Velosorb Fast SV-2297Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521150959), received between Nov 15, 2021 and Nov 15, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

41 other recalls cover devices cleared under the same FDA submission (K120556); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2021Break; Break

  ACCORDING TO THE REPORTER, "THE NEEDLE CAME LOOSE OF THE SUTURE."

  Patient problems: Insufficient Information

  MAUDE report 12812533 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120556. One submission often covers many models, so check the product and lot details in each record.

• Z-0949-2021 · Dec 9, 2020 · Terminated
  Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307
• Z-0019-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-11, Product Number: SVP2294, UDI: 20884521177403 - Product Usage: indicated for use in soft tissue appr
• Z-0026-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" V-20 Taper, Product Number: CV416G, UDI: 20884521149363 - Product Usage: indicated for use in soft tissue
• Z-0015-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30" V-20 Taper, Product Number: CV417G, UDI: 20884521149370 - Product Usage: indicated for use in soft tissue
• Z-0027-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-21 Taper, Product Number: CV947, UDI: 20884521153056 - Product Usage: indicated for use in soft tissue a
• Z-0018-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" CV-25 Taper, Product Number: CV3110, UDI: 20884521150918 - Product Usage: indicated for use in soft tissu
• Z-0049-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" C-13 Cutting SV2298, UDI: 20884521151021 - Product Usage: indicated for use in soft tissue approximation
• Z-0031-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" KV-11, TaperCutting, Product Number: CV2293, UDI: 20884521151588 - Product Usage: indicated for use in so
• Z-0043-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" KV-15 TaperCutting CV2279, UDI: 20884521151632 - Product Usage: indicated for use in soft tissue approxim
• Z-0042-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-25 CV605, UDI: 20884521152295 - Product Usage: indicated for use in soft tissue approximation of the sk
• Z-0035-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" C-12 Cutting, Product Number: SV2295, UDI: 20884521151397 - Product Usage: indicated for use in soft tiss
• Z-0032-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" PC-10, Product Number: SV835G, UDI: 20884521149721 - Product Usage: indicated for use in soft tissue appr
• Z-0033-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 36" KV-34, TaperCutting Product Number: CV916, UDI: 20884521153032 - Product Usage: indicated for use in soft
• Z-0040-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation
• Z-0039-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-25 CV604, UDI: 20884521152288 - Product Usage: indicated for use in soft tissue approximation of the sk

…and 26 more.