Surgipro ll VPF-706-XRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521039933), received between Oct 20, 2017 and Nov 25, 2024 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN EMERGENCY PROCEDURE, WHEN THE PACKAGING WAS OPENED, PRIOR TO PATIENT USE, IT WAS FOUND THAT THE NEEDLE WAS BROKEN. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20771692 ↗
• MalfunctionJul 13, 2021Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHEN SUTURING THE NERVE, THE NEEDLE SUDDENLY BROKE. SURGICAL TIME WAS EXTENDED FOR ABOUT FIVE MINUTES AS A RESULT OF THE EVENT. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 12164391 ↗
• MalfunctionJan 18, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN REDUCTION AND INTERNAL FIXATION FOR ZYGOMATIC FRACTURE, THE SUTURE NEEDLE WAS USED TO CLOSE THE ABDOMEN, THE SUTURE NEEDLE WAS BROKEN, WHICH MADE IT UNUSABLE AND INCREASED THE RISK OF SURGERY. IMMEDIATELY SEARCH FOR THE BROKEN NEEDLE AND FIND THE BROKEN END STUMP. THE TWO BROKEN ENDS WERE ANASTOMOSED, THE INCISION WAS CLEANED, AND AFTER CONFIRMING THAT THERE WAS NO FOREIGN MATTER REMAINING, REPLACE THE SUTURE NEEDLE TO CONTINUE SUTURING. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11186780 ↗
• MalfunctionDec 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDED DISENGAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9410642 ↗
• MalfunctionJul 2, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A VASCULAR SURGERY, DURING ANASTOMOSIS, THE 2 REPORTED NEEDLE DEVICE BROKE. SURGEON USED ANOTHER SUTURE FROM THE SAME LOT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8755519 ↗
• MalfunctionNov 29, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING CARDIOVASCULAR BYPASS SURGERY, BOTH THE NEEDLE AND THREAD BROKE AND THEY COULD NOT FIND THE NEEDLE WHEN THEY WERE ABOUT TO TIE THE BLOOD VESSEL. THE SURGICAL TIME WAS EXTENDED BECAUSE IT TOOK THEM AN HOUR TO FIND THE NEEDLE BEFORE CONTINUING THE SURGERY. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7066854 ↗
• InjuryOct 20, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, WHEN THE KNOT WAS ABOUT TO BE DONE WHILE SUTURING THE BLOOD VESSELS DURING AN OPEN HEART VALVE REPLACEMENT SURGICAL PROCEDURE, THE NEEDLE SUDDENLY DISAPPEARED. THEY HAD TO SEARCH THE NEEDLE FOR MORE THAN AN HOUR UNTIL FIND IT, WHICH LEAD TO A DELAY IN SURGERY. ANESTHESIA TIME WAS DELAYED FOR MORE THAN 1 HOUR AS THE RESULT OF THE SUSPENSION OF THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6966102 ↗