PRONOVA 3521HRecalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705031004443), received between Jun 17, 2019 and Jun 17, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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.
Most reported problems
Device problems
- Material Separation1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2019Material Separation; Material Separation
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE DURING VASCULAR ANASTOMOSIS BY CONTINUOUS SUTURING. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WERE NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8703856 ↗
Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE devices
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- PROLENE 8556HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death240 reports
- PROLENE 8805HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death209 reports
- PROLENE 8521HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE3 deaths183 reports
- PROLENE 8735HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE163 reports
- PROLENE 8711HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 recall89 reports
- PROLENE 9702HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE130 reports
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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