McKesson 200-IVS201Recalls & reported problems
Mckesson Medical-Surgical Inc. · Sliding Safety IV Catheter STRAIGH HUB 20G x 1 in (1.1 mm x 25.4 mm) · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10612479267487), received between Jun 9, 2025 and Oct 27, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Fail-Safe Problem1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 27, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT BLOOD LEAKED DUE TO SAFETY COVER NOT SLIDING OVER NEEDLE. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23389882 ↗MalfunctionJun 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER THAT ONCE THE CATHETER WAS INSERTED, THE CATHETER WAS SEPARATED FROM THE BARREL. THE CATHETER WAS ABLE TO BE REMOVED FROM THE PATIENT. THE CATHETER WAS BARELY OUT OF THE SKIN AND STILL IN THE VEIN. SHE WAS ABLE TO REMOVE IT. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22195341 ↗InjuryJun 9, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
THE CATHETER WAS SEPARATED FROM THE BARREL POINT. THE CATHETER WAS BARELY OUT OF THE SKIN AND STILL IN THE VEIN.
Patient problems: Foreign Body In Patient
MAUDE report 22169928 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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