Surgipro ll VPF-711-XRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521039988), received between Jan 6, 2020 and Sep 21, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

• InjurySep 21, 2026Detachment of Device or Device Component

  According to the reporter, the patient underwent an atrial septal defect repair. During suturing, the needle detached from the 5-0 suture. The surgical staff observed that only the suture remained in the needle holder and that the needle was missing. A search was conducted on and around the operating table, as well as within the surgical incision; however, the needle could not be located. Theradiology department was immediately notified, and bedside digital radiography was performed, which revealed that the suture needle was located within the patient's incision. The needle was subsequently removed surgically without delay.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 50841670 ↗
• InjurySep 18, 2026Break

  According to the reporter, during cardiac surgical suturing, the suture needle was found to have a missing tip of approximately 1 mm when it was handed to the scrub nurse. The surgeon was notified immediately, and the surgeon, circulating nurse, and scrub nurse searched for the missing needle tip, but it was not found. Bedside chest X-ray (DR - Digital Radiography) was then performed in radiology, which also did not identify the missing tip. The surgical time extended by more than 30 minutes.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 50820316 ↗
• MalfunctionApr 24, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE NEEDLE AND THREAD BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24976036 ↗
• MalfunctionApr 21, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A PROCEDURE PRIOR PATIENT USE, THE NEEDLE AND THREAD BROKE. A NEW SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24936035 ↗
• MalfunctionJun 24, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING SUTURING OF THE INCISION, THE SUTURE BROKE AND THE WOUND NEEDED TO BE RE-SUTURED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19594293 ↗
• MalfunctionFeb 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN BENTALL PROCEDURE, IN THE EARLY STAGES OF SUTURING, THE THREE NEEDLES AND THREADS BROKE THAT FORCED THE SURGEON TO REDO THE SUTURING STEP FROM THE BEGINNING AND MAKE A DOUBLE LAYER OF SUTURE TO MAKE SURE THE DEVICE WOULD NOT BREAK AGAIN AND HAD TO USE ANOTHER DEVICE FROM A DIFFERENT MANUFACTURER. THE EVENT LED TO EXTENDED SURGICAL TIME OF MORE THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18667516 ↗
• MalfunctionMar 31, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN DEBRIDEMENT AND SUTURE WERE PERFORMED, THERE WERE NODULES NEAR THE NEEDLE OF THE SUTURE THAT AFFECTED THE USE. THE SUTURE WAS CUT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16660031 ↗
• MalfunctionJan 6, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING THE SKIN CLOSURE WHEN SUTURING THE PATIENT'S WOUNDS AFTER THE NEEDLE PASSES THRU THE SKIN THE SUTURE NEEDLE BREAKS. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9553021 ↗