INTERGARD Woven Vascular Graft mislabeled with incorrect size specification
Maquet Cardiovascular recalls INTERGARD Woven Vascular Grafts with incorrect labeling. Units labeled as 8 mm diameter instead contained 32 mm diameter grafts.
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: This is a Class II recall of a cardiovascular medical device with a critical labeling error affecting graft diameter. It qualifies as a 'risk-of-harm product where injury has not yet been reported,' warranting High severity.
Plain-English summary
Maquet Cardiovascular, LLC is recalling INTERGARD Woven Vascular Grafts due to a labeling error. Certain units labeled as straight grafts with 8 mm diameter and 30 cm length actually contained straight grafts with 32 mm diameter and 30 cm length.
The affected product is a woven polyester graft coated with bovine collagen, used in cardiovascular surgery. The mislabeled units were distributed nationwide, with noted distribution in South Carolina.
The incorrect labeling could result in a surgeon implanting an unintended graft size during vascular surgery. Patients who received these grafts or those scheduled for surgery with this product should contact their healthcare provider.
Affected lot: 20L12.
The recalled product
- Product
- INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surface and non-velour inner surface. The device is available in straight tubes and bifurcated configurations, as well as hemabridge, aortic arch, thoracic aortic…
- Manufacturer
- Maquet Cardiovascular, LLC
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: (01)00384401000280(11)201112(17)251031(21)1303435656GS(10)20L12
- Lot number: 20L12 Serial number: 1303435656
Distribution
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