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 treatment option for patients with a Cyanotic Congenital heart defect. Cyanotic congenital heart defects are rare conditions that are associated with high morbidity and mortality.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Numbers : GFCR2342 GFCR2583 GFCX2785 GFCY3003 GFDN0248 GFDQ2501 GFDR2902 GFDS2211 GFDT2171 GFDT2201 GFDU2169 GFDV2178 GFDW2400 GFDX2710 GFDY1133 GFDY1134
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medtronic Vascular
- Reason for Recall:
- Subsequent failure of catheters in the field and failed quality testing
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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 treatment option for patients with a Cyanotic Congenital heart defect. Cyanotic congenital heart defects are rare conditions that are associated with high morbidity and mortality.
Product Codes/Lot Numbers:
Lot Numbers : GFCR2342 GFCR2583 GFCX2785 GFCY3003 GFDN0248 GFDQ2501 GFDR2902 GFDS2211 GFDT2171 GFDT2201 GFDU2169 GFDV2178 GFDW2400 GFDX2710 GFDY1133 GFDY1134
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0089-2021
Related Recalls
Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only
Medtronic Vascular
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention to attempt to remove the taper tip, either by endovascular retrieval or surgical conversion. There is also potential that the taper tip is intentionally left behind in the patient, at the physician's discretion, if not easily removable.