Medtronic Vascular recalls pediatric Rashkind Balloon Septostomy Catheters (5F, 50 cm) due to field failures and failed quality testing. Affected lot numbers include GFCT1699 through GFZ2173. Consumers should contact Medtronic for details.
Subsequent failure of catheters in the field and failed quality testing
Medtronic Vascular is recalling pediatric Rashkind Balloon Septostomy Catheters that may fail in the field or fail quality testing. This could lead to complications for children with cyanotic congenital heart defects.
The catheters may fail during use or fail quality testing, potentially causing complications for children with cyanotic congenital heart defects. These defects are rare but serious conditions requiring precise medical interventions.
Parents or caregivers of children with cyanotic congenital heart defects who use these catheters for treatment. Children with specific heart conditions are most at risk.
Check the product number (007160) and lot numbers listed: GFCT1699 through GFZ2173. These catheters are designed for pediatric use in specific heart conditions.
Reach out to Medtronic Vascular for specific instructions on how to handle the recalled catheters.
The product number is 007160.
Lot numbers include GFCT1699, GFCT2030, GFCW2430, and others up to GFZ2173.
The recall is due to field failures and failed quality testing of the catheters.
We’ve drafted a message you can send Medtronic Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-0088-2021 — Medtronic Vascular Medtronic Vascular Hello, I own a Medtronic Vascular that is covered by recall Z-0088-2021 from Medtronic 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.
