PROLENE HS6822HRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031232754), received between Nov 22, 2019 and Jan 30, 2026 — classified as 1 death, 10 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DOCTOR DISCOVERED IMPURITIES WHILE USING THE PRODUCT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24220534 ↗
• DeathMar 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFTING + MITRAL VALVULOPLASTY + TRICUSPID VALVULOPLASTY IN HOSPITAL ON (B)(6) 2024 DUE TO PALPITATION, CHEST TIGHTNESS, SHORTNESS OF BREATH AND HEART FAILURE AND SUTURE WAS USED FOR SEWING THE SUPERIOR AND INFERIOR VENA CAVA IN A CONTINUOUS SUTURING MANNER. PULL OFF SUTURE NEEDLE ISSUE OCCURRED DURING THE SURGERY. THE DETACHED NEEDLE WAS REMOVED FROM THE PATIENT. THE SURGEON IMMEDIATELY REPLACED A NEW SUTURE PRODUCT TO CONTINUE THE SEWING. THE SUBSEQUENT SURGERY WENT SMOOTHLY. LATER, THE PATIENT'S HEART COULD NOT REBOUND, AND THE SURGEON IMMEDIATELY PERFORMED RESCUE. THE PATIENT DIED ON (B)(6) 2024. AFTER CONTACTING THE HOSPITAL, THE HOSPITAL FEEDBACK THAT THE PATIENT HAD POOR HEART, POOR PHYSICAL FITNESS, POOR CARDIAC FUNCTION AND VASCULAR STENOSIS. THE PHYSICIAN CONSIDERED THAT THE CAUSE OF DEATH WAS PATIENT'S PHYSICAL CONDITION (71-YEAR-OLD PATIENT WITH POOR CARDIOPULMONARY FUNCTION), NOT RELATED TO OUR SUTURE PRODUCTS. ACCORDING TO THE INFORMATION CURRENTLY AVAILABLE, THE CAUSE OF THIS DEATH EVENT COULD NOT BE CONFIRMED, AND THE CORRELATION WITH THE SUTURE PRODUCTS WAS VERY SMALL ACCORDING TO OUR LOCAL MEDICAL AF

  Patient problems: Insufficient Information

  MAUDE report 18927449 ↗
• MalfunctionJan 23, 2024Break; Break

  IT WAS REPORTED THAT A 72 YEAR MALE PATIENT UNDERWENT AN FET (FROZEN ELEPHANT TRUNK) AND CABG PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE PATIENT HAD BEEN DIAGNOSED WITH AORTIC ARCH ANEURYSM WITH AM DISSECTION AND SINGLE VESSEL DISEASE. WHEN THE SURGEON IS PERFORMING THE PROCEDURE, DURING THE ANASTOMOSIS, THE SUTURE SNAPPED DURING SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18565525 ↗
• MalfunctionMay 19, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN LEFT HEMI HEPATECTOMY PROCEDURE (B)(6)2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN OPEN LEFT HEMI HEPATECTOMY SURGERY. CHANGED ANOTHER FOUR TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16962098 ↗
• MalfunctionMay 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN LEFT HEMI HEPATECTOMY PROCEDURE (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN OPEN LEFT HEMI HEPATECTOMY SURGERY. CHANGED ANOTHER FOUR TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16959003 ↗
• MalfunctionMay 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN LEFT HEMI HEPATECTOMY PROCEDURE (B)(6)2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN OPEN LEFT HEMI HEPATECTOMY SURGERY. CHANGED ANOTHER FOUR TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16959002 ↗
• MalfunctionMay 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN LEFT HEMI HEPATECTOMY PROCEDURE (B)(6)2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN OPEN LEFT HEMI HEPATECTOMY SURGERY. CHANGED ANOTHER FOUR TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16959000 ↗
• MalfunctionApr 10, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG WITH AVR PROCEDURE ON 3/16/2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. DURING THE VALVE REPLACEMENT WHEN SECURING THE VALVE INTO THE AORTA THAT THE 3-0 SUTURE SNAPPED WHILE SECURING THE KNOT AND WHILE ATTACHING THE HARVESTED VEIN TO THE HEART THE 5-0 SUTURE SNAPPED WHILE TYING THE KNOT. A SECOND SUTURE WAS USED TO COMPLETE EACH PORTION OF THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709417 ↗
• MalfunctionSep 17, 2020Break; Break

  THE EVENT WAS NOT REPORTED. HOWEVER, THE SUTURE PRODUCT WAS RECEIVED WITHOUT ANY DETAILS OF EVENT. UPON EVALUATION, THE SUTURE OBSERVED DAMAGED AND POSSIBLY CUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10549169 ↗
• MalfunctionAug 25, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TENDON REPAIR PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHILE SEWING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10449732 ↗
• MalfunctionNov 22, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING SUTURING. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9363201 ↗

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-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981

…and 6 more.