Datascope Corporation recalls specific Maquet Reinforced Introducer Sets (part number 0684 00 0403 06) due to potential sterility compromise in breached pouches of certain lots. Affected units may pose infection risks if used improperly.
Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.
Datascope Corporation is recalling specific Maquet Reinforced Introducer Sets (part number 0684 00 0403 06) because pouches in certain lots could breach, risking infection if the device is used. This is a medical device accessory for percutaneous insertion of intra-aortic balloon catheters.
The pouches in specific lots (lot codes 3000051658, TLT) may breach, potentially compromising sterility. If the device is used without the pouch being intact, infection risks could increase.
Healthcare professionals using these medical devices for procedures involving intra-aortic balloon catheters. Patients receiving such procedures are at risk if the device is compromised.
Check for part number 0684 00 0403 06 on the device. Look for lot codes 3000051658 or TLT on the packaging or device label.
Inspect the pouch for signs of breach or damage before use. If breached, do not use the device.
The part number is 0684 00 0403 06.
Lot codes 3000051658 and TLT are affected.
The recall record does not specify a remedy.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-0932-2020 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-0932-2020 from Maquet. 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.
