PDS D8425Recalls & reported problems
Ethicon, LLC · Violet Monofilament (Polydioxanone), Absorbable Synthetic Surgical Suture · Class 2 · Implant
Data updated Oct 13, 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 10705031030169), received between Aug 8, 2024 and Aug 8, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K183183, N18331); they may or may not involve this specific model.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 8, 2024Break; Break
IT WAS REPORTED A PATIENT UNDERWENT A EXPLORATORY LAPARASCOPY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. DURING PROCEDURE; TIP OF THE NEEDLE BROKE OFF. THERE WAS NO PATIENT CONSEQUENCES. UNKNOWN IF PROCEDURE WAS COMPLETED SUCCESSFULLY. PROCEDURE PROLONGED 15 MINUTES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19942802 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K183183, N18331. One submission often covers many models, so check the product and lot details in each record.
- Z-1513-2025 · Mar 7, 2025 · Open, ClassifiedPDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MP
- Z-0319-2025 · Sep 25, 2024 · Open, ClassifiedCoated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
- Z-2146-2024 · May 10, 2024 · Open, ClassifiedPDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery.
Other SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE devices
- STRATAFIX SXPP1A405Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE617 reports
- STRATAFIX SXPP1A400Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE485 reports
- STRATAFIX SXPP1A401Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE446 reports
- STRATAFIX SXPP1A301Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE443 reports
- STRATAFIX SXPP2B405Ethicon, LLC · Suture, surgical, absorbable, polydioxanone406 reports
- STRATAFIX SXPP1A406Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE339 reports
- STRATAFIX SXPP1A404Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 death319 reports
- STRATAFIX SXPP1B420Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 death229 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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