Surgipro VP-523Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521037809), received between Mar 4, 2019 and Jan 9, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

1 other recall cover devices cleared under the same FDA submission (K954808); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE ON SUTURING, THE SUTURE BROKE IN THE MIDDLE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24027268 ↗
• MalfunctionJun 28, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA, CONTINUOUS SUTURE OF THE PERITONEUM, THE THREAD BROKE. RE-STITCH WAS DONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17216597 ↗
• MalfunctionJun 23, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HIGH LIGATION OF AN INGUINAL HERNIA, AFTER USING THE HERNIA- HOOK NEEDLE THROUGH THE 2-0 VASCULAR SUTURE, THE PUNCTURE WAS COMPLETED. WHEN THE PERITONEUM WAS LIFTED AND TIED USING 2-0 VASCULAR SUTURE, THE 2-0 VASCULAR SUTURE SUDDENLY BROKE, RESULTED IN A RE-PUNCTURE. IT INCREASED THE DAMAGED TO THE SURGICAL SITE, PROLONGED THE SURGERY AND ANESTHESIA TIME BY 3 MINUTES. TO RESOLVE THE ISSUE, THE SUTURE WAS REPLACED WITH THE SAME PRODUCT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17195151 ↗
• MalfunctionMay 2, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPENING INGUINAL HERNIA REPAIR, WHEN CLOSING, THE NEEDLE BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16854033 ↗
• MalfunctionNov 17, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE NEWLY OPENED PACKAGE WAS READY FOR THE PATIENT AFTER SURGERY, THE SUTURE WAS FOUND TO BE BROKEN. THE SUTURE WAS NOT USED ON THE PATIENT. A NEW SUTURE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15817740 ↗
• MalfunctionNov 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPY PROCEDURE, THE SURGEON STATED THAT WHILE DOING A REGULAR SURGEONS KNOT, SURGEON HAD ONE NEEDLE POP OFF DURING THE CASE AND FELL INTO PATIENT'S CAVITY BUT WAS RETRIEVED VIA GRASPER. OPERATOR HAD TO OPEN UP THREE ADDITIONAL PACKAGES TO GET A SUTURE WHERE THE NEEDLE DIDN'T POP OFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9280256 ↗
• InjuryJul 2, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING OPEN HERNIA REPAIR, THE TIP OF THE TWO NEEDLES BROKE AND WAS NOT RETRIEVED. AN X-RAY WAS PERFORMED FOR THE EXPRESS PURPOSE OF LOCATING THE NEEDLE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE.

  Patient problems: Device Embedded In Tissue or Plaque; Radiation Exposure, Unintended

  MAUDE report 8753848 ↗
• MalfunctionJun 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ASSISTED-DISTAL GASTRECTOMY PROCEDURE, THE DEVICE THREAD DETACHED FROM THE NEEDLE. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8669049 ↗
• InjuryMar 4, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING REPAIR OF INGUINAL HERNIA WITH MESH PROCEDURE, THE SURGEON INFORMED THE NURSE THAT THE TIP TO HIS SUTURE NEEDLE BROKE OFF. X-RAY TAKEN IMMEDIATELY WITH PORTABLE MACHINE. X-RAY NEGATIVE FOR ANY RETAINED PORTION OF SUTURE. THE BROKEN NEEDLE WAS DISCARDED AND OPENED A NEW NEEDLE.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 8388617 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K954808. One submission often covers many models, so check the product and lot details in each record.

• Z-1179-2023 · Dec 2, 2022 · Open, Classified
  Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU 100CM GS24 X36 CP-824 SURGIPRO* 1 BLU 150CM GS26 X24 CP-825 SURGIPRO* 2 BLU 150CM GS26 X24 VP