Velosorb Fast CV-606Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521152304), received between Mar 26, 2025 and Mar 26, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (7 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE PERINEAL TEARS IN THE DELIVERY ROOM, THE SUTURE LINE DID NOT HOLD DURING THE INITIAL OPERATION RECOVERY ADMISSION, WHICH WAS ALLEGED TO HAVE CAUSED INFECTIONS. THE SUTURES INVOLVED WERE IDENTIFIED AS VELOSORB* 2-0 UND 90CM GS25 X36 AND VELOSORB* 2-0 UND 90CM KV34 X36. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE."

  Patient problems: Unspecified Infection

  MAUDE report 21699271 ↗
• MalfunctionMar 26, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE EPISIOTOMY IN THE DELIVERY ROOM, THE SUTURE LINE DID NOT HOLD 4 DAYS POSTOPERATIVELY, WHICH WAS ALLEGED TO HAVE CAUSED INFECTIONS. THE SUTURES INVOLVED WERE IDENTIFIED AS VELOSORB* 2-0 UND 90CM GS25 X36 AND VELOSORB* 2-0 UND 90CM KV34 X36. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE."

  Patient problems: Unspecified Infection

  MAUDE report 21699267 ↗
• MalfunctionMar 26, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE EPISIOTOMY AND PERINEAL TEARS IN THE DELIVERY ROOM, THE SUTURE LINE DID NOT HOLD 3 DAYS POST-OPERATIVELY, WHICH WAS ALLEGED TO HAVE CAUSED INFECTIONS. THE SUTURES INVOLVED WERE IDENTIFIED AS VELOSORB* 2-0 UND 90CM GS25 X36 AND VELOSORB* 2-0 UND 90CM KV34 X36. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE."

  Patient problems: Unspecified Infection

  MAUDE report 21699250 ↗
• MalfunctionMar 26, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE PERINEAL TEARS IN THE DELIVERY ROOM, THE SUTURE LINE DID NOT HOLD 9 DAYS POSTOPERATIVELY, WHICH WAS ALLEGED TO HAVE CAUSED INFECTIONS. THE SUTURES INVOLVED WERE IDENTIFIED AS VELOSORB* 2-0 UND 90CM GS25 X36 AND VELOSORB* 2-0 UND 90CM KV34 X36. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE."

  Patient problems: Unspecified Infection

  MAUDE report 21699247 ↗
• MalfunctionMar 26, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING THE PERINEAL TEARS IN THE DELIVERY ROOM, THE SUTURE LINE DID NOT HOLD 12 DAYS POSTOPERATIVELY, WHICH WAS ALLEGED TO HAVE CAUSED INFECTIONS. THE SUTURES INVOLVED WERE IDENTIFIED AS VELOSORB* 2-0 UND 90CM GS25 X36 AND VELOSORB* 2-0 UND 90CM KV34 X36. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE."

  Patient problems: Unspecified Infection

  MAUDE report 21699239 ↗
• MalfunctionMar 26, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT IN THE DELIVERY ROOM, THE SUTURE LINE DID NOT HOLD POST-OPERATIVELY, WHICH WAS ALLEGED TO HAVE CAUSED INFECTIONS. THE SUTURES INVOLVED WERE IDENTIFIED AS VELOSORB* 2-0 UND 90CM GS25 X36 AND VELOSORB* 2-0 UND 90CM KV34 X36."

  Patient problems: Unspecified Infection

  MAUDE report 21699234 ↗
• MalfunctionMar 26, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT IN THE DELIVERY ROOM, THE SUTURE LINE DID NOT HOLD POST-OPERATIVELY, WHICH WAS ALLEGED TO HAVE CAUSED INFECTIONS. THE SUTURES INVOLVED WERE IDENTIFIED AS VELOSORB* 2-0 UND 90CM GS25 X36 AND VELOSORB* 2-0 UND 90CM KV34 X36."

  Patient problems: Unspecified Infection

  MAUDE report 21699220 ↗

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-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-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-0024-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" CV-25 Taper, Product Number: CV3100, UDI: 20884521150901 - Product Usage: indicated for use in soft tis
• 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-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 tis
• Z-0014-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" C-12 Cutting, Product Number: SV2294, UDI 20884521151403 - Product Usage: indicated for use in soft tissu
• Z-0012-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting, Product Number: SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissu
• 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
• 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-0041-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" PC-11 SV487G, UDI: 10884521149595 - Product Usage: indicated for use in soft tissue approximation of the
• 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
• Z-0023-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 30" P-10 Cutting, Product Number: SV4893, UDI: 20884521151717 - Product Usage: indicated for use in soft ti
• 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 ap
• 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

…and 26 more.