Bard Lifestream Vascular Stent Recall Due to Sheath Compatibility Issues
Bard Peripheral Vascular is recalling 127 Lifestream stents in Australia due to potential difficulty advancing the catheter through a 6F introducer sheath.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a procedural difficulty that may prolong a procedure, with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Bard Peripheral Vascular Inc is recalling 127 units of the Lifestream Balloon Expandable Vascular Covered Stent. The affected units were distributed in Australia to 32 consignees. The recall involves specific product codes (LSM0800626, LSM1350626, LSM0800637, LSM1350637, LSM0800726, LSM1350726) with lot numbers beginning with CMA or CMB.
The recall is issued because certain product code and lot number combinations may experience introducer sheath compatibility issues when used with a 6F introducer sheath. Using the affected stents with this specific sheath could result in difficulty or the inability to insert or advance the catheter through the sheath. This issue could potentially lead to a slight prolongation of the medical procedure.
The Lifestream stent is indicated for the treatment of atherosclerotic lesions in common and external iliac arteries. The source text does not report any illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- LIFESTREAM Balloon Expandable Vascular Covered Stent . BARD PERIPHERAL VASCULAR. 6mm X 26mm X 80 Recommended Introducer 6F (2.00mm) NP 8atm (811 kPa) Recommended Guide wire .035" (0.89mm) RBP 12 atm (1216 kPa) RX Only Lot numbers begins with CMA or CMB. Product Code…
- Manufacturer
- Bard Peripheral Vascular Inc
- Category
- Medical Device — Vascular Stent
- Affected units
- 127
Distribution
Distribution scope not specified by the agency.
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