PROLENE 8720ZHRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705031465008), received between Jun 11, 2024 and Jun 15, 2026 — classified as 1 injury, 9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE CUSTOMER TO THE SALES REP THAT DURING AN UNKNOWN PROCEDURE, THAT THE NEEDLES KEPT POPPING OFF ON THE SUTURE. NO PATIENT CONSEQUENCES REPORTED. DEVICES ARE AVAILABLE TO RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25511296 ↗
• MalfunctionJun 15, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE CUSTOMER TO THE SALES REP THAT DURING AN UNKNOWN PROCEDURE, THAT THE NEEDLES KEPT POPPING OFF ON THE SUTURE. NO PATIENT CONSEQUENCES REPORTED. DEVICES ARE AVAILABLE TO RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25511289 ↗
• MalfunctionApr 22, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EMERGENCY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN EMERGENT TRIPLE A PROCEDURE, THE NEEDLE WAS POPPING OFF FROM THE SUTURE. THEY WERE ABLE TO RETRIEVE THE NEEDLE FROM THE PATIENT'S BODY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957125 ↗
• InjuryAug 5, 2025Break; Break

  IT WAS REPORTED TO THE SALES REP THAT, IT WAS REPORTED TO THE SALES REP THAT, DURING SURGERY, THE SURGEON WAS CLOSING THE RIGHT ATRIUM WHEN THE SUTURE POPPED OUT, CAUSING THE PATIENT TO BLEED OUT. IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE AND ROOT REPLACEMENT W/ RIGHT ATRIOTOMY ON (B)(6) 2025 DUE TO AORTIC ROOT ANEURYSM AND SUTURE WAS USED. THE SURGEON WAS CLOSING THE RIGHT ATRIUM WHEN THE SUTURE POPPED OUT, CAUSING THE PATIENT TO BLEED OUT. THE PATIENT WAS EXTUBATED AND HAD A NORMAL POST-OP, THEN HAD VOMITING, THEN BLEEDING OUT OF CHEST TUBES. SURGEON OPENED CHEST IN THE ICU AND REPAIRED RIGHT ATRIUM TO CONTROL THE BLEEDING. RETURN OF SPONTANEOUS CIRCULATION. THE PATIENT HAD A MASSIVE STROKE AND WAS SENT TO HOSPICE CARE EXPECTED TO DIE WITHIN WEEKS. COULD NOT TELL WHERE THE SUTURE WAS AT THE TIME OF REPAIR. DID NOT GET THE IMPRESSION THAT THE ATRIAL TISSUE TORE. SUTURE COULD HAVE BEEN SUCTIONED UP. NO TISSUE WEAKNESS OBSERVED. ADDITIONAL INFORMATION WAS REQUESTED. THE CAUSE OF DEATH WAS THAT THE PATIENT ARRESTED IN THE ICU DUE TO EXSANGUINATING HEMORRHAGE THAT HAPPENED AND THE PATIENT HAD SUDDEN BLEEDING OUT OF CHEST TUBES. THE SURGEON OPENED THE CHEST IN THE ICU, R

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Stroke/CVA; Vomiting

  MAUDE report 22710836 ↗
• MalfunctionJul 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE. THE NEEDLE WAS RECOVERED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22519828 ↗
• MalfunctionFeb 24, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR ANASTOMOSIS PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A VASCULAR ANASTOMOSIS THAT THREE SUTURES BROKE IN THE MIDDLE OF THE SUTURE WHILE DOING THE ANASTOMOSIS. A FOURTH DEVICE OF THE SAME LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO PRODUCT RETURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21447355 ↗
• MalfunctionFeb 24, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR ANASTOMOSIS PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A VASCULAR ANASTOMOSIS THAT THREE SUTURES BROKE IN THE MIDDLE OF THE SUTURE WHILE DOING THE ANASTOMOSIS. A FOURTH DEVICE OF THE SAME LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO PRODUCT RETURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21447353 ↗
• MalfunctionFeb 24, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR ANASTOMOSIS PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A VASCULAR ANASTOMOSIS THAT THREE SUTURES BROKE IN THE MIDDLE OF THE SUTURE WHILE DOING THE ANASTOMOSIS. A FOURTH DEVICE OF THE SAME LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO PRODUCT RETURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21447343 ↗
• MalfunctionJul 23, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. AFTER TYING THE SUTURE, THE NEEDLE WAS CLIPPED WITH SUTURE BOOTS. WHEN THE SURGEON WAS ABOUT TO USE THE CLIPPED NEEDLE, THE NEEDLE WAS FOUND MISSING. DURING THE SURGERY, THEY HAVE PERFORMED X-RAY AND THERE IS NO NEEDLE FOUND IN THE BODY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19806333 ↗
• MalfunctionJun 11, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A ATRIAL SEPTAL DEFECT ON (B)(6) 2024 AND SUTURE WAS USED. 5-0 SUTURE SNAP AT THE SWAGE AREA WHEN THE SURGEON IS DOING ASD PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19511405 ↗

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-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• 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-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• 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-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-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027

…and 6 more.