Bard Peripheral Vascular recalls LIFESTREAM balloon expandable vascular stents with specific lot numbers due to potential issues when used with 6F introducer sheaths, which may cause insertion difficulties.
Certain product code/lot number combinations may experience introducer sheath compatibility issues when used with a 6F introducer sheath. Using the affected balloon expandable vascular covered stents with a 6F introducer sheath could result in difficulty or the inability to insert or advance the catheter through the introducer sheath. This could potentially lead to a slight prolongation of the procedure.
Bard Peripheral Vascular is recalling specific LIFESTREAM balloon expandable vascular stents that may not work properly with 6F introducer sheaths. This could cause insertion problems during medical procedures, potentially prolonging the procedure.
The recalled stents may not fit correctly with 6F introducer sheaths, making it harder to insert or advance the catheter. This could lead to a longer procedure time but does not cause immediate injury or death.
Healthcare professionals using the recalled stents with 6F introducer sheaths are most at risk. Patients receiving these stents during procedures may experience longer treatment times.
Check the product code on the stent packaging. Recalled items have product codes starting with LSM0800 or LSM1350 and lot numbers beginning with CMA or CMB.
Look for product codes starting with LSM0800 or LSM1350 on the stent packaging.
Ensure the lot number begins with CMA or CMB to confirm the recalled item.
Stents with product codes LSM0800626, LSM1350626, LSM0800637, LSM1350637, LSM0800726, or LSM1350726 and lot numbers starting with CMA or CMB.
The stents may not work properly with 6F introducer sheaths, causing insertion difficulties during procedures.
No, but healthcare professionals should check if they have the recalled stents before using them with 6F introducer sheaths.
We’ve drafted a message you can send Bard Peripheral Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-0718-2020 — Bard Peripheral Vascular Bard Peripheral Vascular Hello, I own a Bard Peripheral Vascular that is covered by recall Z-0718-2020 from Bard Peripheral Vascular. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
