Surgipro ll VPF-702-XRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10884521039889), received between Sep 14, 2017 and Dec 13, 2024 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE SUTURES, THERE WERE MULTIPLE MALFUNCTIONS WHERE THE SUTURE ENTANGLED, BROKE, AND THE NEEDLE DETACHED. IT WAS NOTED THAT MORE THAN ONE DEFECTIVE DEVICE WAS INVOLVED IN THE SAME EVENT WITH THE SAME PATIENT. TO RESOLVE THE ISSUE, FOUR SUTURES WERE REQUIRED. THE EVENT OCCURRED AT A FACILITY IN CALI, COLOMBIA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20929654 ↗
• MalfunctionDec 12, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREE SUTURES FROM THE SAME BATCH HAVE BROKEN THREAD. THE FOURTH SUTURE WAS USED TO RESOLVE THE ISSUE.

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

  MAUDE report 20917701 ↗
• MalfunctionDec 12, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREE SUTURES FROM THE SAME BATCH HAVE BROKEN THREAD. THE FOURTH SUTURE WAS USED TO RESOLVE THE ISSUE.

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

  MAUDE report 20917285 ↗
• MalfunctionDec 12, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREE SUTURES FROM THE SAME BATCH HAVE BROKEN THREAD. THE FOURTH SUTURE WAS USED TO RESOLVE THE ISSUE.

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

  MAUDE report 20916822 ↗
• MalfunctionNov 17, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN CARDIOVASCULAR SURGERY, THE THREAD OF THE SEVEN SUTURES BROKE. THE SUTURES WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18158077 ↗
• MalfunctionNov 17, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN CARDIOVASCULAR SURGERY, THE THREAD OF THE SEVEN SUTURES BROKE. THE SUTURES WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18158073 ↗
• MalfunctionNov 17, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN CARDIOVASCULAR SURGERY, THE THREAD OF THE SEVEN SUTURES BROKE. THE SUTURES WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18158072 ↗
• MalfunctionNov 17, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN CARDIOVASCULAR SURGERY, THE THREAD OF THE SEVEN SUTURES BROKE. THE SUTURES WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18158071 ↗
• MalfunctionNov 17, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN CARDIOVASCULAR SURGERY, THE THREAD OF THE SEVEN SUTURES BROKE. THE SUTURES WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18158070 ↗
• MalfunctionNov 17, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN CARDIOVASCULAR SURGERY, THE THREAD OF THE SEVEN SUTURES BROKE. THE SUTURES WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18158069 ↗
• MalfunctionNov 17, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN CARDIOVASCULAR SURGERY, THE THREAD OF THE SEVEN SUTURES BROKE. THE SUTURES WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18158047 ↗
• MalfunctionSep 26, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN MYOCARDIAL REVASCULARIZATION, IN THE MYOCARDIUM, THREE SUTURES WERE BROKEN. THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15486622 ↗
• MalfunctionNov 18, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CARDIAC SURGERY, BOTH THE NEEDLE AND THREAD BROKE ON TWO SUTURES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 10860305 ↗
• MalfunctionMar 23, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN ANASTOMOSIS OF A VESSEL PROCEDURE USING A NORMAL TECHNIQUE, THE SUTURE THREAD BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9869736 ↗
• MalfunctionDec 17, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A CARDIAC SURGERY OPEN PROCEDURE, THE THREAD BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Information

  MAUDE report 9481107 ↗
• MalfunctionNov 8, 2019Break; Break

  ACCORDING TO THE REPORTER, AT THE END OF THE DISTAL ANASTOMOSIS, THE SURGEON PERFORMED KNOTTED WITH INDICATED HYDRATION AND SAME TENSION FORCE USUALLY APPLIED TO THE SUTURE AND THE THREAD BROKE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN THIRTY MINUTES FOR THE PATIENT TO HAVE MORE EXPOSURE TO THE EXTRACORPOREAL CIRCULATION MACHINE SINCE IT WAS NECESSARY TO REPEAT THE ENTIRE ANASTOMOSIS. THEY CHANGED THE SUTURE TO ANOTHER BRAND TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Failure to Anastomose; No Consequences Or Impact To Patient

  MAUDE report 9298710 ↗
• InjuryNov 7, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, WHEN PERFORMING ANASTOMOSIS OF THE ARTERY, USING A CONTINUOUS SUTURE, THE THREAD BROKE AND FELL INTO THE CAVITY OF THE PATIENT. THEY USED ANOTHER SUTURE MARK TO COMPLETE THE CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8047375 ↗
• InjuryNov 7, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, WHEN PERFORMING AN ARTERY ANASTOMOSIS, USING A CONTINUOUS SUTURE, THE THREAD BROKE AND FELL INTO THE CAVITY OF THE PATIENT. A SUTURE OF DIFFERENT THREAD AND CALIBER WERE USED WHICH CAUSED THE EVENT TO LEAD TO AN EXTENDED HOSPITALIZATION OF THE PATIENT DUE TO THE INCREASE OF OBSERVATION TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 8047359 ↗
• MalfunctionOct 26, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CARDIOVASCULAR ANASTOMOSIS PROCEDURE, THE NEEDLE OF THE DEVICE DETACHED. THEY USED ANOTHER STRAND TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8009227 ↗
• MalfunctionOct 16, 2017Break; Break

  ACCORDING TO THE REPORTER: OCCURRED DURING AN OPEN MYOCARDIAC REVASCULARIZATION PROCEDURE. THE SUTURE WAS TREATED OR HYDRATED PRIOR TO USE WITH SERUM. THE THREAD OF THE SUTURE BROKE THREE HOURS INTO THE PROCEDURE WHILE PERFORMING THE NORMAL SUTURE TECHNIQUE. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, ANOTHER SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT HARM. THE PATIENT OUTCOME IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6951409 ↗
• MalfunctionSep 14, 2017Break; Break

  ACCORDING TO THE REPORTER, ON (B)(6) 2017, INTRA-OPERATIVELY, THE DEVICE HAD A PACKAGING ISSUE, THE PACKAGING HAD PROBLEMS OF DESIGN AS THAT IN SOME OCCASIONS THE THREAD BREAKS WHEN IT WAS BEING REMOVED FROM THE PACKAGING. A NEW DEVICE WAS USED IN ORDER TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6866428 ↗