Velosorb Fast CV-945Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521151208), received between Jun 27, 2018 and Jul 24, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, "POSTOPERATIVE TO EPISIOTOMY, WOUND DEHISCENCE WAS OBSERVED."

  Patient problems: Wound Dehiscence

  MAUDE report 10323006 ↗
• MalfunctionJun 27, 2018Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, THERE WAS A BREAKDOWN OF WOUND CLOSURE THAT OCCURRED AFTER A REPAIR OF EPISIOTOMY WAS COMPLETED.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient; Wound Dehiscence

  MAUDE report 7642861 ↗

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-0037-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-11 Cutting CV4731, UDI: 20884521151359 - Product Usage: indicated for use in soft tissue approximation
• Z-0010-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - Product Usage: indicated for use in soft tissu
• 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 tissu
• Z-0016-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-14 Cutting, Product Number: SV6830, UDI: 20884521152349 - Product Usage: indicated for use in soft tiss
• Z-0028-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" CV-23 Taper, Product Number: CV1213, UDI: 20884521150758 - Product Usage: indicated for use in soft tis
• 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-0025-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-12 Cutting, Product Number: SV496G, UDI: 20884521149691 - Product Usage: indicated for use in soft ti
• Z-0013-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" KV-34 TaperCutting, Product Number: CV919, UDI: 20884521151649 - Product Usage: indicated for use in soft
• 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-0047-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" CV-25 Taper CV3110, UDI: 20884521150918 - Product Usage: indicated for use in soft tissue approximation o
• 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 approximati
• 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 a
• Z-0034-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-25, Product Number: CV605, UDI: 20884521152295 - Product Usage: indicated for use in soft tissue appro
• Z-0044-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-12 Cutting SV497G, UDI: 20884521149707 - Product Usage: indicated for use in soft tissue approximation

…and 26 more.