CLASS II ONGOING Device recall · Reported 17 Jan 2024 · FDA Enforcement Report
Vascu-Guard Peripheral Vascular Patch (US), Product Codes recalled
Baxter Healthcare is recalling Vascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: CM US, TS, distributed nationwide in the US. The recall was initiated on 6 Dec 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0666-2024
- FDA event ID
- 93503
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Dec 2023
- FDA classified
- 5 Jan 2024
- Reported
- 17 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Heart & Vascular Devices
Timeline
| 6 Dec 2023 | Recall initiated by company | |
| 5 Jan 2024 | Classified by FDA | +30 days |
| 17 Jan 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
Product as listed by the FDA
Vascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: 0.8 X 8 CM US, TS; b) VG0110: 1 X 10 CM US, TS; c) VG0106: 1 X 6 CM US, TS; d) VG0209: 2 X 9 CM US, TS
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Vascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: CM US, TS recalled?
Yes. Baxter Healthcare recalled Vascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: CM US, TS on 6 Dec 2023. The recall is Class II and its status is Ongoing. Recall number Z-0666-2024.
Why was it recalled?
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
Which lots are affected?
a) VG0108: UDI/DI 0338-9564-06, b) VG0110: UDI/DI 0338-9564-07, c) VG0106: UDI/DI 0338-9564-08, d) VG0209: UDI/DI 0338-9564-09, All serial numbers
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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