Surgipro II VP706MX-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521758322), received between Apr 26, 2022 and Aug 5, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A FEMORAL POPLITEAL BYPASS GRAFT PROCEDURE, WHILE SUTURING THE GRAFT, THE SUTURE BROKE IN THE MIDDLE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19912254 ↗
• MalfunctionAug 23, 2023Break; Material Frayed; Adverse Event Without Identified Device or Use Problem; Break; Material Frayed; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFT (CABG), WHILE TYING KNOTS IN PLACE, THE 4-0 DIAMETER SUTURE IS BREAKING AND FRAYING, ANOTHER 4-0 DIAMETER SUTURE WAS USED HOWEVER THE SAME ISSUE OCCURRED. THEY USED A 6-0 DIAMETER HOWEVER THE SAME ISSUE OCCURRED. THERE WAS TISSUE DAMAGE AS THE VEIN THAT WAS HARVESTED HAD TO BE CUT AND RE-SUTURED AT THE ANASTOMOSIS OF THE BYPASS. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM.

  Patient problems: Tissue Breakdown

  MAUDE report 17607790 ↗
• MalfunctionApr 26, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER PRIOR TO USE, THE SUTURE PACK HAS MISSING A STRAND. THERE SHOULD BE TEN NEEDLES, INSTEAD THERE ARE ONLY EIGHT. A DOUBLE ARMED STRAND OF SUTURE IS MISSING FROM THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14215480 ↗

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