PROLENE EH7920HRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031098527), received between Sep 7, 2023 and Sep 15, 2023 — classified as 1 injury, 3 malfunctions.

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

• MalfunctionSep 15, 2023Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST OPERATVELY, IN THE EMERGENCY ROOM ON THE FOURTH FLOOR, THE THREAD USED TO CLOSE THE SKIN WAS EITHER TORN OR THEY WERE TORN DURING THE DISINFECTION OF THE SKIN, OR THE KNOT. THE DOCTOR OPINES THAT THIS IS NOT A ONE-OFF CASE, AND ESPECIALLY NOT DUE TO A SURGEON'S TECHNICAL ERROR. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17754740 ↗
• MalfunctionSep 15, 2023Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST OPERATVELY, IN THE EMERGENCY ROOM ON THE FOURTH FLOOR, THE THREAD USED TO CLOSE THE SKIN WAS EITHER TORN OR THEY WERE TORN DURING THE DISINFECTION OF THE SKIN, OR THE KNOT. THE DOCTOR OPINES THAT THIS IS NOT A ONE-OFF CASE, AND ESPECIALLY NOT DUE TO A SURGEON'S TECHNICAL ERROR. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17754739 ↗
• MalfunctionSep 15, 2023Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST OPERATIVELY, IN THE EMERGENCY ROOM ON THE FOURTH FLOOR, THE THREAD USED TO CLOSE THE SKIN WAS EITHER TORN OR THEY WERE TORN DURING THE DISINFECTION OF THE SKIN, OR THE KNOT. THE DOCTOR OPINES THAT THIS IS NOT A ONE-OFF CASE, AND ESPECIALLY NOT DUE TO A SURGEON'S TECHNICAL ERROR. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17754738 ↗
• InjurySep 7, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST OPERATIVELY, IN THE EMERGENCY ROOM ON THE FOURTH FLOOR, THAT THE PATIENT CAME IN FOR SUTURE REMOVAL AND THERE WERE NO LONGER STITCHES IN HIS BACK, WHICH WERE REMOVED DURING BANDAGING AT HOME AND UNINTENTIONALLY, THE KNOT BROKE. THE DOCTOR OPINES THAT THIS IS NOT A ONE-OFF CASE, AND ESPECIALLY NOT DUE TO A SURGEON'S TECHNICAL ERROR. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Wound Dehiscence

  MAUDE report 17706958 ↗

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-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• 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-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• 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-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768

…and 6 more.