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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Subsequent failure of catheters in the field and failed quality testing"
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…
- 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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