PRONOVA PN3557HRecalls & 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
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031246164), received between Apr 19, 2023 and Oct 8, 2024 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Material Separation” (11 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
- Material Separation11
Patient problems
- No Clinical Signs, Symptoms or Conditions11
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 8, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A HEPATO-BILIARY-PANCREATIC SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING A HEPATO-BILIARY-PANCREATIC SURGERY, THE NEEDLES HAD BEEN DETACHED FROM THE SUTURES SEVERAL TIMES. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20396580 ↗MalfunctionOct 8, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A HEPATO-BILIARY-PANCREATIC SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING A HEPATO-BILIARY-PANCREATIC SURGERY, THE NEEDLES HAD BEEN DETACHED FROM THE SUTURES SEVERAL TIMES. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20396572 ↗MalfunctionOct 8, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A HEPATO-BILIARY-PANCREATIC SURGERY ON 24-SEPT2024 AND SUTURE WAS USED. DURING A HEPATO-BILIARY-PANCREATIC SURGERY, THE NEEDLES HAD BEEN DETACHED FROM THE SUTURES SEVERAL TIMES. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20396569 ↗MalfunctionOct 8, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A HEPATO-BILIARY-PANCREATIC SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING A HEPATO-BILIARY-PANCREATIC SURGERY, THE NEEDLES HAD BEEN DETACHED FROM THE SUTURES SEVERAL TIMES. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20396563 ↗MalfunctionOct 8, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A HEPATO-BILIARY-PANCREATIC SURGERY ON (B)(6)2024 AND SUTURE WAS USED. DURING A HEPATO-BILIARY-PANCREATIC SURGERY, THE NEEDLES HAD BEEN DETACHED FROM THE SUTURES SEVERAL TIMES. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20396549 ↗MalfunctionOct 8, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A HEPATO-BILIARY-PANCREATIC SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING A HEPATO-BILIARY-PANCREATIC SURGERY, THE NEEDLES HAD BEEN DETACHED FROM THE SUTURES SEVERAL TIMES. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20396525 ↗MalfunctionOct 8, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A HEPATO-BILIARY-PANCREATIC SURGERY ON (B)(6)2024 AND SUTURE WAS USED. DURING A HEPATO-BILIARY-PANCREATIC SURGERY, THE NEEDLES HAD BEEN DETACHED FROM THE SUTURES SEVERAL TIMES. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20396514 ↗MalfunctionOct 8, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A HEPATO-BILIARY-PANCREATIC SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING A HEPATO-BILIARY-PANCREATIC SURGERY, THE NEEDLES HAD BEEN DETACHED FROM THE SUTURES SEVERAL TIMES. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20396497 ↗MalfunctionOct 8, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A HEPATO-BILIARY-PANCREATIC SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING A HEPATO-BILIARY-PANCREATIC SURGERY, THE NEEDLES HAD BEEN DETACHED FROM THE SUTURES SEVERAL TIMES. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20396481 ↗MalfunctionOct 8, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A HEPATO-BILIARY-PANCREATIC SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING A HEPATO-BILIARY-PANCREATIC SURGERY, THE NEEDLES HAD BEEN DETACHED FROM THE SUTURES SEVERAL TIMES. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20396442 ↗MalfunctionApr 19, 2023Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE UNKNOWN SURGERY, THE NEEDLE EASILY DESWAGED WHILE BEING USED ON THE AORTA. THERE WAS NO TENSION ON THE NEEDLE WHEN IT DESWAGED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16769562 ↗
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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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