITIONAL SUTURES FROM THE SAME LOT AND ALL OF THEM BROKE WHEN HE TIED THE FIRST KNOT. THE OR TIME WAS PROLONGED DUE TO THIS. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15429161 ↗
• MalfunctionSep 15, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREAS PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN THE SURGEON TIED THE FIRST KNOT WHEN SUTURING A VESSEL. THE TRIED WITH 6 ADDITIONAL SUTURES FROM THE SAME LOT AND ALL OF THEM BROKE WHEN HE TIED THE FIRST KNOT. THE OR TIME WAS PROLONGED DUE TO THIS. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15429125 ↗
• MalfunctionOct 2, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE IN 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10623589 ↗
• MalfunctionApr 30, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTRIC PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE BROKE DURING TISSUE PASSAGE. THERE WAS NO HARM TO PATIENT. THE SURGERY SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10016048 ↗
• MalfunctionApr 30, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTRIC PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE BROKE DURING TISSUE PASSAGE. THERE WAS NO HARM TO PATIENT. THE SURGERY SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10016046 ↗
• MalfunctionApr 30, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTRIC PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE BROKE DURING TISSUE PASSAGE. THERE WAS NO HARM TO PATIENT. THE SURGERY SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10016027 ↗
• MalfunctionApr 30, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTRIC PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE BROKE DURING TISSUE PASSAGE. THERE WAS NO HARM TO PATIENT. THE SURGERY SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10016005 ↗
• MalfunctionApr 30, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTRIC PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE BROKE DURING TISSUE PASSAGE. THERE WAS NO HARM TO PATIENT. THE SURGERY SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10016004 ↗
• MalfunctionSep 9, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE SEPARATED FROM THE SUTURE AND FELL INTO SITUS. IT REQUIRED SOME EFFORT TO RETRIEVE THE NEEDLE AND DELAY IN SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8976888 ↗
• MalfunctionJun 18, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2019 AND SUTURE WAS USED. THE NEEDLE SEPARATES FROM THE SUTURE DURING TISSUE PASSAGE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8709687 ↗
• MalfunctionJun 18, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2019 AND SUTURE WAS USED. THE NEEDLE SEPARATES FROM THE SUTURE DURING TISSUE PASSAGE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8709647 ↗
• MalfunctionJun 18, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2019 AND SUTURE WAS USED. THE NEEDLE SEPARATES FROM THE SUTURE DURING TISSUE PASSAGE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8709636 ↗
• MalfunctionJun 18, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CIRCUMCISION ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PARTIALLY BROKE OFF AND WAS TEMPORARILY RETAINED INSIDE THE PATIENTS PENIS. X-RAY WAS TAKEN. SUTURE NEEDLE WAS THEN REMOVED FROM THE PATIENT WITH GUIDED ULTRASOUND. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. IT IS UNKNOWN IF THERE WERE ANY ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8709093 ↗

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-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-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-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• 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-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-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631

…and 6 more.