PDS Z148HRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10705031060272), received between Sep 6, 2019 and Feb 5, 2026 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Material Separation” (13 reports).

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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026Material Separation

  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 THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. 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 24269940 ↗
• MalfunctionDec 30, 2025Material Separation; Material Separation

  IT WAS REPORTED FROM THE ANALYSIS OF THE RETURNED PRODUCT THAT SUTURE DEGRADATION AND HOLE IN CAVITY WAS OBSERVED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN THE SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23923981 ↗
• InjuryDec 17, 2025Failure to Degrade; Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. POST-OP, AFTER SURGERY, THE SUTURE WAS NOT ABSORBED AND THE SUBCUTANEOUS SUTURE OF THE WOUND WAS EXPOSED. AFTER DISINFECTION BY THE DOCTOR, THE SUTURE WAS REMOVED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Wound Dehiscence

  MAUDE report 23827379 ↗
• MalfunctionSep 3, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. TOTAL 3 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ENCLOSED PLEASE FIND DEFECT PHOTOS. 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 22952703 ↗
• MalfunctionSep 3, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. TOTAL 3 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ENCLOSED PLEASE FIND DEFECT PHOTOS. 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 22952698 ↗
• MalfunctionSep 3, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. TOTAL 3 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ENCLOSED PLEASE FIND DEFECT PHOTOS. 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 22952696 ↗
• MalfunctionAug 26, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHEN SUTURING SKIN. CHANGED ANOTHER ONE TO CONTINUE THE BREAST SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ENCLOSED PLEASE FIND DEFECT PHOTO. 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 22897943 ↗
• MalfunctionAug 26, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHEN SUTURING SKIN. CHANGED ANOTHER ONE TO CONTINUE THE BREAST SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ENCLOSED PLEASE FIND DEFECT PHOTO. 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 22897934 ↗
• MalfunctionAug 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT TOTAL 2 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882759 ↗
• MalfunctionAug 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT TOTAL 2 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882755 ↗
• MalfunctionJan 9, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18477707 ↗
• MalfunctionDec 6, 2023Material Separation; Material Separation

  IT WAS REPORTED FROM THE ANALYSIS OF THE RETURNED PRODUCT THAT SUTURE DEGRADATION WAS OBSERVED. IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2023 AND A SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR THE SURGERY. THE SURGEON REFUSED TO USE THE REMAINING 6 STERILE PRODUCTS. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18276255 ↗
• MalfunctionMar 14, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR DISCECTOMY PROCEDURE ON (B)(6) 2023 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 16542532 ↗
• MalfunctionFeb 16, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED 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 16390831 ↗
• MalfunctionJan 6, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED FOR WOUND CLOSURE. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE, CAUSING THE NEEDLE TO BE MISSING. WHEN THE NEEDLE WAS FOUND MISSING, THE DOCTOR IMMEDIATELY STOPPED CLOSING THE ABDOMEN TO FIND THE BROKEN NEEDLE, AND THE OPERATOR TOOK CORRESPONDING MEASURES TO USE X-RAY POWER OFF FLUOROSCOPY. THE OPERATING ROOM INCLUDED THE ABDOMINAL CAVITY TO FIND THE BROKEN NEEDLE, BUT IT WAS NOT FOUND. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16112571 ↗
• MalfunctionNov 4, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE BROKE WHEN THE LEFT SIDE OF THE PATIENT'S INFUSION HOSE WAS REPAIRED, AND PLASTIC WAS SUTURED. IT WAS IMMEDIATELY TAKEN OUT OF THE ABDOMINAL CAVITY. THE DOCTOR PULLED THE SUTURE SLIGHTLY, AND THE SUTURE BROKE INTO SEVERAL SECTIONS. CHANGED TO ANOTHER ONE IN ORDER TO COMPLETE THE SURGERY NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15738696 ↗
• MalfunctionOct 6, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CLEFT LIP AND PALATE PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF OF THE SUTURE WHILING SEWING UPPER LIP AT THE SECOND STITCH. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12584852 ↗
• MalfunctionSep 6, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE WHEN SEWING DURING THE SURGERY. THE BROKEN RESIDUAL SUTURE WAS REMOVED. CHANGED TO ANOTHER LIKE DEVICE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8972600 ↗