Surgipro ll VP-702-XRecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10884521038141), received between Aug 31, 2017 and Oct 20, 2025 — classified as 5 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Break” (29 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SKIN MASS REMOVAL FROM THE LEFT CHEEK, WHILE CLOSING THE SKIN, THE DEVICE BROKE AT THE JUNCTION OF THE NEEDLE AND THREAD. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337550 ↗
• MalfunctionJan 8, 2025Break; Break

  IT WAS REPORTED THAT THE VP-702-X SURGIPRO*II 7-0 BLU 60CM CV1 DA SUTURE EXPERIENCED A BREAKAGE ISSUE. THE STRAND WAS NOTED TO BREAK EASILY. AN EXCHANGE OF DEVICE WAS DONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21105413 ↗
• MalfunctionNov 28, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A DEBRIDEMENT DUE TO FACIAL CONTUSION, WHEN THE DERMATOLOGIST USED A NEEDLE HOLDER TO CLAMP THE NEWLY OPENED NON-ABSORBABLE SINGLE-STRAND POLYPROPYLENE SUTURE, THE NEEDLE OF THE SUTURE BROKE ON THE SURGICAL DRAPE. THE DOCTOR REPLACED IT AND COMPLETED THE SUTURING. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 20806029 ↗
• MalfunctionOct 14, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A THIGH LYMPH NODE RESECTION, THE SUTURE BROKE WHILE TYING THE KNOT AFTER SUTURING THE BLOOD VESSEL. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20443232 ↗
• MalfunctionAug 8, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING THE DOUBLE EYELID PLASTIC SURGERY, WHEN USING THE SURGICAL SUTURE TO SUTURE THE SKIN, THE SUTURE NEEDLE BROKE. SINCE THE SUTURE NEEDLE WAS TOO THIN AND SMALL IT WAS NOT EASY TO FIND AFTER BROKEN WHICH PROLONGED THE PERIOPERATIVE PERIOD, INCREASE THE PAIN OF THE PATIENT, AND REDUCE THE PATIENT'S MEDICAL EXPERIENCE. THE SURGEON IMMEDIATELY LOOKED FOR THE NEEDLE, AND AFTER FINDING IT, IT WAS GUARANTEED THAT THE NEEDLE WAS COMPLETELY COMBINED WITHOUT INCOMPLETENESS. THE BROKEN NEEDLE FELL DID NOT FELL OFF INTO ANY PATIENT CAVITY.

  Patient problems: Pain

  MAUDE report 17481293 ↗
• InjuryDec 27, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING PLASTIC SURGERY, THE NEEDLES ON BOTH ENDS OF THE SUTURE BROKE. X-RAYS WERE NEEDED TO DETERMINE THE LOCATION OF THE BROKEN NEEDLE AND THE DOCTOR REMOVED THE BROKEN NEEDLE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 16052714 ↗
• InjuryNov 17, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE PATIENT, DURING A PLASTIC SURGERY, WHEN THE FOREHEAD SKIN WAS SUTURED, THE NEEDLE WAS BROKEN AND FELL INTO THE TISSUE. THE DOCTOR USED COMPUTED TOMOGRAPHY (CT) TO RETRIEVE THE BROKEN NEEDLE AND TAKE IT OUT. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM.

  Patient problems: Unintended Radiation Exposure; Unspecified Tissue Injury

  MAUDE report 15814331 ↗
• MalfunctionNov 11, 2022Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHEN THE DOCTOR SUTURED THE WOUND WITH NYLON SUTURE FOR THE PATIENT, THE NEEDLE BROKE AND WAS REPLACED IMMEDIATELY. THE SURGERY TIME WAS DELAYED DUE TO THE ISSUE.

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

  MAUDE report 15785450 ↗
• MalfunctionMar 11, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING FLAP TRANSPLANT, THE NEEDLE BROKE. A NEW SUTURE 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 13736580 ↗
• MalfunctionMar 2, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING BENIGN SKIN TUMOR RESECTION, WHEN THE SKIN WAS SUTURED AFTER THE OPERATION, THE SUTURE WAS BROKEN. A NEW SUTURE OF THE SAME TYPE WAS IMMEDIATELY USED TO RESOLVE THE ISSUE AND COMPLETE THE OPERATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13654248 ↗
• MalfunctionDec 9, 2021Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A DOUBLE EYELID SURGERY, THE NEEDLE BROKE. ANOTHER SUTURE WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12968941 ↗
• MalfunctionDec 9, 2021Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE BROKE. ANOTHER SUTURE WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12968937 ↗
• MalfunctionDec 3, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING EYELID POUCH AND DOUBLE EYELID SURGERY, WHILE ON A CONTINUOUS INTRADERMAL SUTURE, THE NEEDLE BROKE. ANOTHER SUTURE WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12927070 ↗
• MalfunctionDec 1, 2021Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHEN THE DOCTOR WAS SUTURING THE WOUND OF THE PATIENT, THE NEEDLE OF THE SUTURE BROKE.

  Patient problems: Insufficient Information

  MAUDE report 12913657 ↗
• MalfunctionNov 17, 2021Break; Break

  ACCORDING TO THE REPORTER, WHILE SUTURING THE WOUND DURING AN OPEN DOUBLE EYELID SURGERY, THE NEEDLE BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12827582 ↗
• InjuryNov 16, 2021Break; Product Quality Problem; Dull, Blunt; Detachment of Device or Device Component; Human-Device Interface Problem; Break; Product Quality Problem; Dull, Blunt; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE NEEDLE DEFORMS AND SEPARATES FROM THE THREAD. THE SHAPE OF THE NEEDLE ROTATES IN THE NEEDLE HOLDER. THE NEEDLE ALSO QUICKLY BECOMES BLUNT ESPECIALLY IN CALCIFIED VESSELS. THE SUTURE BREAKS DURING SUTURING AND TYING KNOTS. THE THREAD DOES NOT PULL THROUGH THE TISSUES AS SMOOTHLY. THERE WAS ALSO A NEEDLE HOLE BLEEDING WHEN USING SYNTHETIC GRAFTS WHICH PROLONGS THE OPERATING TIME WAITING FOR HAEMOSTASIS. THERE IS A MISMATCH BETWEEN THE SUTURE AND THE NEEDLE¿S DIAMETER WHICH LEAVES A LARGER HOLE THAN THE THREAD AND BLEEDING THROUGH THE HOLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Unspecified Tissue Injury

  MAUDE report 12819457 ↗
• MalfunctionNov 10, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON AN OPEN DOUBLE EYELID PLASTIC SURGERY, DURING THE FINE SUTURE WOUND, WHILE USING THE CONTINUOUS SUTURE TECHNIQUE, THE NEEDLE BROKE. ANOTHER DEVICE WAS USED RE-SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787905 ↗
• MalfunctionJul 28, 2021Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE SUTURE WAS FOUND BROKEN WHEN UNPACKING. ADDITIONAL DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12238342 ↗
• MalfunctionMay 4, 2021Break; Break

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, DURING PREPARATION ON SHUNT CONSTRUCTION, THE TWO NEEDLES BROKE IN A ROW. THE NEEDLE TIP WAS ABLE TO BE FOUND AND DID NOT CAUSE ANY PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11772570 ↗
• MalfunctionMar 10, 2021Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHEN TAKEN OUT OF THE PACKAGE, 4 SUTURES FROM THE SAME LOT NUMBER HAD BROKEN STRAND. ANOTHER SUTURE WITH DIFFERENT LOT NUMBER 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 11458042 ↗
• MalfunctionSep 10, 2020Break; Break

  ACCORDING TO THE REPORTER, WHEN PUTTING TENSION ON THE THREAD WHEN OVER-LOCKING DURING AN OPEN CAROTID VALVE STITCHING, THE THREAD BROKE CLOSE TO THE NEEDLE. ANOTHER THREAD WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10516503 ↗
• MalfunctionJul 22, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A CAROTID CASE, WHILE PUTTING TENSION ON THE THREAD DURING OVER-LOCKING, THE THREAD ON THE TWO DEVICES BROKE LENGTHWISE AND NOT WHEN INSERTED ON THE NEEDLE. THE SURGEON RETOOK THE SUTURING WITH A NEW THREAD. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10310821 ↗
• MalfunctionJul 22, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A CAROTID CASE, WHILE PUTTING TENSION ON THE THREAD DURING OVER-LOCKING, THE THREAD ON THE TWO DEVICES BROKE LENGTHWISE AND NOT WHEN INSERTED ON THE NEEDLE. THE SURGEON RETOOK THE SUTURING WITH A NEW THREAD. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10310790 ↗
• InjuryMar 9, 2020Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING A VALVE SURGERY, IN THE MIDDLE AND THE END OF THE PROCEDURE, THE NEEDLE AND THREAD BROKE ON THE FOUR DEVICES. THE SURGICAL TIME WAS EXTENDED BY THIRTY MINUTES OR MORE. THE INCISION WAS EXTENDED BY MORE THAN 2.54CM. THE STITCH MEMORY WAS OUT OF THE PACKAGE WITH DEFECTIVE MEMORY. THE PRODUCTS HAVE BEEN CHANGED TO COMPLETE THE CASE.

  Patient problems: No Code Available

  MAUDE report 9809196 ↗
• MalfunctionSep 29, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN SURGERY, THE THREADS BROKE ON 5 SUTURES. ANOTHER SUTURE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9132592 ↗