PROLENE 8528HRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031091108), received between Oct 22, 2020 and Oct 22, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARDIAC SURGERY ON (B)(6) 2020, AND THE SUTURE WAS USED. DURING INSTALLATION OF THE HEART WARE, A FRAGILITY OF SUTURE, WHICH BREAKS AT A LOW TENSION THRESHOLD, WAS NOTED. THE SUTURE BROKE WITHOUT EXERTING EXCESSIVE TENSION. ANOTHER LIKE SUTURE BOX FROM THE SAME BATCH WAS OPENED TO FINISH THE PROCEDURE WITHOUT PROBLEM. THERE WERE NO CLINICAL CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10717239 ↗
• MalfunctionOct 22, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARDIAC SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING INSTALLATION OF HEART WARE, A FRAGILITY OF SUTURE WHICH BREAK AT A LOW TENSION THRESHOLD WAS NOTED. THE SUTURE BROKE WITHOUT EXERTING EXCESSIVE TENSION. ANOTHER LIKE SUTURE BOX FROM THE SAME BATCH WAS OPENED TO FINISH THE PROCEDURE WITHOUT PROBLEM. THERE WERE NO CLINICAL CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10717237 ↗
• MalfunctionOct 22, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARDIAC SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING INSTALLATION OF HEART WARE, A FRAGILITY OF SUTURE WHICH BREAK AT A LOW TENSION THRESHOLD WAS NOTED. THE SUTURE BROKE WITHOUT EXERTING EXCESSIVE TENSION. ANOTHER LIKE SUTURE BOX FROM THE SAME BATCH WAS OPENED TO FINISH THE PROCEDURE WITHOUT PROBLEM. THERE WERE NO CLINICAL CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10717236 ↗
• MalfunctionOct 22, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARDIAC SURGERY ON (B)(6) 2020, AND THE SUTURE WAS USED. DURING INSTALLATION OF HEART WARE, A FRAGILITY OF SUTURE WHICH BREAK AT A LOW TENSION THRESHOLD WAS NOTED. THE SUTURE BROKE WITHOUT EXERTING EXCESSIVE TENSION. ANOTHER LIKE SUTURE BOX FROM THE SAME BATCH WAS OPENED TO FINISH THE PROCEDURE WITHOUT PROBLEM. THERE WERE NO CLINICAL CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10717228 ↗
• MalfunctionOct 22, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARDIAC SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING INSTALLATION OF HEART WARE, A FRAGILITY OF SUTURE WHICH BREAK AT A LOW TENSION THRESHOLD WAS NOTED. THE SUTURE BROKE WITHOUT EXERTING EXCESSIVE TENSION. ANOTHER LIKE SUTURE BOX FROM THE SAME BATCH WAS OPENED TO FINISH THE PROCEDURE WITHOUT PROBLEM. THERE WERE NO CLINICAL CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10717226 ↗
• MalfunctionOct 22, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARDIAC SURGERY ON (B)(6) 2020, AND THE SUTURE WAS USED. DURING INSTALLATION OF HEART WARE, A FRAGILITY OF SUTURE, WHICH BREAK AT A LOW TENSION THRESHOLD WAS NOTED. THE SUTURE BROKE WITHOUT EXERTING EXCESSIVE TENSION. ANOTHER LIKE SUTURE BOX FROM THE SAME BATCH WAS OPENED TO FINISH THE PROCEDURE WITHOUT PROBLEM. THERE WERE NO CLINICAL CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10717225 ↗

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-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• 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-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981

…and 6 more.