Vascu-Guard Peripheral Vascular Patch marketing materials contain inaccurate information
Baxter Healthcare is recalling marketing materials for its Vascu-Guard Peripheral Vascular Patch because a cardiovascular surgery brochure contains inaccurate content conflicting with official Instructions for Use and Prescribing Information.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device classified as a risk-of-harm product (cardiovascular surgical device). Inaccurate marketing materials conflicting with official Instructions for Use could lead to improper use among healthcare providers. No illnesses or injuries have been reported, keeping this at the maximum threshold for unharmed risk-of-harm products per the rubric.
Plain-English summary
Baxter Healthcare Corporation is recalling marketing materials for the Vascu-Guard Peripheral Vascular Patch, an FDA Class II medical device used in cardiovascular surgery. The recall involves a cardiovascular surgery marketing brochure (US-AS46-220001) that contains inaccurate content not aligned with the product's Instructions for Use and Prescribing Information. The affected product is distributed nationwide in the United States.
The marketing brochure's inaccurate content could cause confusion regarding proper use of the device among healthcare providers. The discrepancy between marketing materials and official product documentation highlights the importance of referring to the Instructions for Use and Prescribing Information for accurate guidance.
Healthcare facilities and providers should disregard the inaccurate marketing brochure and use only the official Instructions for Use and Prescribing Information when preparing to use or implanting the Vascu-Guard Peripheral Vascular Patch. Baxter Healthcare initiated this recall to ensure consistency between all marketing materials and official product documentation.
Affected product codes include VG0108N (0.8X8 CM), VG0110N (1X10 CM), VG0106N (1X6 CM), and VG0209N (2X9 CM), with all serial numbers included in the recall.
The recalled product
- Product
- Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: 0.8X8 CM GLOBAL, b) VG0110N: 1X10 CM GLOBAL, c) VG0106N: 1X6 CM GLOBAL, d) VG0209N: 2X9 CM GLOBAL
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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