McKesson SZ497GRecalls & reported problems
Mckesson Medical-Surgical Inc. · SUTURE, PDS CLR MONO 3-0 18" PS-2 (12/BX) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10612479213194), received between Mar 7, 2024 and Oct 16, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 reports).
1 other recall cover devices cleared under the same FDA submission (K990951); 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component6
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE NEEDLE OF THE TWO SUTURES WERE NOT ATTACHED TO THE THREAD.
Patient problems: Insufficient Information
MAUDE report 23308379 ↗MalfunctionOct 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE NEEDLE OF THE TWO SUTURES WERE NOT ATTACHED TO THE THREAD.
Patient problems: Insufficient Information
MAUDE report 23308020 ↗MalfunctionMar 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A MINOR SKIN CANCER SURGERY ON THE TRUNK, THE NEEDLE DETACHED FROM THE SUTURE. THE PROVIDER NOTED THAT WHEN THE FIRST STITCH WAS THROWN WITH VERY LITTLE TENSION, THE NEEDLE SEPARATED FROM THE SUTURE. THIS INCIDENT OCCURRED IN A STERILE ENVIRONMENT AND WAS REPORTED TO HAVE HAPPENED ON TWO SEPARATE OCCASIONS IN DIFFERENT OFFICES, INDICATING THE USE OF DIFFERENT BOXES. NO HARM OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21504489 ↗MalfunctionMar 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A MINOR SKIN CANCER SURGERY ON THE TRUNK, THE NEEDLE DETACHED FROM THE SUTURE. THE PROVIDER NOTED THAT WHEN THE FIRST STITCH WAS THROWN WITH VERY LITTLE TENSION, THE NEEDLE SEPARATED FROM THE SUTURE. NO HARM OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21504302 ↗MalfunctionApr 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A MINI ABDOMINOPLASTY PROCEDURE, 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 19102625 ↗MalfunctionMar 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
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: No Clinical Signs, Symptoms or Conditions
MAUDE report 18862983 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K990951. One submission often covers many models, so check the product and lot details in each record.
- Z-2542-2017 · May 3, 2017 · TerminatedSutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933; MAXON 5/0 5X18 GR CV-23 D-TACH; Item Number: XX2109; MAXON* 4/0 5X30 GREEN V-20 D*TACH; Item Number:
Other Suture, Absorbable, Synthetic, Polyglycolic Acid devices
- Coated VICRYL VCP433HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death1,093 reports
- Polysorb CL-915Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID503 reports
- Coated VICRYL VCP493HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID435 reports
- V-Loc 180 VLOCL0316Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall376 reports
- Coated VICRYL VCP345HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death405 reports
- V-Loc 180 VLOCL0604Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall328 reports
- V-Loc 180 VLOCA008LCovidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall294 reports
- V-Loc 180 VLOCL0326Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID330 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page