PROLENE 9702HRecalls & reported problems

Summary

The FDA's MAUDE database contains 130 adverse event reports that list this exact device (DI 10705031022867), received between May 10, 2018 and Aug 28, 2026 — classified as 4 injuries, 126 malfunctions.

The most frequently reported specific device problem is “Material Separation” (93 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 25 most recent of 130 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2026Break

  Patient problems: Foreign Body In Patient; Heart Failure/Congestive Heart Failure

  MAUDE report 50500054 ↗
• MalfunctionApr 11, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT TOTAL 3 PRODUCTS OCCURRED THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THE 3 ACTUAL SAMPLE WAS DISCARDED. THE SURGEON REFUSED TO USE THE REMAINING 11 STERILE PRODUCTS FROM THE SAME LOT AND THEY WILL BE RETURNED FOR ANALYSIS. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24846057 ↗
• MalfunctionApr 11, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT TOTAL 3 PRODUCTS OCCURRED THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THE 3 ACTUAL SAMPLE WAS DISCARDED. THE SURGEON REFUSED TO USE THE REMAINING 11 STERILE PRODUCTS FROM THE SAME LOT AND THEY WILL BE RETURNED FOR ANALYSIS. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845983 ↗
• MalfunctionApr 10, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT TOTAL 3 PRODUCTS OCCURRED THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THE 3 ACTUAL SAMPLE WAS DISCARDED. THE SURGEON REFUSED TO USE THE REMAINING 11 STERILE PRODUCTS FROM THE SAME LOT AND THEY WILL BE RETURNED FOR ANALYSIS. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24840077 ↗
• MalfunctionFeb 9, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP BY THE SURGEON THAT BROKE WHILE SUTURING DURING PROCEDURE. ALL PIECES RETAINED FROM PATIENT AND ACCOUNTED FOR. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ONE DEVICE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293750 ↗
• MalfunctionNov 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED VASCULAR PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE HAS BROKEN OFF THE NEEDLE AT THE SWAGE. NORMAL FORCE WAS APPLIED WORKING THROUGH TRADITIONAL BLOOD VESSELS. NO CONSEQUENCES OBSERVED, BUT SURGEON IS CONCERNED. NO EACHES USED ARE AVAILABLE TO BE RETURNED. NO SURGICAL DELAY OR GENERATED FRAGMENTS WERE REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649412 ↗
• MalfunctionNov 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED VASCULAR PROCEDURE IN 2025 AND SUTURE WAS USED. THE SUTURE HAS BROKEN OFF THE NEEDLE AT THE SWAGE. NORMAL FORCE WAS APPLIED WORKING THROUGH TRADITIONAL BLOOD VESSELS. NO CONSEQUENCES OBSERVED, BUT SURGEON IS CONCERNED. NO EACHES USED ARE AVAILABLE TO BE RETURNED. NO SURGICAL DELAY OR GENERATED FRAGMENTS WERE REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647253 ↗
• MalfunctionNov 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED VASCULAR PROCEDURE IN 2025 AND SUTURE WAS USED. THE SUTURE HAS BROKEN OFF THE NEEDLE AT THE SWAGE. NORMAL FORCE WAS APPLIED WORKING THROUGH TRADITIONAL BLOOD VESSELS. NO CONSEQUENCES OBSERVED, BUT SURGEON IS CONCERNED. NO EACHES USED ARE AVAILABLE TO BE RETURNED. NO SURGICAL DELAY OR GENERATED FRAGMENTS WERE REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647252 ↗
• MalfunctionNov 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED VASCULAR PROCEDURE IN 2025 AND SUTURE WAS USED. THE SUTURE HAS BROKEN OFF THE NEEDLE AT THE SWAGE. NORMAL FORCE WAS APPLIED WORKING THROUGH TRADITIONAL BLOOD VESSELS. NO CONSEQUENCES OBSERVED, BUT SURGEON IS CONCERNED. NO EACHES USED ARE AVAILABLE TO BE RETURNED. NO SURGICAL DELAY OR GENERATED FRAGMENTS WERE REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647250 ↗
• MalfunctionNov 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED VASCULAR PROCEDURE IN 2025 AND SUTURE WAS USED. THE SUTURE HAS BROKEN OFF THE NEEDLE AT THE SWAGE. NORMAL FORCE WAS APPLIED WORKING THROUGH TRADITIONAL BLOOD VESSELS. NO CONSEQUENCES OBSERVED, BUT SURGEON IS CONCERNED. NO EACHES USED ARE AVAILABLE TO BE RETURNED. NO SURGICAL DELAY OR GENERATED FRAGMENTS WERE REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647248 ↗
• MalfunctionNov 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED VASCULAR PROCEDURE IN 2025 AND SUTURE WAS USED. THE SUTURE HAS BROKEN OFF THE NEEDLE AT THE SWAGE. NORMAL FORCE WAS APPLIED WORKING THROUGH TRADITIONAL BLOOD VESSELS. NO CONSEQUENCES OBSERVED, BUT SURGEON IS CONCERNED. NO EACHES USED ARE AVAILABLE TO BE RETURNED. NO SURGICAL DELAY OR GENERATED FRAGMENTS WERE REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647240 ↗
• MalfunctionNov 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED VASCULAR PROCEDURE IN 2025 AND SUTURE WAS USED. THE SUTURE HAS BROKEN OFF THE NEEDLE AT THE SWAGE. NORMAL FORCE WAS APPLIED WORKING THROUGH TRADITIONAL BLOOD VESSELS. NO CONSEQUENCES OBSERVED, BUT SURGEON IS CONCERNED. NO EACH USED ARE AVAILABLE TO BE RETURNED. NO SURGICAL DELAY OR GENERATED FRAGMENTS WERE REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647117 ↗
• MalfunctionNov 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED VASCULAR PROCEDURE IN 2025 AND SUTURE WAS USED. THE SUTURE HAS BROKEN OFF THE NEEDLE AT THE SWAGE. NORMAL FORCE WAS APPLIED WORKING THROUGH TRADITIONAL BLOOD VESSELS. NO CONSEQUENCES OBSERVED, BUT SURGEON IS CONCERNED. NO EACH USED ARE AVAILABLE TO BE RETURNED. NO SURGICAL DELAY OR GENERATED FRAGMENTS WERE REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647068 ↗
• MalfunctionNov 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED VASCULAR PROCEDURE IN 2025 AND SUTURE WAS USED. THE SUTURE HAS BROKEN OFF THE NEEDLE AT THE SWAGE. NORMAL FORCE WAS APPLIED WORKING THROUGH TRADITIONAL BLOOD VESSELS. NO CONSEQUENCES OBSERVED, BUT SURGEON IS CONCERNED. NO EACHES USED ARE AVAILABLE TO BE RETURNED. NO SURGICAL DELAY OR GENERATED FRAGMENTS WERE REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647056 ↗
• MalfunctionNov 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED VASCULAR PROCEDURE IN 2025 AND SUTURE WAS USED. THE SUTURE HAS BROKEN OFF THE NEEDLE AT THE SWAGE. NORMAL FORCE WAS APPLIED WORKING THROUGH TRADITIONAL BLOOD VESSELS. NO CONSEQUENCES OBSERVED, BUT SURGEON IS CONCERNED. NO EACH USED ARE AVAILABLE TO BE RETURNED. NO SURGICAL DELAY OR GENERATED FRAGMENTS WERE REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647024 ↗
• MalfunctionOct 20, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE CAME OUT FRAYED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337159 ↗
• MalfunctionOct 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT, THE SUTURE KEEP POOPING OF FROM THE SWAGE THIS HAPPEN 2-3 TIMES THEY USED ANOTHER LOT NUMBER AND IT WAS FINE. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303666 ↗
• MalfunctionOct 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT, THE SUTURE KEEP POOPING OF FROM THE SWAGE THIS HAPPEN 2-3 TIMES THEY USED ANOTHER LOT NUMBER AND IT WAS FINE. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303414 ↗
• MalfunctionOct 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT, THE SUTURE KEEP POOPING OF FROM THE SWAGE THIS HAPPEN 2-3 TIMES THEY USED ANOTHER LOT NUMBER AND IT WAS FINE. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302616 ↗
• MalfunctionJul 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE DOCTOR EXPERIENCED SUTURE STRING DETACHING FROM THE NEEDLE. HE CHANGED NEEDLES A COUPLE OF TIMES BUT ENCOUNTERED THE SAME ISSUE. SURGICAL DELAY UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554732 ↗
• MalfunctionJul 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE DOCTOR EXPERIENCED SUTURE STRING DETACHING FROM THE NEEDLE. HE CHANGED NEEDLES A COUPLE OF TIMES BUT ENCOUNTERED THE SAME ISSUE. SURGICAL DELAY UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554688 ↗
• MalfunctionApr 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL SEPTAL DEFECT REPAIR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT'S REPORTED THAT THE NEEDLE WAS FOUND DETACHED FROM SUTURE AND IT FELL INTO HEART DURING OPERATION. THE SURGERY PROLONGED OVER 30 MINUTES AND THE NEEDLE WAS FOUND AND RETRIEVED FROM PATIENT. AT THIS MOMENT THE PATIENT IS NORMAL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866652 ↗
• MalfunctionNov 4, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE NEEDLE WAS DISASSEMBLED FROM THE THREAD. THE SURGERY WAS DELAYED 5 MINUTES DUE TO THE REPORTED EVENT. A NEW SUTURE WAS USED WHEN THE EVENT OCCURRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND FRAGMENTS WERE NOT GENERATED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20604768 ↗
• MalfunctionSep 27, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PROLINE SUTURE, NEEDLE BREAKING OFF. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20321848 ↗
• MalfunctionSep 27, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PROLINE SUTURE, NEEDLE BREAKING OFF. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20321615 ↗

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-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• 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-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748

…and 6 more.