Medtronic Vascular recalls pediatric Rashkind Balloon Septostomy Catheters (6F, 50 cm) due to field failures and failed quality testing. Affected lot numbers include GFCP2154 through GFDZ1693. 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 have failed quality testing. This could lead to complications for children with cyanotic congenital heart defects.
The catheters may fail during use or have failed quality testing, potentially causing complications for children with cyanotic congenital heart defects. Cyanotic congenital heart defects are rare but serious conditions that require careful treatment.
Children with cyanotic congenital heart defects who use the recalled catheters for atrial septal defect treatment. Parents and caregivers of these children are most at risk.
Check the product lot numbers listed: GFCP2154 through GFDZ1693. The catheters are pediatric, 6F size, 50 cm, with a recess balloon and closed end.
Reach out to Medtronic Vascular for specific instructions on how to handle the recalled product.
The recall is due to subsequent failures of catheters in the field and failed quality testing.
The catheters may fail during use or have failed quality testing, potentially causing complications for children with cyanotic congenital heart defects.
Check the product lot numbers: GFCP2154 through GFDZ1693. The catheters are pediatric, 6F size, 50 cm, with a recess balloon and closed end.
We’ve drafted a message you can send Medtronic Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-0087-2021 — Medtronic Vascular Medtronic Vascular Hello, I own a Medtronic Vascular that is covered by recall Z-0087-2021 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.
