PDS Z149HRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10705031060289), received between Jun 4, 2019 and Feb 6, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Break” (12 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 10, 2024Open, Classified

   Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

   Z-2146-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHEN SEWING DURING THE SURGERY. THE NEEDLE DID NOT FALL INTO THE PATIENT. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24281068 ↗
• MalfunctionDec 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EAR, NOSE & THROAT PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED DURING THE SURGERY. THE NEEDLE DID NOT FALL INTO THE PATIENT. THE LOT OF IP IS UNAVAILABLE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821266 ↗
• MalfunctionDec 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EAR, NOSE & THROAT PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED DURING THE SURGERY. THE NEEDLE DID NOT FALL INTO THE PATIENT. THE LOT NUMBER IS UNAVAILABLE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821201 ↗
• MalfunctionJun 4, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER TWO TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THE 3 ACTUAL SAMPLES WERE DISCARD. THE SURGEON REFUSED TO USE THE REMAINING 30 STERILE PRODUCTS FROM THE SAME LOT AND THEY WILL BE RETURNED FOR ANALYSIS. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140666 ↗
• MalfunctionJun 4, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER TWO TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THE 3 ACTUAL SAMPLES WERE DISCARD. THE SURGEON REFUSED TO USE THE REMAINING 30 STERILE PRODUCTS FROM THE SAME LOT AND THEY WILL BE RETURNED FOR ANALYSIS. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140661 ↗
• MalfunctionJun 4, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER TWO TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THE 3 ACTUAL SAMPLES WERE DISCARD. THE SURGEON REFUSED TO USE THE REMAINING 30 STERILE PRODUCTS FROM THE SAME LOT AND THEY WILL BE RETURNED FOR ANALYSIS. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140660 ↗
• MalfunctionMar 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL RESECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT UNDERWENT SURGICAL RESECTION AT 08:00 DUE TO A SUBCUTANEOUS CYST ON THE LEFT FACE. AFTER THE CYST WAS REMOVED, DURING SUTURING THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. THE SUTURE WAS CHANGED AND SUTURED AGAIN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21655094 ↗
• MalfunctionDec 3, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KIDNEY TRANSPLANT PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP WHO WAS IN THE CASE THAT DURING A KIDNEY TRANSPLANT PROCEDURE THAT SURGEON OPENED TWO PACKS OF SUTURE AND FELT THAT THE WRONG NEEDLE WAS ON THE SUTURE. A THIRD PACK WAS OPENED TO CONTINUE WITH THE PROCEDURE. NO DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833983 ↗
• MalfunctionDec 3, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KIDNEY TRANSPLANT PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP WHO WAS IN THE CASE THAT DURING A KIDNEY TRANSPLANT PROCEDURE THAT SURGEON OPENED TWO PACKS OF SUTURE AND FELT THAT THE WRONG NEEDLE WAS ON THE SUTURE. A THIRD PACK WAS OPENED TO CONTINUE WITH THE PROCEDURE. NO DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833974 ↗
• MalfunctionNov 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FACIAL PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING THE PATIENT'S FACIAL WOUND, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHILE USING A NEEDLE HOLDER TO CLAMP THE NEEDLE FROM THE NEEDLE ROW. CHANGED ANOTHER SUTURE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675452 ↗
• MalfunctionSep 17, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237965 ↗
• MalfunctionSep 17, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237869 ↗
• MalfunctionJul 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THYROIDECTOMY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED TO 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 19742434 ↗
• MalfunctionDec 6, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREATODUODENECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18275720 ↗
• MalfunctionDec 6, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREATODUODENECTOMY PROCEDURE ON 06-NOV-2023 AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18275612 ↗
• MalfunctionNov 22, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREATODUODENECTOMY ON 27-OCT-2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN WITH USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18191783 ↗
• MalfunctionAug 29, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REPAIR OF HYPOSPADIAS PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. AT 14:30, THE PATIENT UNDERWENT SURGERY WITH STABLE VITAL SIGNS DURING THE SURGERY. AT APPROXIMATELY 15:30, THE DOCTOR SUTURED THE PATIENT WITH SUTURE. UNDER NORMAL OPERATION WITHOUT PULLING, THE SUTURE BROKE, CAUSING THE NEEDLE TO FALL. THE PATIENT IMMEDIATELY SEARCHED FOR AND RE-OPENED THE NEEDLE TO CONTINUE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17640931 ↗
• MalfunctionDec 13, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE BROKE WHEN SEWING IN SURGERY. 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 15974527 ↗
• MalfunctionOct 18, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREATIC HEAD TUMOR RESECTION SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE SEWING THE PANCREATIC DUCT, THE SUTURE NEEDLE PULLED OFF. THE INSIDE OF THE ABDOMINAL CAVITY WAS CHECKED, AND THE NEEDLE WAS FOUND. IT WAS REMOVED AND SUTURE WAS REPERFORMED WITH ANOTHER NEEDLE-SUTURE NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647544 ↗
• MalfunctionSep 13, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PANCREATODUODENECTOMY ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE-SUTURE WAS USED FOR PANCREATICOJEJUNOSTOMY BY INTERRUPTED SUTURING, BUT THE SUTURE WAS BROKEN WHILE TYING A KNOT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9038434 ↗
• MalfunctionSep 13, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PANCREATODUODENECTOMY ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE-SUTURE WAS USED FOR PANCREATICOJEJUNOSTOMY BY INTERRUPTED SUTURING, BUT THE SUTURE WAS BROKEN WHILE TYING A KNOT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9038324 ↗
• MalfunctionAug 19, 2019Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A ENUCLEATION OF TESTICULAR TUMORS ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE PULLED OFF OF THE SUTURE DURING USE. CHANGED TO ANOTHER SUTURE TO COMPLETE SURGERY. THERE IS NO REPORT ON PATIENT CONSEQUENCE. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8906867 ↗
• MalfunctionAug 19, 2019Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A PENILE FLAP PLASY ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE PULLED OFF THE SUTURE AFTER THE NEEDLE PIERCED THROUGH THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE SURGERY. THERE IS NO REPORTED ON PATIENT CONSEQUENCE. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8906015 ↗
• MalfunctionJun 4, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARDIAC PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE PULLED OFF THE SUTURE DURING USE. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8668571 ↗
• MalfunctionJun 4, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CARDIAC PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE PULLED OFF FROM THE SUTURE DURING USE. THE FALLEN PIECE WAS RETRIEVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8668157 ↗