Medtronic Rashkind Balloon Septostomy Catheter Recall for Quality Failures
Medtronic Vascular is recalling Rashkind Balloon Septostomy Catheters due to field failures and failed quality testing. The recall covers 2,356 units distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used for a high-risk condition (Cyanotic Congenital heart defect) with reported field failures, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Vascular is recalling the Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen (Product number: 008764). The recall was initiated due to subsequent failure of catheters in the field and failed quality testing. The device is designed for creating an atrial septal defect or enlarging an existing atrial septal defect as a treatment option for patients with a Cyanotic Congenital heart defect.
The recall affects 2,356 units. Distribution was worldwide, including the United States (nationwide) and numerous countries across Europe, Asia, Africa, and the Americas. Specific lot numbers are listed in the source document, including GFCP2154, GFCR2591, and GFDN0246.
Healthcare providers and patients should contact Medtronic Vascular for instructions on how to proceed with the recall. The source text does not report specific injuries or illnesses associated with the failed catheters.
The recalled product
- Product
- Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen Product number: 008764 GTIN: 00613994760289 The Rashkind balloon septostomy catheters are designed for creating an atrial septal defect or enlarging an existing atrial septal
- Manufacturer
- Medtronic Vascular
- Hazard
- Affected units
- 2,356
Distribution
Part of a larger recall action
This product is one of 3 recalled by Medtronic Vascular under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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