Velosorb Fast CV-917Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10884521151659), received between Nov 10, 2017 and Mar 26, 2025 — classified as 5 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 20 most recent of 20 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 21699289 ↗
• 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 21699266 ↗
• 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 21699252 ↗
• 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 21699242 ↗
• 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 21699237 ↗
• 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 21699236 ↗
• 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 21699221 ↗
• InjuryAug 17, 2023Break; Break

  ACCORDING TO THE REPORTER, "ACCORDING TO THE REPORTER, DURING A PERINEAL REPAIR, FOR THE PATIENT HAVING JUST GIVEN BIRTH, WHILE SUTURING, THE NEEDLE BECAME LODGED IN THE PATIENT'S SKIN AS THE THREAD CAME AWAY COMPLETELY. IT WAS EMBEDDED IN THE PERINEAL MUSCLE/TISSUE. THE SUTURE WAS VERY DIFFICULT TO REMOVE AND THIS WAS RECTIFIED BY REMOVING THE NEEDLE WITH SMALL FORCEPS, CAUSING ADDED DISCOMFORT TO THE AND REQUIRED FURTHER TISSUE INJURY TO THE PATIENT. THERE WAS BLOOD LOSS THAT DID NOT EXCEED 500 ML, SURGICAL TIME WAS EXTENDED BY 20 MINUTES, AND INCISION WAS EXTENDED SLIGHTLY. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE."

  Patient problems: Laceration(s)

  MAUDE report 17563898 ↗
• InjuryAug 17, 2023Break; Break

  ACCORDING TO THE REPORTER, "ACCORDING TO THE REPORTER, DURING A PERINEAL REPAIR, FOR THE PATIENT HAVING JUST GIVEN BIRTH, WHILE SUTURING, THE NEEDLE BECAME LODGED IN THE PATIENT'S SKIN AS THE THREAD CAME AWAY COMPLETELY. IT WAS EMBEDDED IN THE PERINEAL MUSCLE/TISSUE. THE SUTURE WAS VERY DIFFICULT TO REMOVE AND THIS WAS RECTIFIED BY REMOVING THE NEEDLE WITH SMALL FORCEPS, CAUSING ADDED DISCOMFORT TO THE AND REQUIRED FURTHER TISSUE INJURY TO THE PATIENT. THERE WAS BLOOD LOSS THAT DID NOT EXCEED 500 ML, SURGICAL TIME WAS EXTENDED BY 20 MINUTES, AND INCISION WAS EXTENDED SLIGHTLY. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE."

  Patient problems: Laceration(s)

  MAUDE report 17563861 ↗
• InjuryAug 17, 2023Break; Break

  ACCORDING TO THE REPORTER, "ACCORDING TO THE REPORTER, DURING A PERINEAL REPAIR, FOR THE PATIENT HAVING JUST GIVEN BIRTH, WHILE SUTURING, THE NEEDLE BECAME LODGED IN THE PATIENT'S SKIN AS THE THREAD CAME AWAY COMPLETELY. IT WAS EMBEDDED IN THE PERINEAL MUSCLE/TISSUE. THE SUTURE WAS VERY DIFFICULT TO REMOVE AND THIS WAS RECTIFIED BY REMOVING THE NEEDLE WITH SMALL FORCEPS, CAUSING ADDED DISCOMFORT TO THE AND REQUIRED FURTHER TISSUE INJURY TO THE PATIENT. THERE WAS BLOOD LOSS THAT DID NOT EXCEED 500 ML, SURGICAL TIME WAS EXTENDED BY 20 MINUTES, AND INCISION WAS EXTENDED SLIGHTLY. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE."

  Patient problems: Laceration(s)

  MAUDE report 17563762 ↗
• MalfunctionJan 27, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE EPISIOTOMY SUTURE LINES WAS BREAKING DOWN AND THERE WAS GAPING OF LINES. IT WAS ALSO REPORTED THAT THE THREAD BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13375703 ↗
• MalfunctionJan 27, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE EPISIOTOMY SUTURE LINES WAS BREAKING DOWN AND THERE WAS GAPING OF LINES. IT WAS ALSO REPORTED THAT THE THREAD BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13375266 ↗
• MalfunctionJul 21, 2021Break; Break

  ACCORDING TO THE REPORTER, "AT THE END OF SUTURING IN A EPISIOTOMY, THE NEEDLE AND THREAD DETACHED. THE NEEDLE WAS FOUND TO CONTINUE THE CASE. THERE WAS NO PATIENT INJURY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12204721 ↗
• MalfunctionJul 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AT THE END OF SUTURING IN A EPISIOTOMY, THE NEEDLE AND THREAD DETACHED. THE NEEDLE WAS FOUND TO CONTINUE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12135152 ↗
• MalfunctionJan 7, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING A PERINEAL SUTURE AFTER A DELIVERY, AT THE END FOR THE CLOSURE, BOTH THE NEEDLE AND THREAD BROKE. THE SURGICAL TIME WAS EXTENDED BY 1 HOUR AND 30 MINUTES TO LOOK FOR THE NEEDLE WITH RADIOGRAPHY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11133195 ↗
• MalfunctionMay 20, 2020Break; Break

  ACCORDING TO THE REPORTER, "BEFORE THE CLOSING OF THE WOUND DURING AN OPEN PROCEDURE, WHEN THE GYNECOLOGIST WANTED TO TAKE THE NEEDLE OUT OF THE PACKAGE, THE SUTURE NEEDLE BROKE. A NEW SUTURE WAS USED TO COMPLETE THE CASE, NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10076571 ↗
• MalfunctionJan 16, 2020Break; Break

  ACCORDING TO THE REPORTER, AT THE END OF EPISIOTOMY CLOSURE WHILE USING A SURJET SUTURING TECHNIQUE, BOTH THE NEEDLE AND SUTURE BROKE. ANOTHER VELOSORB SUTURE USED TO COMPLETE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9596562 ↗
• MalfunctionNov 5, 2018Material Separation; Material Separation

  ACCORDING TO THE REPORTER, "DURING EPISIOTOMY, THE NEEDLE HAS FALLEN OUT OF THE THREAD."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8038495 ↗
• InjuryApr 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AT THE END OF THE PERINEAL SUTURE IN AN OBSTETRICS SURGERY, THE THREAD LOOSENED FROM THE CURVED NEEDLE AND THE NEEDLE BECAME DISLODGED IN THE SUBCUTANEOUS TISSUE OF THE PATIENT'S BUTTOCK. THE PHYSICIAN THEREFORE DEFEATED THE SUTURE AND PERFORMED A RADIOLOGICAL EXAMINATION TO RECOVER THE NEEDLE. AN X-RAY WAS PERFORMED ON THE SAME DATE AS THE SURGERY. THE DOCTOR HAD TO USE A NEW SUTURE AND PUT THE PATIENT UNDER PROPHYLACTIC ANTIBIOTIC THERAPY TO COMPLETE THE CASE. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient; Radiation Exposure, Unintended

  MAUDE report 7398143 ↗
• InjuryNov 10, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, AT THE END OF THE PERINEAL SUTURE IN AN OBSTETRICS SURGERY, THE THREAD LOOSENED FROM THE CURVED NEEDLE AND THE NEEDLE BECAME DISENGAGED IN THE SUBCUTANEOUS TISSUE OF THE PATIENT'S BUTTOCK. THE PHYSICIAN THEREFORE DEFEATED THE SUTURE AND PERFORMED A RADIOLOGICAL EXAMINATION TO RECOVER THE NEEDLE. AN X-RAY WAS PERFORMED ON THE SAME DATE AS THE SURGERY. THE DOCTOR HAD TO USE A NEW SUTURE AND PUT THE PATIENT UNDER PROPHYLACTIC ANTIBIOTIC THERAPY TO COMPLETE THE CASE. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 7019213 ↗

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-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-0046-2021 · 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 o
• 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-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
• 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-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-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-0045-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30" GS-20 CV9975G, UDI: 20884521149585 - Product Usage: indicated for use in soft tissue approximation of the
• 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-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 ap
• 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-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-0029-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-12 Cut, Product Number: SV496, UDI: 20884521184258 - Product Usage: indicated for use in soft tissue
• Z-0011-2021 · Aug 3, 2020 · Terminated
  Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting, Product Number: SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissu

…and 26 more.