McKesson SY493GXRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10612479214245), received between Nov 6, 2019 and Mar 7, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

28 other recalls cover devices cleared under the same FDA submission (K000037); 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2024Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A SCAR REVISION, THE SURGEON NOTED THAT THE SUTURE WAS PULLING OFF THE NEEDLE. ANOTHER SUTURE FROM ANOTHER BOX WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18862973 ↗
• MalfunctionJan 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE BROKE OFF THE SUTURE.

  Patient problems: Insufficient Information

  MAUDE report 18544348 ↗
• MalfunctionOct 24, 2022Component Missing; Component Missing

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THREE SUTURES WERE OPENED FROM THE SAME BOX, HOWEVER THERE WERE NO NEEDLES ATTACHED TO THE SUTURES OPENED. CUSTOMER RETRIEVED A DIFFERENT BOX OF SAME SUTURE FOR CASE TO RESOLVED THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15661012 ↗
• MalfunctionMay 12, 2022Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, EVERY SINGLE SUTURE THAT HAS BEEN USED IN SURGERY FOR A PATIENT IN THIS ORDER HAVE BEEN UNRAVELLING AT ANY LENGTH CUT. MULTIPLE 5-0 SUTURES MUST BE DROPPED DUE TO UNRAVELLING.

  Patient problems: Insufficient Information

  MAUDE report 14367241 ↗
• MalfunctionMay 12, 2022Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, EVERY SINGLE SUTURE THAT HAS BEEN USED IN SURGERY FOR A PATIENT IN THIS ORDER HAVE BEEN UNRAVELLING AT ANY LENGTH CUT. MULTIPLE 5-0 SUTURES MUST BE DROPPED DUE TO UNRAVELLING.

  Patient problems: Insufficient Information

  MAUDE report 14367231 ↗
• MalfunctionDec 13, 2019Break; Break

  ACCORDING TO THE REPORTER, THE SUTURES BROKE DURING USE.

  Patient problems: No Information

  MAUDE report 9466186 ↗
• MalfunctionNov 15, 2019Break; Break

  ACCORDING TO THE REPORTER, FOUR SUTURES WERE BROKEN.

  Patient problems: No Information

  MAUDE report 9329251 ↗
• MalfunctionNov 15, 2019Break; Break

  ACCORDING TO THE REPORTER, FOUR SUTURES WERE BROKEN.

  Patient problems: No Information

  MAUDE report 9329096 ↗
• MalfunctionNov 15, 2019Break; Break

  ACCORDING TO THE REPORTER, FOUR SUTURES WERE BROKEN.

  Patient problems: No Information

  MAUDE report 9329053 ↗
• MalfunctionNov 6, 2019Break; Break

  ACCORDING TO THE REPORTER, THE SUTURE BROKE.

  Patient problems: No Information

  MAUDE report 9286289 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000037. One submission often covers many models, so check the product and lot details in each record.

• Z-1298-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 0 30" VIOLET GU-46, Item Code UL877 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not i
• Z-1288-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2/0 UNDYED 30" V-30 (75CM), Item Code GL228 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, b
• Z-1293-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10, Item Code SL1625G - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but no
• Z-1274-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 (75CM), Item Code CL461 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery,
• Z-1297-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23, Item Code UL203 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1277-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 3/0 30 VIOLET GS-11, Item Code CL815 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1296-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K, Item Code SL654 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1292-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 6-0 18" UNDYED SS-24 D/A, Item Code L2752K - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, bu
• Z-1290-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 3/0 30" UNDYED V-20, Item Code GLS322 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1280-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24, Item Code CL911 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not i
• Z-1295-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture UD 4/0 18 P-13, Item Code SL5690 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in c
• Z-1289-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20, Item Code GL323 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1285-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21, Item Code CL953 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1276-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21, Item Code CL811 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1279-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but no

…and 13 more.