Surgipro ll VP-726-XRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521038684), received between Jun 14, 2018 and Aug 26, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT DURING CARDIOVASCULAR SURGERY TO A PATIENT WITH AORTIC VALVE INSUFFICIENCY AND THORACIC AORTIC ANEURYSM, THE SUTURE SHOWED LITTLE RESISTANCE TO MAINTAINING TENSION AND BROKE IN THE MIDDLE WHILE SUTURING, RESULTING IN EXTENDED SURGICAL TIME. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893932 ↗
• MalfunctionAug 5, 2025Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A CARDIOVASCULAR PROCEDURE, THE SUTURE BROKE IN THE MIDDLE WHILE SUTURING. THE SUTURE OFFERED LITTLE RESISTANCE TO MAINTAINING TENSION. THE SURGICAL TIME WAS EXTENDED AS A RESULT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22718763 ↗
• MalfunctionOct 18, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE WIRE BROKE AT THE OPENING WHEN NO TENSION HAD BEEN APPLIED.. A NEW SUTURE FROM THE SAME BATCH WAS USED WITHOUT ANY ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15626283 ↗
• MalfunctionJun 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE DISPATCHED FROM THE SUTURE. ANOTHER BATCH OF PRODUCTS WAS TAKEN TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12033466 ↗
• MalfunctionDec 30, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING FEMORAL ENDARTERECTOMY PROCEDURE, THE SUTURE BROKE ONCE THE SURGEON TRIED TO MAKE A KNOT. IN ADDITION, THE SURGEON FOUND OUT THAT THERE WAS BLEEDING IN SOME POINT. TO RESOLVE THE ISSUE, THE SURGEON APPLY AN EXTRA SUTURE TO STOP BLEEDING AND USED ANOTHER DEVICE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11097068 ↗
• MalfunctionJan 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE NEEDLE WAS DETACHED FROM THE THREAD AND FELL INTO THE CAVITY OF THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9610267 ↗
• MalfunctionNov 5, 2019Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material

  ACCORDING TO THE REPORTER, DURING AN OPEN CARDIOVASCULAR PROCEDURE, THE SUTURE COULD NOT BE REMOVED FROM THE PACKAGE EASILY. SUTURE STRAND GOT CAUGHT ON THE SIDE OF THE PACKAGING. THE NEEDLE HOLDER WAS ATTACHED TO THE NEEDLE AND PULLED THE NEEDLE OFF TRYING TO GET THE SUTURE OUT OF THE PACKAGE. THE NEEDLE CAME OFF WHILE ATTEMPTING TO REMOVE. STAFF OPENED ANOTHER SUTURE PACK AND USED A NEW SUTURE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9282966 ↗
• InjuryAug 14, 2019Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT HAD TO BE RE-OPERATED FOR ISCHEMIA OF THE LOWER LEFT LIMB A DAY AFTER A FEMORAL TRIPOD AND LEFT FEMOROPOPLITEAL BYPASS DUE TO HEMORRHAGE. IT WAS STATED THAT THE THREAD USED FOR THE ANASTOMOSIS OF THE VESSELS BROKE. IT WAS STATED THAT THREE DEVICES HAD THE SAME MALFUNCTION DURING THE SAME EVENT. ANOTHER SURGERY WAS DONE TO RESOLVE THE ISSUE. THE EVENT RESULTED THE PATIENT¿S EXTENDED HOSPITAL STAY. THE PATIENT INCURRED A TEMPORARY INJURY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Injury; No Code Available

  MAUDE report 8894066 ↗
• MalfunctionMar 8, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING EXPLORATION OF RIGHT WRIST (NERVE/TENDON REPAIR), DURING THE TENDON REPAIR WHILE PERFORMING CONTINUOUS SUTURING, THE PART OF THE NEEDLE BROKE AND FELL INTO PATIENT'S CAVITY. THE BROKEN-OFF PORTION OF THE NEEDLE WAS IMMEDIATELY RETRIEVED BY THE SURGEON. THEY USED ANOTHER SUTURE TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8403552 ↗
• MalfunctionAug 8, 2018Break

  ACCORDING TO THE REPORTER, DURING CORONARY ARTERY BYPASS SURGERY, WHILE SEWING THE FEMORAL ARTERY, THE THREAD BROKE ON TWO DEVICES. THEY OPENED A NEW SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7762092 ↗
• MalfunctionJun 14, 2018Detachment Of Device Component; Detachment of Device or Device Component; Detachment Of Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: DURING AN OPEN PROCEDURE FOR POLYTETRAFLUOROETHYLENE (PTFE) PROSTHESIS CONSTRUCTION AND VEIN ANASTOMOSIS, THE NEEDLE DETACHED FROM THE SUTURE. THE NEEDLE FELL INTO THE PATIENT'S CAVITY. PRIOR TO USE THE SUTURE WAS TREATED/HYDRATED WITH SALINE. REPLACED BY A NEW DEVICE TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7601632 ↗
• MalfunctionJun 14, 2018Detachment Of Device Component; Detachment of Device or Device Component; Detachment Of Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: DURING AN OPEN PROCEDURE FOR POLYTETRAFLUOROETHYLENE (PTFE) PROSTHESIS CONSTRUCTION AND VEIN ANASTOMOSIS, THE NEEDLE DETACHED FROM THE SUTURE. THE NEEDLE FELL INTO THE PATIENT'S CAVITY. PRIOR TO USE THE SUTURE WAS TREATED/HYDRATED WITH SALINE. REPLACED BY A NEW DEVICE TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7601520 ↗