Surgipro II VP-556XRecalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 10884521037892), received between Aug 1, 2017 and May 15, 2026 — classified as 1 death, 17 injuries, 71 malfunctions.

The most frequently reported specific device problem is “Break” (83 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 89 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Break

  ACCORDING TO THE REPORTER, THERE WAS A FREQUENT BREAK OF THREAD DURING USE.

  Patient problems: Insufficient Information

  MAUDE report 25194120 ↗
• MalfunctionOct 21, 2025Break; Break

  ACCORDING TO THE REPORTER DURING A PROCEDURE FOR LACERATION ON THE SKIN OF THE RIGHT FOREARM, THE SURGEON PERFORMED DEBRIDEMENT AND SUTURING; AFTER THE FIRST NEEDLE WAS INSERTED INTO THE SKIN, THE SUTURE NEEDLE BROKE AND ENTERED THE TISSUE. THE BROKEN NEEDLE WAS IMMEDIATELY REMOVED. ANOTHER SUTURE OF THE SAME MODEL WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23345615 ↗
• MalfunctionOct 20, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN ALARPLASTY FOR NASAL ALAR HYPERTROPHY, WHILE SUTURING THE INCISION, THE NEEDLE TIP BROKE AND WAS REMOVED. EXPLORATION OF THE INCISION REVEALED NO RESIDUAL NEEDLE TIP OR FOREIGN BODIES. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 23337623 ↗
• DeathSep 4, 2025Break; Break

  IT WAS REPORTED THAT DURING A LIVER TRANSPLANTATION, THE NEEDLE BODY OF THE SUTURE BROKE WHILE SUTURING THE INFERIOR VENA CAVA, AND THE BROKEN NEEDLE FELL INTO THE PATIENT'S BODY CAVITY. NO ATTEMPT OR X-RAY WAS MADE TO LOCATE OR RETRIEVE THE NEEDLE; HOWEVER, EMERGENCY MEASURES WERE TAKEN. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THE SUTURE WAS REPLACED WITH A PRODUCT FROM ANOTHER MANUFACTURER TO COMPLETE THE PROCEDURE. IT WAS SUBSEQUENTLY REPORTED DURING FOLLOW-UP THAT THE PATIENT DIED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22965367 ↗
• MalfunctionAug 22, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING SUTURING, THE NEEDLE BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22880109 ↗
• MalfunctionJul 17, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PULMONARY ARTERY PROCEDURE, WHEN SUTURING AND REPAIRING THE RUPTURED LUNG, THE SUTURE WAS VERY EASY TO BREAK. THE SURGEON WAS REPLACED WITH SUTURE OF OTHER BRAND TO COMPLETE THE SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22529479 ↗
• MalfunctionMay 8, 2025Break; Break

  ACCORDING TO THE REPORTER, IN A TRAUMA DEBRIDEMENT AND SUTURING PROCEDURE, WHILE PERFORMING INTERRUPTED SKIN SUTURES, THE NEEDLE BROKE. THE ISSUE HAPPENED WITH TWO SUTURES. NO DEVICE COMPONENT FELL INTO THE PATIENT¿S CAVITY. THE SUTURE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986881 ↗
• MalfunctionMay 8, 2025Break; Break

  ACCORDING TO THE REPORTER, IN A TRAUMA DEBRIDEMENT AND SUTURING PROCEDURE, WHILE PERFORMING INTERRUPTED SKIN SUTURES, THE NEEDLE BROKE. THE ISSUE HAPPENED WITH TWO SUTURES. NO DEVICE COMPONENT FELL INTO THE PATIENT¿S CAVITY. THE SUTURE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986863 ↗
• MalfunctionMar 11, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  DUPLICATE OF PE (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 21575548 ↗
• MalfunctionMar 11, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  DUPLICATE OF (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 21575543 ↗
• MalfunctionMar 11, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, DURING A PARTIAL ASCENDING AORTA RESECTION WITH AN ARTIFICIAL BLOOD VESSEL REPLACEMENT PROCEDURE, THE NEEDLE BROKE AND FELL INTO THE PATIENT¿S BODY. THIS ISSUE OCCURRED ON THREE DEVICES. THE USER WAS ABLE TO REMOVE THE NEEDLES IN TIME. THE SAME SUTURE FROM THE SAME PACKAGE WAS THEN USED.

  Patient problems: Insufficient Information

  MAUDE report 21575539 ↗
• MalfunctionMar 7, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN THORACIC PARTIAL RESECTION OF THE ASCENDING AORTA WITH ARTIFICIAL VASCULAR REPLACEMENT PROCEDURE, THE NEEDLE BROKE THREE TIMES CONSECUTIVELY. THIS RESULTED IN THE LOSS OF THE NEEDLE IN THE PATIENT'S BODY. NO X-RAY WAS PERFORMED AND AFTER SEARCHING, ALL THE NEEDLES WERE FOUND. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 21554326 ↗
• MalfunctionMar 7, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN THORACIC PARTIAL RESECTION OF THE ASCENDING AORTA WITH ARTIFICIAL VASCULAR REPLACEMENT PROCEDURE, THE NEEDLE BROKE THREE TIMES CONSECUTIVELY. THIS RESULTED IN THE LOSS OF THE NEEDLE IN THE PATIENT'S BODY. NO X-RAY WAS PERFORMED AND AFTER SEARCHING, ALL THE NEEDLES WERE FOUND. IT WAS NOTED THE SURGICAL PROCEDURE WAS EXTENDED FOR LESS THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 21554225 ↗
• MalfunctionMar 7, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN THORACIC PARTIAL RESECTION OF THE ASCENDING AORTA WITH ARTIFICIAL VASCULAR REPLACEMENT PROCEDURE, THE NEEDLE BROKE THREE TIMES CONSECUTIVELY. THIS RESULTED IN THE LOSS OF THE NEEDLE IN THE PATIENT'S BODY. NO X-RAY WAS PERFORMED AND AFTER SEARCHING, ALL THE NEEDLES WERE FOUND. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 21552802 ↗
• MalfunctionOct 11, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN UPPER LIMB ARTERIOVENOUS FISTULA BALLOON DILATATION, ANGIOGRAPHY REVEALED A THROMBUS, SO THE THROMBUS WAS REMOVED BY INCISION. THE DEVICE WAS THEN USED, BUT THE NEEDLE BROKE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. IT WAS NOTED THAT THE PROCEDURE WAS EXTENDED FOR LESS THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20431770 ↗
• MalfunctionJul 17, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC RADICAL RESECTION OF THE RIGHT LUNG CANCER, THE SURGEON USED A VASCULAR SUTURE, AFTER SUTURING TWO STITCHES, THE NEEDLE IN THE CHEST CAVITY WAS TAKEN OUT AND THE NEXT SUTURE WAS ABOUT TO BE PERFORMED, BUT IT WAS FOUND THAT THE SUTURE NEEDLE WAS ACCIDENTALLY BROKE INTO TWO PIECES. THE HEAD NURSE WAS NOTIFIED AND IMMEDIATELY SEARCHED FOR THE NEEDLE IN THE SURGICAL AREA AND ON THE OPERATING TABLE. THEN, THE BROKEN NEEDLE WAS FOUND IN THE CLEAN BAG ON THE OPERATING TABLE. THE HAND-WASHING NURSE AND THE CIRCULATING NURSE CHECKED THE INTEGRITY OF THE NEEDLE TOGETHER. AFTER CONFIRMING THAT IT WAS INTACT, THE HEAD NURSE AND THE SURGEON WAS INFORMED AND THREW THE NEEDLE INTO THE SHARPS BOX. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19760896 ↗
• InjuryJun 21, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN MAJOR VASCULAR SURGERY, OFF-PUMP BYPASS, AND VASCULAR SUTURING PROCEDURE, FOUR NEEDLES BROKE. AN X-RAY WAS PERFORMED TO LOCATE THE NEEDLE, BUT IT COULD NOT BE FOUND. THE SURGICAL TIME WAS EXTENDED TO FIND THE BROKEN NEEDLES, DELAYING CHEST CLOSURE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THE BROKE NEEDLE WAS NOT FOUND AND IT WAS IMPOSSIBLE TO CONFIRM WHETHER THE BROKEN NEEDLE WAS OUTSIDE THE BODY OR INSIDE THE BODY.

  Patient problems: Foreign Body In Patient; Tissue Breakdown; Unintended Radiation Exposure

  MAUDE report 19581293 ↗
• InjuryJun 21, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN MAJOR VASCULAR SURGERY, OFF-PUMP BYPASS, AND VASCULAR SUTURING PROCEDURE, FOUR NEEDLES BROKE. AN X-RAY WAS PERFORMED TO LOCATE THE NEEDLE, BUT IT COULD NOT BE FOUND. THE SURGICAL TIME WAS EXTENDED TO FIND THE BROKEN NEEDLES, DELAYING CHEST CLOSURE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THE BROKE NEEDLE WAS NOT FOUND AND IT WAS IMPOSSIBLE TO CONFIRM WHETHER THE BROKEN NEEDLE WAS OUTSIDE THE BODY OR INSIDE THE BODY.

  Patient problems: Foreign Body In Patient; Tissue Breakdown; Unintended Radiation Exposure

  MAUDE report 19580693 ↗
• InjuryJun 20, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN MAJOR VASCULAR SURGERY, OFF-PUMP BYPASS, AND VASCULAR SUTURING PROCEDURE, FOUR NEEDLES BROKE. AN X-RAY WAS PERFORMED TO LOCATE THE NEEDLE, BUT IT COULD NOT BE FOUND. THE SURGICAL TIME WAS EXTENDED TO FIND THE BROKEN NEEDLES, DELAYING CHEST CLOSURE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THE BROKE NEEDLE WAS NOT FOUND AND IT WAS IMPOSSIBLE TO CONFIRM WHETHER THE BROKEN NEEDLE WAS OUTSIDE THE BODY OR INSIDE THE BODY.

  Patient problems: Foreign Body In Patient; Tissue Breakdown; Unintended Radiation Exposure

  MAUDE report 19578125 ↗
• InjuryJun 20, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN MAJOR VASCULAR SURGERY, OFF-PUMP BYPASS, AND VASCULAR SUTURING PROCEDURE, FOUR NEEDLES BROKE. AN X-RAY WAS PERFORMED TO LOCATE THE NEEDLE, BUT IT COULD NOT BE FOUND. THE SURGICAL TIME WAS EXTENDED TO FIND THE BROKEN NEEDLES, DELAYING CHEST CLOSURE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THE BROKE NEEDLE WAS NOT FOUND AND IT WAS IMPOSSIBLE TO CONFIRM WHETHER THE BROKEN NEEDLE WAS OUTSIDE THE BODY OR INSIDE THE BODY.

  Patient problems: Foreign Body In Patient; Tissue Breakdown; Unintended Radiation Exposure

  MAUDE report 19578123 ↗
• MalfunctionJun 3, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, ON THE LEFT INDEX FINGER, AFTER DEBRIDEMENT, THE NEEDLE HANDLE WAS BROKEN DURING SUTURING. TO RESOLVE THE ISSUE, ANOTHER NON-ABSORBABLE SUTURE WAS USED. IT WAS NOTED THAT THE SUTURING TIME WAS PROLONGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19445140 ↗
• MalfunctionMay 24, 2024Break; Break

  ACCORDING TO THE REPORTER, IN AN OPEN TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVI), DURING POUCH CREATION USING THE CONTINUOUS SUTURING TECHNIQUE, THE NEEDLE BROKE.

  Patient problems: Insufficient Information

  MAUDE report 19397952 ↗
• InjuryMar 26, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PANCREATODUODENECTOMY PROCEDURE, THE NEEDLE TIP OF THE 5-0 VASCULAR SLIDING THREAD WAS BROKEN DUE TO EXCESSIVE FORCE WHEN CLAMPING OR SUTURING. THE SURGEON REFUSED TO SEARCH, SAYING THAT THERE WAS NO WAY TO FIND IT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18978787 ↗
• MalfunctionMar 13, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING HEMANGIOMA RESECTION, THE SURGEON USED ABSORBABLE SUTURE THROUGH ENDOSCOPIC INSTRUMENTS WHILE SUTURING THE RIGHT HEPATIC VEIN BLEEDING POINT, THE NEEDLE BROKE AND THE FRONT END OF THE NEEDLE FELL INTO THE LIVER TISSUE. TO RESOLVE THE ISSUE, THE SURGEON SWUNG THE BROKEN COMPONENT AWAY FROM THE ABDOMEN.

  Patient problems: Insufficient Information

  MAUDE report 18899933 ↗
• MalfunctionJan 8, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE NEEDLE BROKE WHEN THE SECOND STITCH WAS SUTURED. TO RESOLVE THE ISSUE, THE SUTURE NEEDLE WAS REPLACED TO PERFORM SECONDARY SUTURING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18472075 ↗