Surgipro ll VP-710-MXRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521038363), received between Jul 1, 2021 and Mar 28, 2022 — classified as 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (12 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.

• InjuryMar 28, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN HEART PROCEDURE, WHILE BEING APPLIED TO A VESSEL, THE NEEDLE BROKE IN TWO PIECES AND FELL INTO THE PATIENT¿S CAVITY AND WAS RETRIEVED BY A NEEDLE GRASPER. AN X-RAY WAS PERFORMED TO FIND THE COMPONENT OR CONFIRM THAT ALL PIECES WERE LOCATED.

  Patient problems: Unintended Radiation Exposure; Unspecified Tissue Injury

  MAUDE report 13929002 ↗
• InjuryFeb 4, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE NEEDLE BROKE AND PART OF IT WAS MISSING AND FELL INTO THE PATIENT'S CAVITY. AN X-RAY WAS USED IN PURPOSE TO LOCATE THE COMPONENT. THE SURGICAL TIME WAS EXTENDED FOR 30 MINUTES OR MORE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 13459784 ↗
• MalfunctionDec 7, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING TETHERED CORD REPAIR, THE NEEDLE BROKE. THE SURGEON CONTINUED TO OBTAIN ADDITIONAL SUTURES TO CONTINUE THE CASE. THE SURGICAL TIME WAS EXTENDED BY 45 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12957084 ↗
• InjuryDec 7, 2021Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, NEEDLE FROM MULTIPLE SUTURES BROKE WHILE IN USE OR NEAR SURGICAL FIELD. ALL PIECES WERE RECOVERED AND WERE NOT LEFT IN PATIENT. AN X-RAY WAS PERFORMED TO MAKE SURE NO FRAGMENTS WERE LEFT.

  Patient problems: Insufficient Information; Unintended Radiation Exposure

  MAUDE report 12955314 ↗
• InjuryDec 7, 2021Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, NEEDLE FROM MULTIPLE SUTURES BROKE WHILE IN USE OR NEAR SURGICAL FIELD. ALL PIECES WERE RECOVERED AND WERE NOT LEFT IN PATIENT. AN X-RAY WAS PERFORMED TO MAKE SURE NO FRAGMENTS WERE LEFT.

  Patient problems: Insufficient Information; Unintended Radiation Exposure

  MAUDE report 12955050 ↗
• MalfunctionOct 28, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN CARDIOTHORACIC SURGERY, THE SURGEON WAS TREATING THE NEEDLE AS A POP OFF AND THE NEEDLE BROKE AS A RESULT OF PULLING IT OFF OF THE SUTURE STRAND WITH THE NEEDLE DRIVER INSTEAD OF CUTTING IT OFF  THE USER RETRIEVED THE BROKEN PIECES AND CONTINUE WITH A NEW SUTURE STRAND. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712878 ↗
• InjuryOct 28, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING OPEN CARDIOTHORACIC SURGERY, THE SURGEON WAS TREATING THE NEEDLE AS A POP OFF AND THE NEEDLE BROKE AS A RESULT OF PULLING IT OFF OF THE SUTURE STRAND WITH NEEDLE DRIVER INSTEAD OF CUTTING IT OFF. THE SURGEON THOUGHT THEY RETRIEVED ALL PIECES OF NEEDLE AND CONTINUE WITH NEW STRAND, HOWEVER A TINY PART OF THE NEEDLE WAS FOUND ON A SUBSEQUENT UNRELATED X-RAY 5 DAYS LATER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12712815 ↗
• InjuryJul 12, 2021Break; Break

  ACCORDING TO THE REPORTER DURING ATRIAL SEPTAL DEFECT REPAIR PROCEDURE, THE SURGEON WAS REMOVING THE NEEDLE FROM THE SUTURE WHEN THE NEEDLE BROKE. SINCE THE BROKEN PART COULD NOT BE FOUND, AN X-RAY WAS DONE AT THE END OF THE CASE. THE PATIENT'S X-RAY WAS CLEAR.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 12151067 ↗
• InjuryJul 6, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN EMPLOYING A INTERMITTED SUTURING IN A VESSEL ON AN OPEN HEART PROCEDURE, TWO NEEDLES BROKE AND DISENGAGED INTO PATIENT CAVITY. TO RETRIEVED THE NEEDLE, AN X-RAY WAS PERFORMED. THE SURGEON OPENED NEW NEEDLES WITH A DIFFERENT LOT NUMBER TO COMPLETE THE CASE.

  Patient problems: Unintended Radiation Exposure; Unspecified Tissue Injury

  MAUDE report 12123821 ↗
• InjuryJul 6, 2021Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING AN OPEN HEART PROCEDURE, THE NEEDLE OF THE DEVICE BROKE. AN X-RAY WAS USED TO LOCATE THE PIECE AND IT WAS CONFIRMED THAT NOTHING WAS LEFT INSIDE THE PATIENT'S CAVITY. A NEW SUTURE WAS USED TO COMPLETE THE CASE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 12123340 ↗
• MalfunctionJul 1, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING AN OPEN HEART TRANSPLANT, THE NEEDLE BROKE AND FELL OFF INTO THE PATIENT'S CAVITY. IT WAS THEN RETRIEVED USING FORCEPS AND A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12099461 ↗
• MalfunctionJul 1, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER ON AN OPEN HEART TRANSPLANT DURING VALVE REPLACEMENT, THE NEEDLE BROKE AND FELL OFF INTO THE PATIENT'S CAVITY. THE BROKEN PIECE WAS RETRIEVED USING FORCEPS AND A NEW SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12099431 ↗