Surgipro II VP-74-XRecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10884521038974), received between May 2, 2017 and Sep 15, 2026 — classified as 13 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Break” (31 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 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Break

  According to the reporter, during the liver transplant, while suturing the vena cava, the needle broke and the needle tip entered the blood vessel. The needle tip was promptly searched for and found. The suture needle was replaced with another to complete the procedure. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774755 ↗
• MalfunctionAug 6, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50154155 ↗
• MalfunctionDec 25, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING THE SURGERY, AFTER USING THE VASCULAR SUTURE, IT BROKE AT A POINT ABOUT ONE-QUARTER FROM THE TAIL END. THREE-QUARTERS OF THE SUTURE NEEDLE IN THE ABDOMINAL CAVITY WAS EJECTED, LEAVING ONLY THE REMAINING QUARTER. THE SURGERY WAS IMMEDIATELY STOPPED TO SEARCH THE ABDOMINAL AND PELVIC CAVITIES. FINALLY, RADIOGRAPHIC IMAGING WAS PERFORMED, BUT NOTHING WAS FOUND IN THE BODY.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 23892605 ↗
• InjuryNov 26, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PANCREATIC TUMOR RESECTION AT THE BLOOD VESSEL STEP, THE NEEDLE BROKE AND A COMPONENT (NEEDLE) FELL INTO THE CAVITY OF THE PATIENT AND WAS NOT FOUND, RESULTING IN A RETAINED NEEDLE FRAGMENT. AN X-RAY WAS PERFORMED TO LOCATE THE MISSING NEEDLE/COMPONENT. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES. THE SURGERY WAS COMPLETED.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 23656068 ↗
• MalfunctionApr 22, 2025Break; Break

  ACCORDING TO THE REPORTER DURING THE SURGERY, THE NEEDLE BROKE TWICE WHILE SUTURING THE NERVE. THE FIRST BROKEN NEEDLE WAS REMOVED AND REPLACED WITH ANOTHER, BUT THE SECOND NEEDLE BROKE SHORTLY AFTER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21886777 ↗
• MalfunctionApr 22, 2025Break; Break

  ACCORDING TO THE REPORTER DURING THE SURGERY, NEEDLE BROKE TWICE WHILE SUTURING THE NERVE. THE FIRST BROKEN NEEDLE WAS REMOVED AND REPLACED WITH ANOTHER, BUT THE SECOND NEEDLE BROKE SHORTLY AFTER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885077 ↗
• InjuryJan 18, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN BREAST REDUCTION SURGERY, WHILE SUTURING THE SKIN, A TOTAL OF SIX NEEDLES WERE BROKEN. AN X-RAY WAS PERFORMED AND THE SURGICAL EXTENSION TOOK TWO HOURS TO FIND THE NEEDLE. A NEW NEEDLE FROM ANOTHER MANUFACTURER WAS USED FOR SUTURING AND COMPLETING THE CASE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 18537595 ↗
• InjuryJan 18, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN BREAST REDUCTION SURGERY, WHILE SUTURING THE SKIN, A TOTAL OF SIX NEEDLES WERE BROKEN. AN X-RAY WAS PERFORMED AND THE SURGICAL EXTENSION TOOK TWO HOURS TO FIND THE NEEDLE. A NEW NEEDLE FROM ANOTHER MANUFACTURER WAS USED FOR SUTURING AND COMPLETING THE CASE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 18537421 ↗
• InjuryJan 18, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN BREAST REDUCTION SURGERY, WHILE SUTURING THE SKIN, A TOTAL OF SIX NEEDLES WERE BROKEN. AN X-RAY WAS PERFORMED AND THE SURGICAL EXTENSION TOOK TWO HOURS TO FIND THE NEEDLE. A NEW NEEDLE FROM ANOTHER MANUFACTURER WAS USED FOR SUTURING AND COMPLETING THE CASE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 18537298 ↗
• InjuryJan 18, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN BREAST REDUCTION SURGERY, WHILE SUTURING THE SKIN, A TOTAL OF SIX NEEDLES WERE BROKEN. AN X-RAY WAS PERFORMED AND THE SURGICAL EXTENSION TOOK TWO HOURS TO FIND THE NEEDLE. A NEW NEEDLE FROM ANOTHER MANUFACTURER WAS USED FOR SUTURING AND COMPLETING THE CASE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 18537138 ↗
• InjuryJan 17, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN BREAST REDUCTION SURGERY, WHILE SUTURING THE SKIN, A TOTAL OF SIX NEEDLES WERE BROKEN. AN X-RAY WAS PERFORMED AND THE SURGICAL EXTENSION TOOK TWO HOURS TO FIND THE NEEDLE. A NEW NEEDLE FROM ANOTHER MANUFACTURER WAS USED FOR SUTURING AND COMPLETE THE CASE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 18531245 ↗
• InjuryJan 17, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN BREAST REDUCTION SURGERY, WHILE SUTURING THE SKIN, A TOTAL OF SIX NEEDLES WERE BROKEN. AN X-RAY WAS PERFORMED AND THE SURGICAL EXTENSION TOOK TWO HOURS TO FIND THE NEEDLE. A NEW NEEDLE FROM ANOTHER MANUFACTURER WAS USED FOR SUTURING AND COMPLETE THE CASE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 18530947 ↗
• MalfunctionOct 12, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE WAS BROKEN. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 17926125 ↗
• MalfunctionNov 17, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, ONE OF THE SUTURES NEEDLE BROKE AND ONE SUTURE BROKE. A COMPETITOR DEVICE WAS USED TO RESOLVE THE ISSUE. RE-SUTURING OF THE ATRIAL INCISION WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15818012 ↗
• InjuryNov 11, 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 CARDIAC BYPASS SURGERY, IN SUTURING THE BLOOD VESSEL, THREE SUTURES BROKE. THE SURGEON USED THE DEVICE TO SUTURE THE LEFT INTERNAL MAMMARY ARTERY (LIMA) TO THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE SUTURE BODY WAS BROKEN DURING THE BYPASS PROCESS, AND THE VASCULAR ANASTOMOSIS SUTURE COULD NOT BE COMPLETED. THIS CAUSED THE ANASTOMOTIC STOMA TO BE UNABLE TO CLOSE NORMALLY. THE SUTURES THAT HAVE BEEN SEWN ARE DISCONNECTED FROM EACH OTHER. THE SURGEON NEEDED TO PULL OUT THE BROKEN END OF THE SUTURE. DURING THIS OPERATION, THE ANASTOMOSIS WAS DAMAGED MISTAKENLY AND IT WAS NECESSARY TO TRIM THE OPEN END OF THE LEFT INTERNAL MAMMARY ARTERY VESSEL AND REPAIR THE SIDE OF THE LEFT ANTERIOR DESCENDING ARTERY. THE SURGICAL TIME WAS EXTENDED FOR 15 MINUTES TO DISASSEMBLE AND REPAIR THE DEVICE, AND THE FINAL SUTURE WAS MORE THAN 30 MINUTES LONGER THAN USUAL. AFTER THAT, THE SUTURE FROM OTHER MANUFACTURER WAS REPLACED TO COMPLETE THE SUTURE. IT WAS NOTED THAT THERE WILL BE ADDITIONAL OPERATION PERFORMED TO CORRECT THE ISSUE. THE PATIENT IS CURRENTLY WITHOUT LIFE-THREATENING.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15784606 ↗
• MalfunctionMay 6, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PARTIAL LIVER RESECTION, DURING VASCULAR SUTURED, THE NEEDLE BROKE. THE SURGEON USED ANOTHER DEVICE TO RE-SUTURE AND COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14307389 ↗
• MalfunctionApr 19, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LIVER TRANSPLANT, WHILE AT VASCULAR ANASTOMOSIS, THE NEEDLE WAS BROKEN. A NEW SUTURE WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14141817 ↗
• MalfunctionApr 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, NEEDLE AND THREAD BROKE ON THREE SUTURES.

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

  MAUDE report 14069187 ↗
• InjuryApr 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CARDIAC PROCEDURE, ALL 3 REPORTED SUTURE DEVICE'S NEEDLE WERE RIPPING OFF THE SUTURE TOO EARLY AND SOMETIMES IT WAS HARD TO FIND THE NEEDLES. PATIENT HAD UNDERGONE X-RAY TO ENSURE NEEDLE WAS NOT INSIDE. THE NEEDLE WAS NOT FOUND BUT WAS NOT IN THE PATIENT EITHER. SURGEON OPENED ANOTHER BOX TO RESOLVE THE ISSUE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 14069183 ↗
• InjuryApr 5, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A KIDNEY TRANSPLANT, WHILE AT VASCULAR ANASTOMOSIS, THE NEEDLE BROKE. THE BLOOD VESSELS NEEDED TO BE RE-ANASTOMOSED IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 14014027 ↗
• InjuryMar 23, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN LIVER CANCER SURGERY, WHILE SUTURING IN THE BLEEDING LOCATION, THE NEEDLE WAS BROKEN IN THE BODY, AND THE PATIENT MIGHT NOT BE ABLE TO HAVE AN MRI CHECK. AN X-RAY WAS PERFORMED FOR THE EXPRESS PURPOSE OF LOCATING THE COMPONENT, OR CONFIRMING THAT ALL PIECES WERE LOCATED, AND THE NEEDLE WAS FOUND IN THE LIVER. THE SURGICAL TIME WAS EXTENDED 1-2 HOURS DUE TO THE PRODUCT PROBLEM.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 13862967 ↗
• MalfunctionAug 31, 2021Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING CARDIAC MAJOR VASCULAR SURGERY, WHEN SUTURING THE RADIAL ARTERY, THE NEEDLE OF 2 SUTURES BROKE. A PRODUCT FROM ANOTHER BRAND WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12399701 ↗
• InjuryJun 19, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A COMPLETE ECTOPIC DRAINAGE (INTRACARDIAC) CORRECTION AND MITRAL VALVULOPLASTY, THE SUTURE WAS BRO KEN TWICE IN THE POSTERIOR 1/3 AND THE ANTERIOR 2/3 OF THE NEEDLE BODY ALSO BROKE. THE SURGEON FOUND OUT THAT THE BROKEN NEEDLE BODY WAS ON THE HEART PATCH. SO, X-RAY WAS PERFORMED, AND THE NEEDLE TIP WAS RETRIEVED. THIS RESULTED TO EXTENDED SURGICAL TIME FOR ABOUT 10 MINUTES.

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 10172846 ↗
• MalfunctionJan 28, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING VASCULAR ANASTOMOSIS ON A LIVER TRANSPLANT PROCEDURE, THE SUTURE NEEDLE WAS RUPTURED. THE BROKEN NEEDLE WAS CHECKED FOR COMPLETENESS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9637575 ↗
• MalfunctionJan 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A VASCULAR ANASTOMOSIS ON LIVER TRANSPLANTATION, THE THREAD WAS RUPTURED FROM THE NEEDLE. THE OPERATION WAS COMPLETED BY REPLACING THE SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9616456 ↗