PRONOVA PN3720HRecalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031246263), received between Oct 18, 2022 and Dec 5, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 5, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC KIDNEY TRANSPLANT PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A ROBOTIC KIDNEY TRANSPLANT PROCEDURE, THE SALES REPRESENTATIVE REPORTED THAT THE SUTURE WAS USED TO ANASTOMOSE THE RENAL VEIN. MIDWAY THROUGH THE ANASTOMOSIS, THE SUTURE BROKE. THERE WERE NO REPORTED PATIENT CONSEQUENCES. THE DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23729961 ↗MalfunctionOct 18, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS FOUND THAT THERE WAS A FOREIGN SUBSTANCE IN THE STERILE PACKAGE BEFORE OPENING THE PACKAGE. THUS, THE PRODUCT WAS NOT USED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15629676 ↗
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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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