PRONOVA PN3556HRecalls & reported problems
Ethicon, LLC · Blue Monofilament Poly(Hexafluoropropylene-VDF), Nonabsorbable Surgical Suture · Class 2 · Implant
All models of PRONOVA (27)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031238336), received between Sep 28, 2023 and Dec 30, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 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.
Reports received per month
Most reported problems
Device problems
- Break4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
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 23924674 ↗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 23924662 ↗MalfunctionFeb 22, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE STRAND OF THE SUTURE WAS CUT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18759625 ↗MalfunctionSep 28, 2023Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS CUT DURING SURGERIES AND THEN IT WAS DISCARDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17833826 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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