PRONOVA D10114Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705031203396), received between Jun 18, 2019 and Dec 31, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2025Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE DEVICES BROKE EASILY. THEY ARE FRAGILE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23935422 ↗
• MalfunctionDec 30, 2025Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE DEVICES BROKE EASILY. THEY ARE FRAGILE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23926212 ↗
• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE FINAL TYING OF AN UNKNOWN CARDIOVASCULAR SURGERY, THE SUTURE IN THE MIDDLE WAS BROKEN DURING USE, NOT AT THE KNOT PART. SINCE THE SAME ISSUE OCCURRED SEVERAL TIMES, THE DOCTOR REQUESTED AN INVESTIGATION TO SEE IF THE SAME ISSUE OCCURRED IN OTHER PRODUCTS FROM THE SAME LOT. BOTH PN3556H AND D10114 ARE NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. LOT NUMBER ¿ 106130 FOR PN3556H, AND 10795H FOR D10114 - UNKNOWN IF THESE ARE THE CORRECT LOT NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23924682 ↗
• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE FINAL TYING OF AN UNKNOWN CARDIOVASCULAR SURGERY, THE SUTURE IN THE MIDDLE WAS BROKEN DURING USE, NOT AT THE KNOT PART. SINCE THE SAME ISSUE OCCURRED SEVERAL TIMES, THE DOCTOR REQUESTED AN INVESTIGATION TO SEE IF THE SAME ISSUE OCCURRED IN OTHER PRODUCTS FROM THE SAME LOT. BOTH PN3556H AND D10114 ARE NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. LOT NUMBER ¿ 106130 FOR PN3556H, AND 10795H FOR D10114 - UNKNOWN IF THESE ARE THE CORRECT LOT NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23924666 ↗
• MalfunctionSep 12, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE DURING CONTINUOUS SUTURING. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT IN ANOTHER LOT NUMBER WAS USED WITH NO PROBLEM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9007662 ↗
• MalfunctionSep 12, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE DURING CONTINUOUS SUTURING. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT IN ANOTHER LOT NUMBER WAS USED WITH NO PROBLEM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9007660 ↗
• MalfunctionSep 12, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE DURING CONTINUOUS SUTURING. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT IN ANOTHER LOT NUMBER WAS USED WITH NO PROBLEM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9007656 ↗
• MalfunctionJun 18, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS FRAYED AND BROKE. THE SURGEON COMMENTED THAT HE FELT UNUSUAL FEELING IN USING OBVIOUSLY THOUGH IT WAS USED AS USUAL. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8707501 ↗
• MalfunctionJun 18, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS FRAYED AND BROKE. THE SURGEON COMMENTED THAT HE FELT UNUSUAL FEELING IN USING OBVIOUSLY THOUGH IT WAS USED AS USUAL. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8707500 ↗
• MalfunctionJun 18, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS FRAYED AND BROKE. THE SURGEON COMMENTED THAT HE FELT UNUSUAL FEELING IN USING OBVIOUSLY THOUGH IT WAS USED AS USUAL. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8707497 ↗