Medtronic Vascular Recalls Rashkind Balloon Septostomy Catheters Due to Field Failures
Medtronic Vascular is recalling 505 units of Rashkind Balloon Septostomy Catheters due to subsequent field failures and failed quality testing.
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 high-risk medical device used for treating rare congenital heart defects, and the source explicitly cites 'subsequent failure of catheters in the field,' which constitutes a risk-of-harm product where injury has not yet been reported in the text.
Plain-English summary
Medtronic Vascular is recalling 505 units of the Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Single Lumen (Product number: 007161). The recall was initiated due to subsequent failure of catheters in the field and failed quality testing.
The affected catheters are 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 covers specific lot numbers including GFCR2342, GFCR2583, GFCX2785, GFCY3003, GFDN0248, GFDQ2501, GFDR2902, GFDS2211, GFDT2171, GFDT2201, GFDU2169, GFDV2178, GFDW2400, GFDX2710, GFDY1133, and GFDY1134.
The products were distributed worldwide, including nationwide in the United States and in numerous international countries. Healthcare providers and patients should contact Medtronic Vascular for further instructions regarding the recall and replacement of affected devices.
The recalled product
- Product
- Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007161 GTIN: 00613994760272 The Rashkind balloon septostomy catheters are designed for creating an atrial septal defect or enlarging an existing atrial septal defect as a tre
- Manufacturer
- Medtronic Vascular
- Hazard
- Affected units
- 505
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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