Surgipro ll VP-710-XRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521038370), received between Apr 27, 2018 and Sep 16, 2026 — classified as 1 death, 7 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Break

  It was reported that, due to a right sphenoid ridge meningioma, the patient was scheduled to undergo microscopic right craniotomy for cerebral lesion resection under general anesthesia. During dural closure, the suture needle broke while the final stitch was being placed and the needle was being withdrawn. The procedure was immediately stopped, the surgical field was carefully examined, and all needle fragments were completely removed, with no foreign body remaining. The event delayed the patient's operative time. There was no patient injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785223 ↗
• MalfunctionApr 6, 2026Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, PRIOR TO PATIENT USE, THE NEEDLE BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791300 ↗
• MalfunctionJun 14, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A VASCULAR ANASTOMOSIS, THAT ONE THREAD BREAKS. THE REMAINING SUTURE WAS USED WITH NO ISSUE. NOTHING HAPPENS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19539095 ↗
• MalfunctionJan 5, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN ADHESION SEPARATION AFTER LEFT HAND SYNDACTYLY, WHILE ON SKIN SUTURING, IT WAS FOUND THAT THE SUTURE WAS BROKEN FOR UNKNOWN REASONS. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS PROLONGED BUT NOT FOR MORE THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16103106 ↗
• DeathJul 11, 2022Break; Break

  ACCORDING TO THE REPORTER, TWO DAYS FOLLOWING AN ARTERIAL SWITCH OPERATION (SENNING PROCEDURE), THE PATIENT WAS IN THE PROCESS OF WEANING OFF THE VENTILATOR. THE PATIENT APPEARED TO BLEED PROFUSELY THROUGH THE DRAINAGE AND THE INFILTRATION BLOOD PRESSURE DROPPED ALMOST TO 0-10 MMHG. THE SUTURE USED FOR THE ANASTOMOSIS HAD BROKEN IN THE MIDDLE. THE SURGEON TRIED TO CLOSE THE SUTURE WITH ANOTHER THREAD. HOWEVER, AFTER FLUID RESUSCITATION, VASOPRESSOR AND INTENSIVE CARDIOPULMONARY RESUSCITATION WERE INEFFECTIVE AFTER 40 MINUTES. THE PATIENT DIED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14976032 ↗
• MalfunctionJun 1, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHILE CLOSING CARDIAC TISSUE IN A CARDIOVASCULAR SURGERY, THE NEEDLE DEVICE PHYSICALLY BROKE AND A PIECE OF THE NEEDLE FELL INTO THE PATIENT'S CAVITY. SURGEON USED SUCTION AND IRRIGATION DEVICE TO RETRIEVE THE COMPONENT. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11913127 ↗
• MalfunctionJul 9, 2018Break

  ACCORDING TO THE REPORTER, DURING HEART VALVE REPLACEMENT, THE SUTURES BROKE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7669704 ↗
• MalfunctionApr 27, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, WHILE SUTURING DURING CIRCUMCISION, THE NEEDLE BROKE AND THEY RECOVERED ALL THE PARTS. AS STATED, THEY USED ANOTHER SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7468913 ↗