Surgipro ll VP-709-XRecalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10884521038301), received between Oct 24, 2017 and Dec 19, 2022 — classified as 10 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Break” (50 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 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE NEEDLE BROKE THREE TIMES IN A ROW IN ONE BOX. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16011285 ↗
• MalfunctionJul 11, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A VASULAR PROCEDURE, WHILE CLOSING AN ARTERY, THE NEEDLE DETACHED FROM THE THREAD AND THE NEEDLE BROKE ON ONE SUTURE AND THE OTHER SUTURE'S THREAD BROKE. A PART OF THE SUTURE NEEDLE FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED WITHOUT INTERVENTION. AN ALTERNATIVE PRODUCT WAS USE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14979737 ↗
• MalfunctionMar 29, 2022Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE NEEDLE BROKE WHILE SUTURING THE ARTIFICIAL VESSEL AND THE AUTO-VESSEL ANASTOMOSIS. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE.

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

  MAUDE report 13942675 ↗
• MalfunctionMar 18, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN VESSEL POPLITEAL ANASTOMOSIS, WHILE THE DEVICE WAS IN THE VESSEL, USING A VENOUS VESSEL ANASTOMOSIS SUTURING TECHNIQUE, 12 NEEDLES BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13815984 ↗
• MalfunctionFeb 22, 2022Break; Break

  ACCORDING TO THE REPORTER, THE NEEDLE WAS BROKEN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13578348 ↗
• MalfunctionFeb 22, 2022Break; Break

  ACCORDING TO THE REPORTER, THE NEEDLE WAS BROKEN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13578278 ↗
• InjuryJan 7, 2022Break; Unraveled Material; Break; Unraveled Material

  ACCORDING TO THE REPORTER, DURING AN OPEN-HEART SURGERY-ANASTOMOSIS PROCEDURE, WHILE SUTURING THE GRAFT, AND BEING ANASTOMOSED, THE THREAD BROKE. RESUTURING WAS NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THERE WAS A BLOOD LOSS OF 500CC OR MORE DUE TO THE PRODUCT PROBLEM AND BLOOD TRANSFUSION WAS REQUIRED. THE INCISION WAS EXTENDED. THE SUTURE WAS CHANGED TO COMPLETE THE CASE AND RESOLVE THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13196834 ↗
• InjuryJan 5, 2022Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE NEEDLE BECAME LOOSE AND BROKE. X-RAY WAS PERFORMED TO MAKE SURE ALL PIECES WERE LOCATED. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 13169892 ↗
• MalfunctionNov 19, 2021Break; Break

  ACCORDING TO THE REPORTER, ON AN OPEN ABDOMINAL EXTRACARDIAC PROCEDURE, WHILE SUTURING, THE NEEDLE BREAKAGE OF 2 SUTURES OCCURRED CONSECUTIVELY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12845031 ↗
• InjuryNov 18, 2021Break; Product Quality Problem; Dull, Blunt; Detachment of Device or Device Component; Human-Device Interface Problem; Break; Product Quality Problem; Dull, Blunt; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE NEEDLE DEFORMED AND SEPARATED FROM THE THREAD. THE SHAPE OF THE NEEDLE ROTATED IN THE NEEDLE HOLDER. THE NEEDLE ALSO QUICKLY BECAME BLUNT ESPECIALLY IN CALCIFIED VESSELS. THE SUTURE BROKE DURING SUTURING AND TYING KNOTS. THE THREAD DID NOT PULL THROUGH THE TISSUES AS SMOOTHLY. THERE WAS ALSO A NEEDLE HOLE BLEEDING WHEN USING SYNTHETIC GRAFTS WHICH PROLONGED THE OPERATING TIME WAITING FOR HAEMOSTASIS. THERE WAS A MISMATCH BETWEEN THE SUTURE AND THE NEEDLE¿S DIAMETER WHICH LEFT A LARGER HOLE THAN THE THREAD AND BLEEDING THROUGH THE HOLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 12833991 ↗
• MalfunctionNov 1, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHILE BEING APPLIED TO STITCH THE VESSEL DURING AN OPEN ANASTOMOSIS AT CAROTID VESSEL, THE NEEDLE BROKE, AND NEEDLE TIP FELL INTO THE PATIENT¿S CAVITY AND WAS RETRIEVED USING ATRAUMATIC VASCULAR FORCEPS. ANOTHER SUTURE WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12728135 ↗
• MalfunctionOct 25, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN VESSEL POPLITEAL ANASTOMOSIS, WHILE THE DEVICE WAS IN THE VESSEL, USING A VENOUS VESSEL ANASTOMOSIS SUTURING TECHNIQUE, 12 NEEDLES BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12688771 ↗
• InjurySep 23, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING GENERAL SURGERY, THE INCIDENT HAPPENED TWICE WHEN THE NEEDLE OF THE THREAD BROKE INTO THE WALL OF THE PATIENT'S ARTERY. AN X-RAY WAS DONE AND THE NEEDLE WAS RETRIEVED BEFORE ENTERING THE CIRCULATION.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 12519023 ↗
• InjurySep 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING GENERAL SURGERY, HAPPENED TWICE WHEN THE NEEDLE OF THE THREAD BROKE INTO THE WALL OF THE PATIENT'S ARTERY. AN X-RAY WAS DONE AND THE NEEDLE WAS RETRIEVED BEFORE ENTERING THE CIRCULATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 12447314 ↗
• InjuryAug 16, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING ANASTOMOSIS TO THE ARTIFICIAL BLOOD VESSEL, THE NEEDLE OF 2 SUTURES BROKE. AN X-RAY WAS PERFORMED TO CONFIRM ALL PIECES WERE LOCATED. A COMPETITOR DEVICE WAS USED TO CONTINUE THE CASE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 12329443 ↗
• MalfunctionAug 10, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING ANASTOMOSIS WITH AN ARTIFICIAL BLOOD VESSEL, THE NEEDLE BROKE FROM THE 3 SUTURES. ALSO WHILE DOING SUBCUTANEOUS SUTURING USING 2 SUTURES FROM ANOTHER PRODUCT MODEL, THE THREADS BROKE. RE-ANASTOMOSIS WAS PERFORMED USING A COMPETITOR PRODUCT.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 12301722 ↗
• MalfunctionJun 2, 2021Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, TWO NEEDLES BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 11925892 ↗
• MalfunctionJun 2, 2021Break; Break

  ACCORDING TO THE REPORTER, ALL THE THREE SUTURE NEEDLES SNAPPED IN HALF DURING A PROCEDURE. ANOTHER SUTURE WAS OPENED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 11925826 ↗
• MalfunctionJun 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO THE PROCEDURE, NEEDLE AND STRAND DETACHED UPON OPENING THE PACKAGE. THE OPERATOR USED ANOTHER SUTURE TO RESOLVE THE ISSUE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11912876 ↗
• MalfunctionMay 17, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE NEEDLE BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11835641 ↗
• MalfunctionMay 5, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING LEFT LOWER EXTREMITY ARTERIOGRAM WITH CO2, STENT AGNIOPLASTY LEFT SUPERIOR FEMORAL ARTERY, BALLOON ANGIOPLASTY LEFT TP CHUNK AND POSTERIOR TIBIAL ARTERY, PART OF NEEDLE WAS BROKEN WHILE STITCHING OF ANASTOMOSIS IN LEFT LEG. ALL PIECES WERE GATHERED. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11781060 ↗
• InjuryApr 29, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN CAROTID PROCEDURE, A TOTAL OF THREE NEEDLES WERE BROKEN IN THE TRANSMURAL SUTURE. IT WAS STATED THAT THE NEEDLES BROKE OFF IN THE FRONT HALF AND FELL INTO THE PATIENT. THE BROKEN NEEDLES WERE FOUND AND REMOVED FROM THE PATIENT. NEW SUTURES WERE USED. AFTER THE OPERATION, THE PATIENT WAS X-RAYED FOR SAFETY. THE SURGICAL TIME WAS EXTENDED TO 30 MINUTES OR MORE SINCE THE PATIENT HAD TO BE X-RAYED.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 11747179 ↗
• MalfunctionApr 27, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING FEM-POP PROCEDURE, UPON SUTURING GRAFT INTO VESSEL, THE NEEDLE BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11731830 ↗
• MalfunctionApr 13, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING ANASTOMOSES OF THE VESSELS, THE NEEDLE PART OF THE SUTURE BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11660915 ↗
• MalfunctionMar 31, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN THROMBOENDARTERECTOMY, THE NEEDLE BROKE AND FELL INTO THE PATIENT'S CAVITY. IT WAS RETRIEVED BY USING A NEEDLE HOLDER. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11597279 ↗