Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Reinforced Introducer Sets Maquet 8 Fr. Recalled by Datascope Corporation Due to Potential for compromised sterility in breached pouches of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Datascope Corporation directly.
Affected Products
Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic Balloon Catheters.
Quantity: 523
Why Was This Recalled?
Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.
Where Was This Sold?
This product was distributed to 36 states: AL, AK, AZ, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MI, MN, MS, MO, NE, NJ, NY, NC, ND, OH, OK, PA, SC, SD, TN, TX, VA, WA, WV, WI
About Datascope Corporation
Datascope Corporation has 67 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report