Surgipro ll VP-901-MXRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10884521039544), received between Dec 21, 2017 and Mar 19, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (10 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.

• MalfunctionMar 19, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE PACKET WAS NOTED TO NOT CONTAIN THE REQUIRED NUMBER OF SUTURES. THERE WAS NO PATIENT INVOLVEMENT. AS THERE WAS NO PROBLEM WITH THE DEVICE ITSELF, THE DEVICE WAS STILL USED. THE MISSING QUANTITY WAS TAKEN OUT ADDITIONALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21641557 ↗
• MalfunctionApr 18, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY LOWER EXTREMITY SHUNT ANASTOMOSIS, THE NEEDLE TIP OF THE TWO DEVICES BROKE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19135567 ↗
• MalfunctionApr 18, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY LOWER EXTREMITY SHUNT ANASTOMOSIS, THE NEEDLE TIP OF THE TWO DEVICES BROKE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19135269 ↗
• MalfunctionMar 23, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A CARDIOVASCULAR SURGERY, WHILE APPLYING THE THREAD TO THE MYOCARDIUM, THE NEEDLE BROKE. A NEW PRODUCT WAS USED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 13867135 ↗
• MalfunctionNov 5, 2020Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CORONARY BYPASS, WHEN THE CENTRAL ANASTOMOSIS WAS PERFORMED, THE NEEDLE CAME OFF THE THREAD WHEN HOLDING THE NEEDLE. ALSO, IT WAS DIFFICULT TO SLIP THE STRING DOWNWARD THAN USUAL. AFTER THAT, A PRODUCT WITH THE SAME LOT NUMBER WAS OPENED AND THE OPERATION WAS COMPLETED SUCCESSFULLY, BUT IT WAS REQUIRED TO CHECK THE NEEDLE AND THREAD COATING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10795792 ↗
• MalfunctionJun 2, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A CORONARY BYPASS THE NEEDLE BROKE IN THE MIDDLE OF THE ANASTOMOSIS. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THE PART FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10109114 ↗
• MalfunctionApr 8, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING CORONARY BYPASS PROCEDURE, THE DEVICE THREAD BROKE. 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 9935930 ↗
• MalfunctionDec 20, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS PROCEDURE, THE NEEDLE WAS HELD BY A NEEDLE HOLDER AND WHEN TRYING TO PULL OUT THE THREAD, THE THREAD BROKE AT A PLACE ABOUT 2 CM. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED ON THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9504068 ↗
• MalfunctionOct 20, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A CORONARY BYPASS, THREAD BREAKAGE OCCURRED WITH TWO PACKETS IN SUCCESSION WHEN USING THE PRODUCTS. ANOTHER DEVICE WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9212526 ↗
• MalfunctionFeb 13, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CORONARY BYPASS PROCEDURE, WHILE SUTURING, THE DEVICE NEEDLE AND THREAD EASILY DISENGAGED TO EACH OTHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8334474 ↗
• MalfunctionFeb 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A CORONARY BYPASS, DURING SUTURING, THE NEEDLE AND THE THREAD OF THE TWO SUTURES USED WERE EASILY DISENGAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8300535 ↗
• MalfunctionFeb 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CORONARY BYPASS SURGERY, WHILE HANDLING THE NEEDLE, THE NEEDLE AND THREADS EASILY DISENGAGED. IT WAS REPORTED THAT NOTHING FELL INTO THE PATIENT'S CAVITY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8298275 ↗
• MalfunctionJul 13, 2018Break; Material Split, Cut or Torn; Break

  ACCORDING TO THE REPORTER, DURING A CORONARY BYPASS PROCEDURE, TWO THREADS WERE TORN OUT CONTINUOUSLY DURING THE ANASTOMOTIC OPERATION OF THE BLOOD VESSEL. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7685186 ↗
• MalfunctionJun 28, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A CORONARY BYPASS, THE NEEDLE BROKE WHILE SEWING. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7648312 ↗
• MalfunctionJan 2, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CORONARY BYPASS PROCEDURE, THE DOCTOR HOOKED THE NEEDLE TO THE GRAFT AND TRIED PULLING IT, THEN THE NEEDLE CAME OFF THE THREAD. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7159014 ↗
• MalfunctionDec 21, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING CORONARY ARTERY BYPASS PROCEDURE, THERE WERE 3 THREADS BROKE. THE SURGEON USED NEW THREAD TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7140858 ↗