PDS D7725Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705031028333), received between Sep 16, 2019 and Dec 30, 2024 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY AND COULD NOT BE USED. WHEN ANOTHER LOT WAS USED, IT COULD BE USED NORMALLY. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21036929 ↗
• MalfunctionDec 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY AND COULD NOT BE USED. WHEN ANOTHER LOT WAS USED, IT COULD BE USED NORMALLY. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21036928 ↗
• MalfunctionOct 28, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN NEUROSURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE TENSION WAS WEAK THAN USUAL AND EASY TO BREAK. IT WAS A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20553317 ↗
• MalfunctionOct 28, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN NEUROSURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE TENSION WAS WEAK THAN USUAL AND EASY TO BREAK. IT WAS A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20553310 ↗
• MalfunctionOct 28, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN NEUROSURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE TENSION WAS WEAK THAN USUAL AND EASY TO BREAK. IT WAS A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20553302 ↗
• MalfunctionOct 28, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN NEUROSURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE TENSION WAS WEAK THAN USUAL AND EASY TO BREAK. IT WAS A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20553065 ↗
• MalfunctionOct 28, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN NEUROSURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE TENSION WAS WEAK THAN USUAL AND EASY TO BREAK. IT WAS A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20552269 ↗
• MalfunctionOct 28, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN NEUROSURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE TENSION WAS WEAK THAN USUAL AND EASY TO BREAK. IT WAS A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20552265 ↗
• MalfunctionOct 28, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN NEUROSURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE TENSION WAS WEAK THAN USUAL AND EASY TO BREAK. IT WAS A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20552126 ↗
• MalfunctionOct 28, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN NEUROSURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE TENSION WAS WEAK THAN USUAL AND EASY TO BREAK. IT WAS A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20550624 ↗
• MalfunctionJul 16, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN SUTURING, IT WAS IMMEDIATELY DETACHED. IT WAS A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19748773 ↗
• MalfunctionDec 28, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE THE NEEDLE WAS BROKEN AT SWAGE PART. NO NEEDLE FELL INTO THE BODY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18413242 ↗
• MalfunctionJun 13, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE UNKNOWN SURGERY, AFTER OPENING THE PACKAGE AND BEFORE USE, IT WAS FOUND THAT THERE WAS A FOREIGN SUBSTANCE LIKE HUMAN HAIR IN THE STERILE PACKAGE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17119163 ↗
• MalfunctionAug 24, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 07/29/2022 AND SUTURE WAS USED. THE NEEDLE BROKE DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15283793 ↗
• MalfunctionSep 21, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VATS PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE AT THE SWAGE PART WHILE BEING USED ON THE DERMIS. THE BROKEN NEEDLE WAS LOST TEMPORARILY, BUT FOUND. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12507795 ↗
• MalfunctionOct 16, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CRANIOTOMY PROCEDURE (B)(6) 2020, AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON WAS PASSING THE NEEDLE THROUGH THE TISSUE BY INTERRUPTED SUTURING, HE HAD UNUSUAL FEELING. SO, WHEN CHECKING THE NEEDLE, IT WAS FOUND THAT THE NEEDLE HAD BEEN BROKEN AT THE TIP. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10691366 ↗
• MalfunctionSep 16, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE WAS BROKEN AT THE SWAGE PART DURING SUTURING ON THE SUBCUTIS. THE NEEDLE BROKE DURING CONTINUOUS SUTURING. THE NEEDLE FRAGMENT WAS FOUND VISUALLY WITHOUT ADDITIONAL INCISIONS, X-RAY EXAMINATIONS, AND EXTENDED OPERATION TIME. THE DOCTOR OPINED THE GRIPPING POSITION WAS BAD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9072302 ↗