PROLENE 8800HRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031020610), received between Feb 13, 2025 and Aug 13, 2025 — classified as 4 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.

• MalfunctionAug 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE CUSTOMER CAME ACROSS SOME SUTURES THAT WERE UNUSABLE IN THEATRE TODAY. THE SCRUB TEAM STATED THAT WHEN ROLLING THE NEEDLE OUT TO ARM THE NEEDLE HOLDER, THE THREAD WAS TANGLED AND BROKE, ALONG WITH THE NEEDLE. THIS HAPPENED WITH THREE SUTURES, ALL FROM THE SAME BOX AND BATCH NUMBER. CUSTOMER HAS REMOVED ANY EXISTING STOCK FROM THEIR STORES. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22793191 ↗
• MalfunctionAug 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE CUSTOMER CAME ACROSS SOME SUTURES THAT WERE UNUSABLE IN THEATRE TODAY. THE SCRUB TEAM STATED THAT WHEN ROLLING THE NEEDLE OUT TO ARM THE NEEDLE HOLDER, THE THREAD WAS TANGLED AND BROKE, ALONG WITH THE NEEDLE. THIS HAPPENED WITH THREE SUTURES, ALL FROM THE SAME BOX AND BATCH NUMBER. CUSTOMER HAS REMOVED ANY EXISTING STOCK FROM THEIR STORES. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22793187 ↗
• MalfunctionAug 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE CUSTOMER CAME ACROSS SOME SUTURES THAT WERE UNUSABLE IN THEATRE TODAY. THE SCRUB TEAM STATED THAT WHEN ROLLING THE NEEDLE OUT TO ARM THE NEEDLE HOLDER, THE THREAD WAS TANGLED AND BROKE, ALONG WITH THE NEEDLE. THIS HAPPENED WITH THREE SUTURES, ALL FROM THE SAME BOX AND BATCH NUMBER. CUSTOMER HAS REMOVED ANY EXISTING STOCK FROM THEIR STORES. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22793186 ↗
• MalfunctionFeb 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE RUPTURED. THE ISSUE HAS REPORTED BUT THE DETAILS ARE UNKNOWN AT THIS TIME, SO IT IS BEING CONFIRMED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21376880 ↗

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-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-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• 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-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• 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
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844

…and 6 more.