Surgipro II VP-754-XRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10884521039032), received between Mar 29, 2021 and May 24, 2024 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 24, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN HYPOSPADIAS PROCEDURE, THE NEEDLE BROKE ON TWO SUTURES. A NEW SUTURE WITH A DIFFERENT LOT NUMBER WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397943 ↗
• MalfunctionMay 23, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN HYPOSPADIAS PROCEDURE, THE NEEDLE BROKE ON TWO SUTURES. A NEW SUTURE WITH A DIFFERENT LOT NUMBER WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19387996 ↗
• MalfunctionNov 28, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING OPERATION, THE PRODUCT PACKAGING WAS INTACT AND THE NEEDLE BROKE. AFTER REPLACEMENT, IT BROKE AGAIN.

  Patient problems: Insufficient Information

  MAUDE report 18219576 ↗
• MalfunctionNov 28, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING OPERATION, THE PRODUCT PACKAGING WAS INTACT AND THE NEEDLE BROKE. AFTER REPLACEMENT, IT BROKE AGAIN.

  Patient problems: Insufficient Information

  MAUDE report 18219504 ↗
• MalfunctionNov 20, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A PEDIATRIC ANTHROMBUS PROCEDURE, DIRECTOR ROUTINELY USED SUTURE TO PERFORM SIMPLE CONTINUOUS SUTURES ON THE VENTRICULAR DEFECT REPAIR SURGERY. AFTER ONE STITCH WAS SEWN, THE NEEDLE BROKE WHEN THE NEEDLE WAS HELD IN THE MIDDLE AND REAR 1/3 POSITION WITH A PEN-TYPE NEEDLE HOLDER ON THE OPERATING TABLE. THE PRODUCT WAS REPLACED AND SEWED AGAIN, SEWED HALFWAY, AND THE NEEDLE BROKE AGAIN WHEN PASSING THROUGH THE TISSUE. REPLACED WITH THE THIRD PRODUCT AND CONTINUED SEWING TO COMPLETE. AFTER THE THIRD SEWING WAS COMPLETED, WHEN TYING THE KNOT, IT WAS FOUND THAT STRIPED APPLIER (WITH RUBBER PROTECTIVE SLEEVE), HOLDING AND CLAMPING SIDE, THE NEEDLE TAIL FELT WAS NOT HELD AND CLAMPED. ALL THREE NEEDLES BROKE AND NOTHING FELL IN PATIENT CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18174733 ↗
• MalfunctionNov 20, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A PEDIATRIC ANTHROMBUS PROCEDURE, DIRECTOR ROUTINELY USED SUTURE TO PERFORM SIMPLE CONTINUOUS SUTURES ON THE VENTRICULAR DEFECT REPAIR SURGERY. AFTER ONE STITCH WAS SEWN, THE NEEDLE BROKE WHEN THE NEEDLE WAS HELD IN THE MIDDLE AND REAR 1/3 POSITION WITH A PEN-TYPE NEEDLE HOLDER ON THE OPERATING TABLE. THE PRODUCT WAS REPLACED AND SEWED AGAIN, SEWED HALFWAY, AND THE NEEDLE BROKE AGAIN WHEN PASSING THROUGH THE TISSUE. REPLACED WITH THE THIRD PRODUCT AND CONTINUED SEWING TO COMPLETE. AFTER THE THIRD SEWING WAS COMPLETED, WHEN TYING THE KNOT, IT WAS FOUND THAT STRIPED APPLIER (WITH RUBBER PROTECTIVE SLEEVE), HOLDING AND CLAMPING SIDE, THE NEEDLE TAIL FELT WAS NOT HELD AND CLAMPED. ALL THREE NEEDLES BROKE AND NOTHING FELL IN PATIENT CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18174651 ↗
• MalfunctionOct 31, 2023Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A GENERAL SURGERY, WHEN SUTURING THE WOUND, THE NEEDLE BROKE. THE SURGICAL TIME WAS AFFECTED. ANOTHER DEVICE FROM ANOTHER BOX WAS USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18044691 ↗
• MalfunctionJul 3, 2023Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ON ATRIOVENTRICULAR SEPTAL DEFECT (AVSD) CARDIOPULMONARY BYPASS (CPB) EXTRACORPOREAL CIRCULATION, WHILE SEWING THE ATRIUM IN AND CLOSING THE DEFECT, WHILE SUTURING A 0.4MM (MILLIMETER) PATCH FROM ANOTHER MANUFACTURER, THE NEEDLES OF 4 SUTURES BROKE. A DIFFERENT SUTURE WAS THEN TAKEN, BUT NEEDLES OF 2 SUTURES BROKE AS WELL. THE BROKEN PARTS OF THE NEEDLES WHERE FALLING TO THE HEART. EACH TIME THE NEEDLE BROKE, IT WAS TAKEN OUT FROM THE CAVITY OR THE SURFACE OF THE HEART AND WAS CHECKED ON THE INSTRUMENTAL TABLE IF ALL PIECES CAN BE PUT TO ONE NEEDLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE SURGICAL TIME WAS EXTENDED FOR 30 MINUTES OR MORE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17247433 ↗
• MalfunctionSep 2, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PANCREATICODUODENECTOMY, WHILE SUTURING AT PANCREATICOJEJUNOSTOMY, THE NEEDLE BROKE WHEN IT WAS APPLIED TO THE PANCREAS AT THE 5TH STITCH OF THE CONTINUOUS SUTURE. THE NEEDLE DID NOT FALL INSIDE THE BODY, AND IT WAS RETRIEVED IMMEDIATELY. THE OPERATION WAS COMPLETED SUCCESSFULLY AFTER A NEW THREAD WAS TAKEN OUT AND ANASTOMOSIS WAS PERFORMED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15348875 ↗
• MalfunctionDec 30, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN HEART SURGERY ON A CHILD, WHEN SUTURING, THE NEEDLE BROKE, THE SURGEON TOOK ANOTHER SUTURE FROM A DIFFERENT BOX AND LOT AND IT BROKE AGAIN. IT WAS NOTED A PART FELL INTO THE PATIENT CAVITY AND WAS RETRIEVED WITH A NEEDLE HOLDER. THE USER IMMEDIATELY REMOVED THE 2 BOXES THAT HAD THE ISSUE AND CALLED THE DISTRIBUTOR WHICH IMMEDIATELY DELIVERED 2 NEW BOXES OF SUTURES WITH OTHER LOTS THAN THE OPERATOR HAD, AND SO FAR THERE HAVE BEEN NO PROBLEMS. IT WAS NOT KNOWN IF THE THIRD SUTURE WAS FROM THE SAME BOX OR A THIRD BOX WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13119364 ↗
• MalfunctionDec 30, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN HEART SURGERY ON A CHILD, WHEN SUTURING, THE NEEDLE BROKE, THE SURGEON TOOK ANOTHER SUTURE FROM A DIFFERENT BOX AND LOT AND IT BROKE AGAIN. IT WAS NOTED A PART FELL INTO THE PATIENT CAVITY AND WAS RETRIEVED WITH A NEEDLE HOLDER. THE USER IMMEDIATELY REMOVED THE 2 BOXES THAT HAD THE ISSUE AND CALLED THE DISTRIBUTOR WHICH IMMEDIATELY DELIVERED 2 NEW BOXES OF SUTURES WITH OTHER LOTS THAN THE OPERATOR HAD, AND SO FAR THERE HAVE BEEN NO PROBLEMS. IT WAS NOT KNOWN IF THE THIRD SUTURE WAS FROM THE SAME BOX OR A THIRD BOX WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13119315 ↗
• MalfunctionDec 28, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN CORONARY ARTERY BYPASS GRAFT SURGERY, WHEN THE PROXIMAL BLOOD VESSEL WAS ANASTOMOSED, THE NEEDLE WAS BROKEN WHILE USING A CONTINUOUS SUTURING TECHNIQUE. THE BROKEN PART OF THE NEEDLE WAS THEN LOCATED BY THE SURGEON AND THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES OR MORE. A NEW SUTURE WAS USED RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13095117 ↗
• MalfunctionSep 15, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON ATRIOVENTRICULAR SEPTAL DEFECT (AVSD), WHILE SEWING THE ATRIUM IN AND CLOSING THE DEFECT, WHILE SUTURING A PATCH, THE NEEDLES OF 4 SUTURES BROKE. A DIFFERENT SUTURE WAS THEN TAKEN, BUT NEEDLES OF 2 SUTURES BROKE AS WELL. THE BROKEN PARTS OF THE NEEDLES WHERE FALLING TO THE HEART. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE SURGICAL TIME WAS EXTENDED FOR 30 MINUTES OR MORE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12475773 ↗
• MalfunctionJun 9, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING VASCULAR ANASTOMOSIS ON AN OPEN CORONARY ARTERY BYPASS GRAFT, THE NEEDLE BROKE WHILE USING A CONTINUOUS SUTURING TECHNIQUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971460 ↗
• MalfunctionJun 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE'S NEEDLE AND THREAD FOUND DETACHED UPON OPENING THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11914557 ↗
• MalfunctionMar 29, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING A HEART SURGERY, THE NEEDLE BROKE ON TWO SUTURE DEVICES. THE SURGEON LOOKED FOR THE NEEDLE TIP TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11585557 ↗