Gore recalls pediatric vascular grafts that may be incorrectly labeled as 5mm or 6mm. This could lead to improper medical use if the wrong size is used during surgery.
Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectly labeled as 6 mm.
Gore is recalling pediatric vascular grafts that may be mislabeled as 5mm when they are actually 6mm or vice versa. Using the wrong size could cause improper medical procedures during surgery.
The grafts may be incorrectly labeled as 5mm when they are actually 6mm or vice versa. This could lead to using the wrong size during surgery, potentially causing complications for pediatric patients.
Pediatric patients requiring vascular shunts who have been prescribed these specific Gore grafts. Medical professionals using the recalled grafts are most at risk.
Check for the reference numbers HPT050010 or HPT050010A with specific serial numbers listed in the recall notice. These grafts are for pediatric shunts only and require a prescription.
Look for the reference numbers HPT050010 or HPT050010A with the specific serial numbers listed in the recall notice.
The vascular grafts may be incorrectly labeled as 5mm when they are actually 6mm or vice versa, which could lead to improper medical use during surgery.
Check the product label for the reference numbers and serial numbers listed in the recall notice to determine if your grafts are affected.
The recall indicates a potential mislabeling risk, but the grafts are generally safe if used correctly with the proper size.
We’ve drafted a message you can send Gore to request your refund or repair — edit it as you like.
Subject: Recall Z-2292-2021 — Gore Gore Hello, I own a Gore that is covered by recall Z-2292-2021 from Gore. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
