PIVO 20G 202-0005Recalls & reported problems
Velano Vascular, Inc. · PIVO (2.0) 20G compatible device. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850984007027), received between Jan 11, 2024 and Jan 11, 2024 — classified as 1 injury.
1 FDA recall record name this device's identifier.
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.
Reports received per month
Recalls naming this device
- Nov 10, 2021Class IITerminated
Incomplete sealing of blood collection device unit packages may produce a breach in the sterile barrier enclosing the product. This could lead to microbial contamination of the device prior to use. The health effects range from no clinical effect up to bloodstream infection.
Z-0527-2022 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT BD PIVO BLOOD COLLECTION HAD PATIENT WHO WAS DIAGNOSED WITH AN INFECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPRESENTATIVES OF (B)(6) NETWORK HAVE MADE VERBAL COMMENTS WITH CONCERNS OF INCREASED INFECTIONS IN PATIENTS: MATERIAL 2: 202-0005 LOT: 092322-02
Patient problems: Insufficient Information
MAUDE report 18499893 ↗
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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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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