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MONOSWIFT L496Recalls & reported problems

C.P. Medical Corporation · Class 2

Data updated Oct 16, 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 10790986001449), received between Dec 1, 2018 and Dec 1, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K072229); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Break4

Patient problems

  • No Known Impact Or Consequence To Patient3
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 1, 2018Break

    IT WAS REPORTED THAT PGCL SUTURES, ASSOCIATED WITH LOT# 171006-63 WERE BREAKING WHILE BEING TIED DOWN. THIS FAILURE OCCURRED WITH 4 PATIENTS BETWEEN THE AGE RANGE OF MID 30S-(B)(6) YEARS OLD AND IN GOOD HEALTH. THERE WERE NO ADVERSE EFFECTS ASSOCIATED WITH PGCL SUTURES. THE SURGERIES WAS DELAYED FOR 1 MINUTE AND FINISHED WITH ANOTHER UNKNOWN SUTURE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8122184 ↗
  • MalfunctionDec 1, 2018Break

    IT WAS REPORTED THAT PGCL SUTURES, ASSOCIATED WITH LOT# 171006-63, WERE BREAKING WHILE BEING TIED DOWN. THIS FAILURE OCCURRED WITH 4 PATIENTS BETWEEN THE AGE RANGE OF MID 30S-(B)(6) AND IN GOOD HEALTH. THERE WERE NO ADVERSE EFFECTS ASSOCIATED WITH PGCL SUTURES. THE SURGERIES WAS DELAYED FOR 1 MINUTE AND FINISHED WITH ANOTHER UNKNOWN SUTURE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8122179 ↗
  • MalfunctionDec 1, 2018Break

    IT WAS REPORTED THAT PGCL SUTURES, ASSOCIATED WITH LOT# 171006-63 WERE BREAKING WHILE BEING TIED DOWN. THIS FAILURE OCCURRED WITH 4 PATIENTS BETWEEN THE AGE RANGE OF (B)(6) AND IN GOOD HEALTH. THERE WERE NO ADVERSE EFFECTS ASSOCIATED WITH PGCL SUTURES. THE SURGERIES WAS DELAYED FOR 1 MINUTE AND FINISHED WITH ANOTHER UNKNOWN SUTURE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8122175 ↗
  • MalfunctionDec 1, 2018Break

    IT WAS REPORTED THAT PGCL SUTURES, ASSOCIATED WITH LOT# 171006-63 WERE BREAKING WHILE BEING TIED DOWN. THIS FAILURE OCCURRED WITH 4 PATIENTS BETWEEN THE AGE RANGE OF MID (B)(6) YEARS OLD AND IN GOOD HEALTH. THERE WERE NO ADVERSE EFFECTS ASSOCIATED WITH PGCL SUTURES. THE SURGERIES WAS DELAYED FOR 1 MINUTE AND FINISHED WITH ANOTHER UNKNOWN SUTURE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8122170 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072229. One submission often covers many models, so check the product and lot details in each record.

  • Z-1872-2017 · Feb 2, 2017 · Open, Classified
    PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes L923, L459, L493, L762, L463, L922, L495, L463, L497, L494,

Other Suture, Absorbable, Synthetic, Polyglycolic Acid devices

All Suture, Absorbable, Synthetic, Polyglycolic Acid devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page