PRONOVA PN3741LGRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031238374), received between Jun 20, 2019 and Aug 21, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING LITA-LAD ANASTOMOSIS. THE BROKEN SUTURE WAS TIED OFF AND A NEW SUTURE WAS USED TO CONTINUE, BUT SUTURE BREAKAGE OCCURRED AGAIN. SUTURES BROKE 3 TIMES IN TOTAL, BUT THE ANASTOMOSIS WAS SOMEHOW COMPLETED. NO PROBLEM WITH THE PATIENT¿S CONDITION NOW. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THE PRODUCTS WERE USED ON BLOOD VESSEL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17585732 ↗
• MalfunctionAug 21, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2023AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING LITA-LAD ANASTOMOSIS. THE BROKEN SUTURE WAS TIED OFF AND A NEW SUTURE WAS USED TO CONTINUE, BUT SUTURE BREAKAGE OCCURRED AGAIN. SUTURES BROKE 3 TIMES IN TOTAL, BUT THE ANASTOMOSIS WAS SOMEHOW COMPLETED. NO PROBLEM WITH THE PATIENT¿S CONDITION NOW. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THE PRODUCTS WERE USED ON BLOOD VESSEL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17584796 ↗
• MalfunctionAug 21, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING LITA-LAD ANASTOMOSIS. THE BROKEN SUTURE WAS TIED OFF AND A NEW SUTURE WAS USED TO CONTINUE, BUT SUTURE BREAKAGE OCCURRED AGAIN. SUTURES BROKE 3 TIMES IN TOTAL, BUT THE ANASTOMOSIS WAS SOMEHOW COMPLETED. NO PROBLEM WITH THE PATIENT¿S CONDITION NOW. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THE PRODUCTS WERE USED ON BLOOD VESSEL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17584795 ↗
• MalfunctionJun 20, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE BROKE. A LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8719577 ↗
• MalfunctionJun 20, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE BROKE. A LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8719569 ↗
• MalfunctionJun 20, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE BROKE. A LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8719567 ↗
• MalfunctionJun 20, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE BROKE. A LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8719561 ↗
• MalfunctionJun 20, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE BROKE. A LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8719559 ↗