Surgipro ll VP-706-XRecalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 10884521038264), received between Aug 10, 2017 and Feb 2, 2026 — classified as 1 death, 15 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Break” (41 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 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Break

  ACCORDING TO THE REPORTER, DURING A TISSUE CLOSURE, THE NEEDLE BROKE. THE SURGERY WAS PAUSED IN ORDER TO LOCATE THE BROKEN NEEDLE. THE TIP OF THE BROKEN NEEDLE WAS FOUND. THE SURGICAL TIME WAS EXTENDED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

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

  MAUDE report 24242652 ↗
• MalfunctionJan 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE CONNECTION OF THE NEEDLE AND THREAD BROKE. THE ISSUE OCCURRED IN FIVE SUTURES.

  Patient problems: Insufficient Information

  MAUDE report 21085353 ↗
• MalfunctionJan 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE CONNECTION OF THE NEEDLE AND THREAD BROKE. THE ISSUE OCCURRED IN FIVE SUTURES.

  Patient problems: Insufficient Information

  MAUDE report 21085245 ↗
• MalfunctionJan 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE CONNECTION OF THE NEEDLE AND THREAD BROKE. THE ISSUE OCCURRED IN FIVE SUTURES.

  Patient problems: Insufficient Information

  MAUDE report 21085228 ↗
• MalfunctionJan 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE CONNECTION OF THE NEEDLE AND THREAD BROKE. THE ISSUE OCCURRED IN FIVE SUTURES.

  Patient problems: Insufficient Information

  MAUDE report 21085201 ↗
• MalfunctionDec 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE CONNECTION OF THE NEEDLE AND THREAD BROKE. THE ISSUE OCCURRED IN FIVE SUTURES.

  Patient problems: Insufficient Information

  MAUDE report 20880816 ↗
• MalfunctionNov 19, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, DURING A WOUND CLOSURE PROCEDURE, THE WOUND WAS CLEANED AND SUTURED WITH NON-ABSORBABLE SINGLE-STRAND SUTURE. THREE DAYS LATER, THE SKIN AROUND THE SUTURE WAS FOUND TO BE RED AND SWOLLEN. AFTER REMOVAL AND LOCAL DISINFECTION, THE ABOVE SYMPTOMS GRADUALLY IMPROVED UNTIL HEALING.

  Patient problems: Inflammation

  MAUDE report 20724705 ↗
• MalfunctionNov 15, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING THE SKIN CLOSURE AFTER THE PATIENT UNDERWENT MANDIBULAR BONE REMOVAL AND INTERNAL FIXATION. WHILE SUTURING, THE SUTURE NEEDLE BROKE, WHICH GREATLY INCREASED THE PATIENT'S OPERATION TIME. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS INCREASED BY LESS THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20694500 ↗
• MalfunctionJun 13, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN CARDIOVASCULAR HEART SURGERY, DURING VASCULAR ANASTOMOSIS, THE TWO DEVICES BROKE. THE TWO SUTURES WERE USED AS IS. A NEW SUTURE WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19528728 ↗
• MalfunctionJun 13, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN CARDIOVASCULAR SURGERY, DURING VASCULAR ANASTOMOSIS, THE TWO SUTURES BROKE. THE TWO SUTURES WERE USED AS IS. A NEW SUTURE WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19528479 ↗
• MalfunctionMar 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A VASCULAR SURGERY OPEN PROCEDURE , WHEN MOUNTING THE STRAND ON THE NEEDLE HOLDER, THE NEEDLE DETACHED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18977964 ↗
• 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 18667459 ↗
• MalfunctionAug 16, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE PATIENT WAS DEBRIDED AND SUTURED WITH NON-ABSORBABLE SINGLE-STRAND SUTURE DUE TO CONTUSION AND LACERATION OF THE UPPER LIP. ABOUT FIVE DAYS, THE SKIN AROUND THE SUTURE WAS RED AND SWOLLEN, AND THE WOUND HEALING WAS NOT GOOD. REMOVED THE SUTURE AND USED OTHER SUTURES FOR SUTURING. SUBSEQUENTLY, THE WOUND HEALED WELL, AND THE ABOVE SYMPTOMS NO LONGER APPEARED.

  Patient problems: Erythema; Impaired Healing; Inflammation

  MAUDE report 17558409 ↗
• InjuryAug 16, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, ONE WEEK POST-OPERATIVE OF A DEBRIDEMENT AND SUTURE WITH NON-ABSORBABLE SINGLE-STRAND POLYPROPYLENE SUTURE OF A PEDIATRIC PATIENT DUE TO A PENETRATING INJURY OF THE RIGHT MOUTH, WHICH WAS A 1CM WOUND FALL ON THE UPPER LIP, THE SKIN AT THE SUTURE SITE WAS RED AND SWOLLEN. THE WOUND HEALED POORLY. THE SUTURE IRRITATED THE LOCAL WOUND. THE SUTURE WAS REMOVED. THE LOCAL SKIN WAS DISINFECTED AND SUTURED AGAIN WITH OTHER SUTURE. THE PATIENT WAS ANESTHETIZED BEFORE RE-SUTURING. THE WOUND GRADUALLY HEALED AND IMPROVED.

  Patient problems: Erythema; Impaired Healing; Inflammation; Unspecified Tissue Injury

  MAUDE report 17558194 ↗
• MalfunctionJul 13, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CAROTID BYPASS SURGERY, THE SUTURE NEEDLE HAD BROKE IN TWO. THE DEVICE PIECES DISENGAGED INTO THE PATIENT CAVITY. BOTH ENDS WERE FOUND AND KEPT. ANOTHER DEVICE WAS USED TO COMPLETE THE ANASTOMOSIS.

  Patient problems: Insufficient Information

  MAUDE report 17317675 ↗
• MalfunctionJun 23, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A HAND JOINT FRACTURE PROCEDURE, WHEN THE SURGEON WAS SUTURING THE SOFT TISSUE, THE NEEDLE SUDDENLY BROKE. FORTUNATELY, THE BROKEN NEEDLE DID NOT ENTER THE DEEP TISSUE. THE SURGEON QUICKLY PICKED UP THE BROKEN END, COMPARED THE BROKEN END, AND FIXED THE BROKEN NEEDLE ON THE NEEDLE BOARD. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17194902 ↗
• InjuryJun 28, 2022Break; Break

  ACCORDING TO THE REPORTER, POST OPERATIVELY, ON A MINIMALLY INVASIVE SURGERY THROUGH THE RIGHT THORACIC LINE, PATCHING THE VENTRICULAR SEPTAL DEFECT WITH A MESH, AFTER SUDDEN BLEEDING OF MORE THAN 500CC, THE PATIENT'S BLOOD PRESSURE WAS 10-20 MMHG, CARDIAC ARREST, WAS TREATED WITH CARDIOPULMONARY RESUSCITATION, FLUID RESUSCITATION AND VASOPRESSOR WITH A DIAGNOSIS OF FULMINANT BLOOD LOSS. THE SURGICAL TEAM COOPERATED WITH RESUSCITATION, AND ANESTHESIA AND MIDLINE THORACOTOMY. THE USER FOUND OUT THE BREAK IN THE MIDDLE OF THE FIVE ATRIAL SUTURES INCLUDING TWO LAYERS AND THE TWO ENDS OF THE THREAD WERE STILL INTACT. THE OPERATOR CONDUCTED A PAIR OF ATRIAL CLAMPS, SUTURED THE ATRIAL SUTURE WITH SQUEEZING THE THREAD WITH TWO LAYERS. IT WAS NOTED THAT COMPENSATION FOR BLOOD, FLUID, COORDINATED WITH ACTIVE RESUSCITATION, THE PATIENT HAD A RHYTHM AGAIN, OCCURRED VENTRICULAR FIBRILLATION, ELECTRIC SHOCK OF 10 JOULES, SINUS RHYTHM. RESUSCITATION WAS EFFECTIVE, HEMODYNAMIC STABILITY AND THE SURGEON CLOSED THE CHEST MIDLINE FOR THE PATIENT. THE PATIENT WAS HOSPITALIZED.

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

  MAUDE report 14845737 ↗
• MalfunctionMay 23, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A HEAVY EYELID SURGERY, WHILE SUTURING THE SKIN BY CONTINUOUS SUTURE, THE NEEDLE OF ONE OF THE SUTURES BROKE AND THE THREAD OF THE OTHER TWO SUTURES 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 14474121 ↗
• DeathFeb 1, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN-HEART SURGERY-ANASTOMOSIS, WHILE SUTURING THE GRAFT, AND BEING ANASTOMOSED, THE 2 THREADS BROKE. RE SUTURING WAS NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THERE WAS A BLOOD LOSS AT THE SUTURING SITE OF 500CCOR MORE DUE TO THE PRODUCT PROBLEM AND BLOOD TRANSFUSION WAS REQUIRED. THE INCISION WAS EXTENDED. THE SUTURE WAS CHANGED TO RESOLVE THE ISSUE. IT WAS NOTED THE PATIENT DIED.

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

  MAUDE report 13419428 ↗
• 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 13196969 ↗
• 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 13196752 ↗
• 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 13196673 ↗
• 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 12833986 ↗
• MalfunctionJul 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHEN SUTURING, THE NEEDLE CAME LOOSE FROM THE THREAD OF 6 SUTURES. A REPLACEMENT WAS PROVIDED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12218709 ↗
• MalfunctionJul 12, 2021Break; Break

  ACCORDING TO THE REPORTER, WHEN IN VESSEL ANASTOMOSIS ON AN OPEN PROCEDURE, THE THREAD OF SEVERAL DEVICES BROKE. THE DEFECT WAS SEEN ON TWO DIFFERENT MODEL NUMBER. TO RESOLVE THE ISSUE, THE SURGEON USED A DEVICE WITH A DIFFERENT SIZE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12151222 ↗