Velosorb Fast SV-935Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521151758), received between Oct 1, 2020 and Dec 30, 2025 — classified as 3 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2025Dull, Blunt; Dull, Blunt

  ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING A PROCEDURE, THE NEEDLE BECAME BLUNT TOO QUICKLY BEFORE FINISHING SUTURING, NECESSITATING A CHANGE OF THE SUTURE BEFORE THE THREAD WAS USED UP. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23923733 ↗
• MalfunctionAug 25, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  VELOSORB PRODUCTS WERE LABELED AS NON-STERILE AND INTENDED FOR SHIPMENT TO THE CONTRACT STERILIZER BUT WERE INADVERTENTLY SHIPPED TO THE DISTRIBUTOR. PRODUCTS WERE FURTHER DISTRIBUTED TO CUSTOMERS. RIVERPOINT PLACED AN IMMEDIATE HOLD ON MANUFACTURING AND DISTRIBUTION OF THE VELOSORB PRODUCT AND DEVICE RECALL Z-0048-2021 WAS INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12367301 ↗
• MalfunctionOct 1, 2020Break; Break

  ACCORDING TO THE REPORTER, "DURING SECOND DEGREE TEAR REPAIR FROM BIRTHING, WHEN TRYING TO ANCHOR APEX, NEEDLE BROKE AS FINE NEEDLE WHICH IS NOT UTILIZED FOR MUSCLE REPAIR. A NEW SUTURE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10617560 ↗

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-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
• 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-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-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 t
• Z-0048-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation o
• 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-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-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-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-0030-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-14, Product Number: SVP2251, UDI: 20884521177380 - Product Usage: indicated for use in soft tissue appr
• Z-0017-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-24, Product Number: SV9911G, UDI: 20884521149776 - Product Usage: indicated for use in soft tissue appr
• Z-0021-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" SC-1, Product Number: SV2239, UDI: 20884521151779 - Product Usage: indicated for use in soft tissue appro
• 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 tiss
• 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 tissu

…and 26 more.