PDS PDP149HRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10705031047938), received between Dec 27, 2021 and Sep 29, 2026 — classified as 3 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Break” (14 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932443 ↗
• MalfunctionSep 29, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932241 ↗
• MalfunctionSep 29, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932240 ↗
• MalfunctionSep 29, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932239 ↗
• MalfunctionSep 25, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902495 ↗
• MalfunctionSep 25, 2026Break

  It was reported that the patient underwent a tracheoplasty surgery in the hospital on (b)(6) 2026 and suture was used to sew the trachea in a continuous sewing manner during the operation. The intraoperative sewing operation was smooth, and no device failure or patient injury was reported. When the surgeon finished tying the knot and returned the remaining suture with the needle to the nurse, the nurse found that the needle at one end of the suture was missing. The surgeon immediately performed an intraoperative X-ray examination on the patient to locate the missing needle. No foreign body residue was found in the patient's body. Therefore, the surgeon continued the subsequent surgical operation. Medical staff continued to search for the missing needle and eventually found it on the floor of the operating room. After finding the needle, it was noted that the suture broke close to the needle attachment, causing the needle to fly off. This event resulted in additional radiation exposure to the patient and an extension of the procedure time (approximately 1 hour). The patient was in stable condition currently, and no subsequent adverse event report was received. Additional information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898026 ↗
• MalfunctionAug 18, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50298687 ↗
• MalfunctionAug 7, 2026Break

  It was reported that a patient underwent an unknown procedure in (b)(6) 2026 and suture was used. It was reported that total 4 products occurred suture breakage issue 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 50182049 ↗
• MalfunctionAug 7, 2026Break

  It was reported that a patient underwent an unknown procedure in (b)(6) 2026 and suture was used. It was reported that total 4 products occurred suture breakage issue 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 50182044 ↗
• MalfunctionAug 7, 2026Break

  It was reported that a patient underwent an unknown procedure in (b)(6) 2026 and suture was used. It was reported that total 4 products occurred suture breakage issue 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 50182040 ↗
• MalfunctionAug 6, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50165983 ↗
• MalfunctionNov 26, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. AN ANESTHESIOLOGIST USED SUTURE TO SUTURE SUBCUTANEOUS TISSUE IN POSTOPERATIVE PATIENTS, BUT DURING THE OPERATION, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. CONSIDERING THAT THIS SITUATION MAY AFFECT THE EFFICIENCY OF SUTURING AND THE QUALITY OF WOUND HEALING, THE PHYSICIAN IMMEDIATELY SUSPENDED THE USE OF THIS BATCH OF SUTURE AND REPLACED IT WITH ANOTHER TYPE OF SUTURE TO SUCCESSFULLY COMPLETE THE REMAINING SUTURING OPERATIONS. AFTER OBSERVATION AND CONFIRMATION, THE MALFUNCTION OF THE DEVICE DID NOT CAUSE TISSUE DAMAGE, FOREIGN BODY RESIDUE, OR ADVERSE EFFECTS ON OTHER TREATMENT PROCESSES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658331 ↗
• MalfunctionNov 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MINIMALLY INVASIVE FOREHEAD TUMOR RESECTION+SKIN FLAP REPAIR+COSMETIC SUTURE SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. AT 11:00, THE PATIENT UNDERWENT SURGERY. THE PLASTIC SURGEON USED A NEEDLE TO SUTURE THE SKIN, AND NO NEEDLE WAS FOUND MISSING DURING THE OPERATION. AFTER THE SKIN WAS SUTURED, THE DOCTOR ATTEMPTED TO RETURN THE NEEDLE TO THE CIRCUIT BOARD AND FOUND THAT THE NEEDLE WAS MISSING. AFTER REPORTING TO THE DUTY TEACHER, THE DOCTOR IMMEDIATELY SEARCHED FOR IT IN A STERILE VEHICLE, DRESSING, AND SURROUNDING ENVIRONMENT. HOWEVER, TO NO AVAIL, THE PATIENT WAS SENT OUT OF THE OPERATING ROOM AFTER CONFIRMATION THROUGH X-RAYS THAT IT WAS NOT IN THE PATIENT'S BODY. THERE IS A RISK OF FOREIGN OBJECTS REMAINING IN THE BODY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543735 ↗
• MalfunctionAug 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 FOUND THAT THE SUTURE WAS BROKEN WHILE USING IT. IMMEDIATELY REPLACED IT WITH A NEW SUTURE FOR USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22701265 ↗
• MalfunctionJul 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT¿S REPORTED THAT IT FOUND NEEDLE PULL OFF ISSUE DURING SEWING SUBCUTANEOUS SKIN IN THE INCISION OF LABIA MASS. THE NEEDLE FELL INTO PATIENT AND RETRIEVED TIMELY. 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 22646259 ↗
• MalfunctionJul 18, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HYPOSPADIAS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO PATIENT CONSEQUENCE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22540688 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NEVUS INCISION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED ON SUBCUTANEOUS TISSUE. THE PATIENT EXPERIENCED POOR POSTOPERATIVE HEALING. WHEN REMOVING THE STITCHES 10-14 DAYS AFTER SURGERY, THE PATIENT'S WOUND WAS NOT HEALED WELL WITH REDNESS AND SWELLING. RE-SEWING WAS DONE AFTER SKIN DISINFECTION. NOW THE PATIENT IS STABLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Impaired Healing; Scar Tissue; Swelling/ Edema

  MAUDE report 22344484 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NEVUS INCISION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED ON SUBCUTANEOUS TISSUE. THE PATIENT EXPERIENCED POOR POSTOPERATIVE HEALING. WHEN REMOVING THE STITCHES 10-14 DAYS AFTER SURGERY, THE PATIENT'S WOUND WAS NOT HEALED WELL WITH REDNESS AND SWELLING. RE-SEWING WAS DONE AFTER SKIN DISINFECTION. NOW THE PATIENT IS STABLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Impaired Healing; Scar Tissue; Swelling/ Edema

  MAUDE report 22344483 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NEVUS INCISION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED ON SUBCUTANEOUS TISSUE. THE PATIENT EXPERIENCED POOR POSTOPERATIVE HEALING. WHEN REMOVING THE STITCHES 10-14 DAYS AFTER SURGERY, THE PATIENT'S WOUND WAS NOT HEALED WELL WITH REDNESS AND SWELLING. RE-SEWING WAS DONE AFTER SKIN DISINFECTION. NOW THE PATIENT IS STABLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Impaired Healing; Scar Tissue; Swelling/ Edema

  MAUDE report 22344482 ↗
• MalfunctionMar 25, 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 FOUND THAT THE SUTURE WAS BROKEN WHILE USING IT, AND IT WAS IMMEDIATELY REPLACED FOR USE. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691685 ↗
• MalfunctionMar 25, 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 FOUND THAT THE SUTURE WAS BROKEN WHILE USING IT, AND IT WAS IMMEDIATELY REPLACED FOR USE. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21689330 ↗
• MalfunctionOct 16, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE TRAVELING NURSE REMOVED THE SUTURE ONTO THE STERILE INSTRUMENT TABLE AND FOUND THAT THE SUTURE WAS TAKEN OUT ALONG WITH THE OUTER PACKAGING. THE SURGEON CHECKED THE NEEDLE PLATE OF THE SUTURE AND FOUND THAT ONLY ABOUT 2CM OF SUTURE REMAINED ON THE NEEDLE. THE TOURING NURSE CHECKED THE SUTURE AND FOUND THAT THE ENDS OF THE SUTURE WERE TANGLED AND BROKEN. THE MOBILE NURSE IMMEDIATELY RETRIEVED THE SUTURE FROM THE SURGEON. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461638 ↗
• MalfunctionApr 18, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RENAL ALLOGENEIC TRANSPLANTATION+SURGERIES: DONOR KIDNEY REMOVAL+SURGERIES: KIDNEY REPAIR PROCEDURE TO SUTURE THE ILIAC ARTERY ON(B)(6) 2023; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE DOCTOR FOUND THAT THERE WAS NO NEEDLE AT THE END OF THE SUTURE. X-RAY CONFIRMED THAT THERE WERE NO FOREIGN OBJECT LEFT IN THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19135176 ↗
• MalfunctionMar 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY FOR A SKIN TUMOR REMOVAL ON (B)(6) 2023, AND SUTURE WAS USED. AFTER REMOVING THE TUMOR, THE DOCTOR FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, AND THE SUTURE WAS UNABLE TO BE USED WHILE SUTURING. IMMEDIATELY STOPPED USING AND REPLACED WITH A NEW SUTURE OF THE SAME ORIGIN, BATCH NUMBER, AND MODEL. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18902486 ↗
• MalfunctionOct 26, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A TUMOR RESECTION ON (B)(6) 2023 AND SUTURE WAS USED. AFTER REMOVING THE TUMOR, THE DOCTOR FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHILE SUTURING THE SKIN, MAKING IT UNUSABLE. IMMEDIATELY STOP USING AND REPLACE WITH A NEW SUTURE OF THE SAME ORIGIN, BATCH NUMBER, AND MODEL . NO REPORTED PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18010521 ↗