Surgipro ll VP-705-XRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521038233), received between Jun 27, 2018 and Aug 25, 2021 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2021Material Frayed; Unraveled Material; Material Frayed; Unraveled Material

  ACCORDING TO THE REPORTER, DURING REEFING OF THE DEFECTIVE PART OF VENTRICULAR SEPTAL DEFECT, THE THREAD OF 2 SUTURES GOT FRAYED. RE -OPERATION WAS PERFORMED AND A THREAD WITH LOOSE LIGATION WAS FOUND IN THE THORACOTOMY SITE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12367075 ↗
• MalfunctionDec 23, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE TWO THREADS BROKE WHILE THE SURGEON WAS TYING THE KNOT. ANOTHER STRAND WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11063595 ↗
• MalfunctionJun 27, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CORONARY BYPASS PROCEDURE, THE THREAD CAME OFF THE NEEDLE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8741856 ↗
• InjuryDec 12, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE NEEDLE BROKE. THEY TOLD FOR 2 YEARS WE HAVE BEEN IN DIALOGUE WITH SUPPLIER ABOUT PROBLEMS WITH BROKEN AND BENT NEEDLES AND THREADS THAT ALSO BREAK. THEY HAVE RECEIVED 5 UNINTENDED EVENTS WITH NEEDLES THAT HAVE BROKEN DURING A SURGERY. THE POURING DATE IS JUST AN EXAMPLE OF DATE AS THERE HAVE BEEN MANY EVENTS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8155320 ↗
• InjuryDec 12, 2018Break; Detachment of Device or Device Component; Material Twisted/Bent; Break; Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE NEEDLE BROKE. THEY TOLD FOR 2 YEARS WE HAVE BEEN IN DIALOGUE WITH THE SUPPLIER ABOUT PROBLEMS WITH BROKEN AND BENT NEEDLES AND THREADS THAT ALSO BREAK. THEY HAVE RECEIVED 5 UNINTENDED EVENTS WITH NEEDLES THAT HAVE BROKEN DURING A SURGERY. THE POURING DATE IS JUST AN EXAMPLE OF DATE AS THERE HAVE BEEN MANY EVENTS. THEY ALWAYS TRY TO FIND TIPS THAT ARE BROKEN, BUT BECAUSE OF THE VERY SMALL METAL PIECES THAT ARE HARDLY VISIBLE, THERE MAY BE INSTANCES WHERE MICROSCOPIC METAL PIECES ARE LEFT IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 8155285 ↗
• InjuryDec 12, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE NEEDLE BROKE. THEY TOLD FOR 2 YEARS WE HAVE BEEN IN DIALOGUE WITH SUPPLIER ABOUT PROBLEMS WITH BROKEN AND BENT NEEDLES AND THREADS THAT ALSO BREAK. THEY HAVE RECEIVED 5 UNINTENDED EVENTS WITH NEEDLES THAT HAVE BROKEN DURING A SURGERY. THE POURING DATE IS JUST AN EXAMPLE OF DATE AS THERE HAVE BEEN MANY EVENTS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8155076 ↗
• InjuryDec 12, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE NEEDLE BROKE. THEY TOLD FOR 2 YEARS WE HAVE BEEN IN DIALOGUE WITH SUPPLIER ABOUT PROBLEMS WITH BROKEN AND BENT NEEDLES AND THREADS THAT ALSO BREAK. THEY HAVE RECEIVED 5 UNINTENDED EVENTS WITH NEEDLES THAT HAVE BROKEN DURING A SURGERY. THE POURING DATE IS JUST AN EXAMPLE OF DATE AS THERE HAVE BEEN MANY EVENTS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8155033 ↗
• MalfunctionJul 13, 2018Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CORONARY BYPASS PROCEDURE, THE NEEDLE DETACHED FROM THE THREAD WHILE SUTURING THE BLOOD VESSEL. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7685712 ↗
• MalfunctionJun 27, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE NEEDLE BROKE. THE PATIENT'S INVOLVEMENT AND OUTCOME WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7641952 ↗