LivaNova recalls Inspire 6 Integrated Phisio OXY with HVR Reservoir due to incorrect expiration date in UDI barcode. The expiration date is printed as DDMMYY instead of YYMMDD, but package labels show correct dates.
Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique Device Identification (UDI) bar code and readable code just beneath the barcode. Specifically, the expiration date is reported as DDMMYY instead of YYMMDD. The expiration date in the applicable field on the package labels are correct as printed.
LivaNova is recalling Inspire 6 Integrated Phis:io OXY with HVR Reservoir devices because some have an incorrect expiration date in the UDI barcode. This could lead to confusion about when the product expires, but the package labels show the correct expiration date. The recall does not pose an immediate safety risk to users.
The expiration date in the UDI barcode is printed incorrectly as DDMMYY instead of the standard YYMMDD format. This could cause confusion about the product's expiration date, but the package labels show the correct expiration date.
Patients using Inspire 6 devices for cardiopulmonary bypass surgery are likely affected. Those with the specific catalog number 050713 and lot number 1709190228 are most at risk.
Check for the catalog number 050713 on the Inspire 6 Integrated Phisio OXY with HVR Reservoir. The lot number 1709190228 and UDI (01)08033178112352(17)200917(10)1709190228 are also specific identifiers for this recall.
Look for the catalog number 050713 and lot number 1709190228 on the Inspire 6 device packaging.
No, the recall is low risk. The expiration date in the UDI barcode is printed incorrectly, but the package labels show the correct expiration date.
Check the product labels for the catalog number 050713 and lot number 1709190228. If you have these identifiers, contact LivaNova for further instructions.
LivaNova recalled the Inspire 6 devices because some have an incorrect expiration date format in the UDI barcode, which could cause confusion about the product's expiration date.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-1918-2018 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-1918-2018 from LivaNova. 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.
