Surgipro II VP-776-XRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10884521039261), received between Mar 21, 2018 and Feb 20, 2024 — classified as 3 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (22 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE NEEDLE DETACHED FROM THE SUTURE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738290 ↗
• MalfunctionApr 13, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN SURGICAL REPAIR OF THE LEFT FEMORAL ARTERY, WHEN USING SUTURE ON THE PATIENT, THE THREAD BROKE. NO COMPONENT FELL INTO THE PATIENT CAVITY. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY. WHEN THE DEVICE WAS PICKED UP FOR RETURN, THE NEEDLE TIP WAS ALSO FOUND BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16734587 ↗
• MalfunctionMar 28, 2023Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE BROKE WHEN IT PASSED THROUGH THE PROSTHESIS DURING THE ANASTOMOSIS. IT WAS A BROKEN PROSTHESIS.

  Patient problems: Insufficient Information

  MAUDE report 16632828 ↗
• MalfunctionMar 24, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A PROSTHETIC FEMORAL PERONEAL BYPASS, THE NEEDLE BROKE WHILE PASSING THROUGH THE PROSTHESIS DURING THE ANASTOMOSIS. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16615369 ↗
• MalfunctionFeb 22, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE IN THE CAROTID ARTERY, THE NEEDLE 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 16417798 ↗
• MalfunctionFeb 6, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, SUTURING OF PATCH CAROTID, ONE NEEDLE BROKE AND ANOTHER NEEDLE DIVIDED FROM THREAD. A NEW SUTURE FROM A DIFFERENT MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16304180 ↗
• MalfunctionNov 7, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN BYPASS PROCEDURE, WHEN AT THE VESSEL, THE NEEDLE BROKE AND NEEDLE DETACHED FOR TWO SUTURES FROM THE PARTICULAR BOX. THE NEEDLE BROKE AND THEY REMOVED THE BROKEN PARTS OF THE NEEDLES FROM THE PATIENT. THE SURGEON REPLACED IT WITH ANOTHER SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15749067 ↗
• InjuryOct 12, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ILEO-FEMORAL BYPASS, WHEN THE SURGEON TRIED TO TAKE THE THREAD OUT OF ITS HOLDER WITH A NEEDLE HOLDER, THE NEEDLE BROKE. ANOTHER SUTURE OF THE SAME LOT NUMBER WAS OPENED TO PERFORMED THE ANASTOMOSIS AT THE START OF THE OVERLOCK, HOWEVER THE NEEDLE BROKE. REDO OF ANASTOMOSIS WAS PERFORMED IN QUESTION AND ABOVE ALL TO FIND THE TIP OF THE NEEDLE INTO PATIENTS CAVITY, HOWEVER THE MISSING TIP OF THE NEEDLE FOUND. THE SURGEON HAD TO CHANGE WOOL FOR A BIGGER NEEDLE AND A BIGGER THREAD. THIS WAS THE FOURTH SUCH STATEMENT ON THIS REFERENCE. REGARDING THE INCRIMINATED BATCH, THERE HAVE ALREADY BEEN TWO OTHER DECLARATIONS WITH THE SAME LOT NUMBER.

  Patient problems: Failure to Anastomose

  MAUDE report 15588029 ↗
• MalfunctionOct 1, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING ILIO-FEMORAL BYPASS, WHILE ON THE POPLITEAL ARTERY USING THE RUNNING STITCH TECHNIQUE DURING BRIDGING ANASTOMOSIS, THE NEEDLE BROKE WHEN SUTURING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED, HOWEVER, IT WAS UNKNOWN IF IT WAS MORE THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15524473 ↗
• MalfunctionSep 27, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A CAROTID SURGERY, THE SURGEON USED SEVERAL NEEDLE TO SUTURE THE EDGES OF THE ARTERY, THE NEEDLE BREAKS EFFORTLESSLY WITH EACH PASS INTO THE TISSUE. NOT HAVING PUT A CAROTID SHUNT, THE TOTAL CLAMPING WAS MUCH LONGER, MOREOVER THE REPEATED PASSAGE OF THE NEEDLE OVER THE SAME AREA COULD CAUSE TEARING OF THE TISSUES. SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES. PROLONGED WAIT FOR PATIENT TO WAKE-UP TO CHECK FOR ISCHEMIA.

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

  MAUDE report 15495375 ↗
• MalfunctionSep 8, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A VASCULAR SURGERY, WHILE SUTURING A VESSEL THE NEEDLE BROKE. A NEW SUTURE WAS USED TO RESOLVED THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15382470 ↗
• MalfunctionAug 31, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE NEEDLE BROKE.

  Patient problems: Insufficient Information

  MAUDE report 15329465 ↗
• MalfunctionAug 17, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFT, THE FIRST TWO SUTURES WERE RUPTURED FROM THE SWAGE AND THE SECOND TWO SUTURES WERE RUPTURED FROM THE MIDDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15241395 ↗
• MalfunctionJul 22, 2022Material Frayed; Adverse Event Without Identified Device or Use Problem; Material Frayed; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, VENTRICULAR SEPTAL DEFECT CLOSURE, THE NEEDLE BROKE AND FORTUNATELY DID NOT FALL INTO THE BODY. THE DOCTOR CHANGED THE SUTURE BUT THREE SUTURES FRAYED WHILE KNOT TYING. SURGEON AND NURSE CHANGED THE DEVICE TO RESOLVE THE ISSUE. SURGICAL PROCEDURE WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO DEVICE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15085238 ↗
• MalfunctionJul 22, 2022Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, VENTRICULAR SEPTAL DEFECT CLOSURE, THE NEEDLE BROKE AND FORTUNATELY DID NOT FALL INTO THE BODY. THE DOCTOR CHANGED THE SUTURE BUT THREE SUTURES FRAYED WHILE KNOT TYING. SURGEON AND NURSE CHANGED THE DEVICE TO RESOLVE THE ISSUE. SURGICAL PROCEDURE WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO DEVICE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15085173 ↗
• MalfunctionMay 23, 2022Break; Break

  ACCORDING TO THE REPORTER, ON AN OPEN ABDOMINAL CORONARY ARTERY BYPASS SURGERY, DURING THE ANASTOMOSIS OF BLOOD VESSELS, THERE WAS A THREAD BREAKAGE AT THE TIME OF LIGATION AND STITCHING. ANOTHER DEVICE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14473732 ↗
• MalfunctionMay 4, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, ONE BOX OF THE SUTURE WAS OPENED TO UTILIZE SIX NEEDLES. THE MIDDLE GOT BROKE DURING USE. THE SURGEON PULLED OUT A SECOND LOT OFF THEIR SHELVES TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14272866 ↗
• MalfunctionMay 3, 2022Break; Break

  ACCORDING TO THE REPORTER, WHILE USING THE MATERIALS, THE SURGEON HAD SIX NEEDLES BROKE IN HALF. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 14269806 ↗
• MalfunctionMar 8, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A CAROTID PROCEDURE, WHILE STITCHING TO CLOSE THE CAROTID, THE THREAD BROKE. THE SURGEON CONTINUED USING THE SAME SUTURE AND USED ADDITIONAL SUTURE WITH THE SAME LOT NUMBER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13698598 ↗
• InjuryMar 29, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, NEEDLE BROKE. IT FELL INTO THE CAVITY OF THE PATIENT AND AN X-RAY WAS PERFORMED TO LOCATE THE NEEDLE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 11584374 ↗
• MalfunctionJun 5, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN CORONARY ARTERY BYPASS GRAFTING (CABG), SIX THREADS BROKE. AN ADDITIONAL PRODUCT WAS USED TO COMPLETE THE CASE.

  Patient problems: No Information

  MAUDE report 8671789 ↗
• InjuryMay 14, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING AN ENDARTERECTOMY, WHILE THEY WERE CREATING AN ANASTOMOSIS USING A RUNNING TECHNIQUE IN SUTURING, THE SUTURE BROKE EASILY. RUNNING DOWN THE KNOT WAS DIFFICULT, THE DEVICE WAS USED TWICE DURING THE PROCEDURE. THE ANASTOMOSIS MADE WITH THE SUTURE ON THE BACK OF ARTERY BROKE. THE PATIENT LOSS MORE THAN 500 CC OF BLOOD AND GOT 2, 5L OF EXTERNAL BLOOD. THE TIME OF THE PROCEDURE WAS EXTENDED MORE THAN 30 MINUTES. ANOTHER ANASTOMOSIS WAS DONE, RUNNING TECHNIQUE WAS PERFORMED TO REPAIR, WITH THE SAME TYPE OF SUTURE WITH THE SAME PRODUCT ID AND LOT NO. A SINGLE STITCH TECHNIQUE INTERRUPTED WAS USED WITHOUT ISSUE

  Patient problems: Blood Loss; No Code Available

  MAUDE report 7511965 ↗
• MalfunctionMar 30, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE PERFORMING VASCULAR ANASTOMOSIS, BOTH NEEDLE AND THREAD WERE BROKEN. NO REPORTED PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7385346 ↗
• MalfunctionMar 21, 2018Break; Break

  ACCORDING TO THE REPORTER DURING LIGATION, THE THREAD BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7357315 ↗