Surgipro II VP-72-XRecalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 10884521038769), received between Aug 13, 2018 and Mar 23, 2026 — classified as 2 injuries, 66 malfunctions.

The most frequently reported specific device problem is “Break” (58 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 68 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CARDIOVASCULAR PROCEDURE, TWO SUTURES EXPERIENCED NEEDLE-THREAD DETACHMENT WHILE SUTURING OR PREPARING THE SUTURE AFTER PATIENT INCISION. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. THE SUTURES WERE REPLACED WITH NEW ONES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24665194 ↗
• MalfunctionMar 23, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CARDIOVASCULAR PROCEDURE, TWO SUTURES EXPERIENCED NEEDLE-THREAD DETACHMENT WHILE SUTURING OR PREPARING THE SUTURE AFTER PATIENT INCISION. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. THE SUTURES WERE REPLACED WITH NEW ONES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24665102 ↗
• MalfunctionJan 28, 2026Break

  ACCORDING TO THE REPORTER, DURING A DERMATOLOGICAL FACIAL SUTURING, THE SUTURE NEEDLE WAS FOUND TO BE BROKEN WHEN CLAMPED WITH A NEEDLE HOLDER. A NEW SUTURE WAS USED IMMEDIATELY TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 24205631 ↗
• MalfunctionJan 26, 2026Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE USING A 7-0 NON-ABSORBABLE MONOFILAMENT POLYPROPYLENE SUTURE FOR SUTURING, THE SURGEON ENCOUNTERED A NEEDLE BREAKAGE. THE SURGEON IMMEDIATELY STOPPED SUTURING, COLLECTED AND ASSEMBLED THE BROKEN NEEDLE TO CONFIRM ITS COMPLETENESS, AND DID NOT USE IT FURTHER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24184393 ↗
• MalfunctionDec 16, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A MOLE REMOVAL SURGERY, THE SURGEON ENCOUNTERED NEEDLE BREAKAGE. THE SURGEON IMMEDIATELY SEARCHED FOR THE BROKEN NEEDLE, REASSEMBLED IT, AND DID NOT USE IT FURTHER. THE SURGEON THEN REPLACED IT WITH A BRAND NEW, UNOPENED PRODUCT OF THE SAME LOT AND SPECIFICATION, AND NO FURTHER ISSUES WERE FOUND. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23822196 ↗
• MalfunctionNov 18, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT HAD A SKIN MASS ON THE UPPER LIP AND UNDERWENT UPPER LIP MASS EXCISION IN OUR HOSPITAL ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT'S INCISION BECAME RED, SWOLLEN, AND ITCHY, WITH NO EXUDATE OR PUS, AND A REJECTION REACTION WAS SUSPECTED. TO PREVENT FURTHER AGGRAVATION OF THE INCISION AND THE FORMATION OF A PERMANENT SCAR, LOCAL WOUND CARE WAS IMMEDIATELY PROVIDED, THE WOUND WAS RINSED WITH NORMAL SALINE, AND RECOMBINANT COLLAGEN SCAR GEL WAS APPLIED EXTERNALLY. SUBSEQUENT OBSERVATION SHOWED THAT THE SYMPTOMS DISAPPEARED AND THE WOUND GRADUALLY HEALED SMOOTHLY.

  Patient problems: Local Reaction

  MAUDE report 23585881 ↗
• MalfunctionNov 12, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING SURGERY, WHILE USING THE SUTURE TO CLOSE THE PATIENT'S SKIN, THE NEEDLE BROKE INTO TWO PIECES. THE SUTURE WAS REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23532405 ↗
• MalfunctionNov 5, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE BROKE DURING USE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 23476323 ↗
• MalfunctionOct 15, 2025Break; Break

  ACCORDING TO THE REPORTER DURING THE SURGERY, THE SUTURE NEEDLE BROKE. THE BROKEN NEEDLE TIP WAS IMMEDIATELY LOCATED AND A NEW SUTURE WITH NEEDLE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23289014 ↗
• MalfunctionSep 9, 2025Break; Break

  ACCORDING TO THE REPORTER ON (B)(6) 2025, DURING THE SUTURING OF THE POSTOPERATIVE WOUND, THE NEEDLE BROKE. AFTER EXAMINATION BY THE DOCTOR, NO BROKEN NEEDLE FRAGMENTS WERE FOUND TO BE RETAINED IN THE WOUND. THE SUTURE WAS REPLACED AND THE WOUND WAS SUCCESSFULLY SUTURED. THE EVENT DID NOT CAUSE HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23001994 ↗
• MalfunctionOct 8, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING DEBRIDEMENT AND SUTURING ON THE PATIENT, AFTER THE NEEDLE HOLDER WAS USED TO HOLD THE NEEDLE, THE NEEDLE TIP BROKE WHEN THE SUTURE WAS PULLED OUT, WHICH INTERRUPTED THE SURGICAL PROCESS. AFTER THAT, THE SUTURE WAS IMMEDIATELY REPLACED WITH A NEW ONE, AND THE OPERATION WAS CONTINUED. THERE WAS NO PATIENT INJURY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20398566 ↗
• MalfunctionSep 16, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING ENDOBLEPHAROPLASTY WITH TEAR TROUGH REFILLING, AFTER THE NEEDLE HOLDER WAS USED TO HOLD THE NEEDLE DURING THE SUTURING STAGE, THE NEEDLE TIP BROKE WHEN THE SUTURE WAS PULLED OUT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20230966 ↗
• MalfunctionAug 22, 2024Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, TWO SUTURES BROKE. THE SUTURES SNAPPED IN THE MIDDLE. A THIRD PACK OF SUTURE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20033863 ↗
• MalfunctionAug 22, 2024Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, TWO SUTURES BROKE. THE SUTURES SNAPPED IN THE MIDDLE. A THIRD PACK OF SUTURE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20031496 ↗
• MalfunctionJul 2, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN INTERNAL FISTULA PROCEDURE, WHEN THE SURGEON OPENED THE SUTURES AND PREPARED TO LIGATE AND SUTURE BLOOD VESSELS, THE SUTURE WAS CLAMPED WITH FORCEPS AND THE SUTURE WAS BROKEN. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19660725 ↗
• MalfunctionJun 11, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN ARTERIOVENOUS FISTULA RECONSTRUCTION OF THE RIGHT UPPER LIMB, A 7-0 VASCULAR SUTURE WAS USED TO SUTURE THE BLOOD VESSEL. THE SUTURE BROKE WHEN TYING THE FIRST KNOT. THE PATIENT'S BLOOD VESSEL CONDITION WAS POOR (NOT DEVICE RELATED), A NEW 7-0 VASCULAR SUTURE WAS USED TO SUTURE THE BLOOD VESSEL.

  Patient problems: Insufficient Information

  MAUDE report 19513323 ↗
• MalfunctionMar 14, 2024Break; Break

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE SUTURE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18909066 ↗
• MalfunctionMar 6, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN HEART CARDIOVASCULAR (CVS) PROCEDURE, WHILE ATTEMPTING TO HOLD THE NEEDLE WITH A NEEDLE HOLDER RIGHT BEFORE USING, THE NEEDLE SNAPPED. THE BROKEN PIECE DID NOT FALL INTO THE PATIENT'S CAVITY. A NEW DEVICE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18851956 ↗
• MalfunctionJan 9, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE THREE SUTURES BROKE, THERE WAS TENSION WHEN PULLING THE SUTURE OUT, IT BROKE PRIOR TO BEING HANDED TO THE SURGEON, AND IT ALSO BROKE DURING KNOT TYING. OPEN A NEW SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18472897 ↗
• MalfunctionDec 12, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN CORONARY ARTERY BYPASS GRAFTING (CABG) PROCEDURE, AT THE TIME OF DOING DISTAL ANASTOMOSIS, THE TWO THREADS BROKE AFTER AN HOUR VIA THE CONTINUOUS SUTURE TECHNIQUE. ANOTHER BATCH WAS TAKEN TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18313891 ↗
• MalfunctionOct 26, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LIVER TRANSPLANT, WHEN PERFORMING A VASCULAR SUTURE, ALL 3 OF THE THREAD BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18017335 ↗
• MalfunctionOct 26, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LIVER TRANSPLANT, WHEN PERFORMING A VASCULAR SUTURE, ALL 3 OF THE THREAD BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18017327 ↗
• MalfunctionOct 26, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LIVER TRANSPLANT, WHEN PERFORMING A VASCULAR SUTURE, ALL 3 OF THE THREAD BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18017324 ↗
• MalfunctionOct 24, 2023Break; Break

  ACCORDING TO THE REPORTER, ONE HOUR INTO AN OPEN CORONARY ARTERY BYPASS GRAFT (CABG), WHILE EMPLOYING THE CONTINUOUS SUTURING TECHNIQUE FOR DISTAL ANASTOMOSIS, THE THREAD OF THE SUTURE BROKE. ANOTHER SUTURE FROM ANOTHER BATCH WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17997507 ↗
• MalfunctionOct 23, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN CORONARY ARTERY BYPASS GRAFTING (CABG) PROCEDURE, AT THE TIME OF DOING DISTAL ANASTOMOSIS, THE TWO THREADS BROKE AFTER AN HOUR VIA THE CONTINUOUS SUTURE TECHNIQUE. ANOTHER BATCH WAS TAKEN TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17990237 ↗