Surgipro ll VP-630-XRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521038042), received between Jun 6, 2017 and Dec 22, 2025 — classified as 1 death, 3 injuries, 4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Break; Break

  IT WAS REPORTED THAT PRE-OPERATIVELY, 1 BOX OF SUTURES WERE BROKEN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23862976 ↗
• DeathJul 11, 2022Break; Break

  ACCORDING TO THE REPORTER, FOLLOWING A PROCEDURE TO TRANSFER PULMONARY VEIN TO LEFT ATRIUM BY PRIMARY SUTURE METHOD AND PATCHING OF ATRIAL SEPTAL DEFECT, THE PATIENT WAS HEMODYNAMICALLY STABLE WITH OPEN STERNUM. ONE HOUR FOLLOWING THE SURGERY, THE PATIENT HAD BLED PROFUSELY THROUGH THE DRAINAGE AND BLOOD PRESSURED DROPPED TO APPROXIMATELY 10MMHG. THE PATIENT WAS GIVEN FLUID AND ACUTE BLOOD TRANSFUSION, INTENSIVE CARDIOPULMONARY RESUSCITATION AND THE PATIENT WAS REOPENED AT THE CHEST. THE PRIMARY SUTURE LINE WAS SEEN TO HAVE BROKEN IN THE MIDDLE. THE SURGEON TRIED TO SUTURE THE ATRIAL SUTURE WITH SIZE 7.0 OTHER POLYPROPYLENE SUTURE, BUT COULD NOT SUTURE. THE PATIENT DIED FROM ACUTE BLOOD LOSS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14976463 ↗
• MalfunctionJul 14, 2021Break; Break

  ACCORDING TO THE REPORTER, ON A BYPASS CORONARY SURGERY, DURING ANASTOMOSIS, 45 MINUTES INTO THE PROCEDURE, USING THE SINGLE SUTURE TECHNIQUE, THE THREAD OF 4 TO 5 SUTURES BROKE. THE SURGICAL TIME WAS EXTENDED FOR 35 MINUTES AND CAUSED DELAY FOR SUBSEQUENT SURGERIES. ANOTHER DEVICE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12170594 ↗
• MalfunctionMar 30, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A KIDNEY TRANSPLANT PROCEDURE, WHEN THE NEEDLE WAS HELD BY A NEEDLE HOLDER, THE SUTURE AND NEEDLE DIVERGED. ANOTHER SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9897825 ↗
• MalfunctionMar 21, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A VASCULAR ANASTOMOSIS, WHEN THE NEEDLE PULL-OUT FROM THE PACKAGE, THE NEEDLE SPONTANEOUSLY DISCONNECTED FROM THE STRAND AND THE THREAD BROKE WITHOUT ANY ABNORMAL FORCE. REPEATED USE OF THE NEW STRAND AND ISSUE HAPPENED AGAIN. A NEW SUTURE USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7358970 ↗
• InjuryJun 6, 2017Break; Break

  ACCORDING TO THE REPORTER: DURING BYPASS ( ANASTOMOSIS) OPEN PROCEDURE, THE THREAD GOT BROKE. THE SUTURE WAS NOT HYDRATED PRIOR TO USE. NO COMPONENT FELL INTO THE PATIENT CAVITY. AN X-RAY WAS PERFORMED. THE SURGICAL TIME WAS EXTENDED DUE TO THE PRODUCT PROBLEM, THE PRODUCT WAS REPLACED WITH THE NEW ONE (SAME MODEL, DIFFERENT LOT NUMBER) IN ORDER TO COMPLETE THE CASE, NO INJURY. PATIENT STATUS: ALIVE - NO INJURY.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient; Radiation Exposure, Unintended

  MAUDE report 6615533 ↗
• InjuryJun 6, 2017Break; Break

  ACCORDING TO THE REPORTER: DURING BYPASS ( ANASTOMOSIS) OPEN PROCEDURE, THE THREAD GOT BROKE. NO COMPONENT FELL INTO THE PATIENT CAVITY. AN X-RAY WAS PERFORMED. THE SURGICAL TIME WAS EXTENDED DUE TO THE PRODUCT PROBLEM, THE PRODUCT WAS REPLACED WITH THE NEW ONE (SAME MODEL, DIFFERENT LOT NUMBER) IN ORDER TO COMPLETE THE CASE, NO INJURY. PATIENT STATUS: ALIVE - NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6614104 ↗
• InjuryJun 6, 2017Break; Break

  ACCORDING TO THE REPORTER: DURING BYPASS ( ANASTOMOSIS) OPEN PROCEDURE, THE THREAD GOT BROKE. THE SUTURE WAS NOT HYDRATED PRIOR TO USE. AN X-RAY WAS PERFORMED. NO COMPONENT FELL INTO THE PATIENT CAVITY. THE SURGICAL TIME WAS EXTENDED DUE TO THE PRODUCT PROBLEM, THE PRODUCT WAS REPLACED WITH THE NEW ONE (SAME MODEL, DIFFERENT LOT NUMBER) IN ORDER TO COMPLETE THE CASE, NO INJURY. PATIENT STATUS: ALIVE - NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6614069 ↗