Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Numbers: 0010052549, 0010289829, 0010305920, 0010353501, 0010384893, 0010052552, 0010289830, 0010305921, 0010353502, 0010384894, 0010149011, 0010289831, 0010305923, 0010353503, 0010384895, 0010149013, 0010289833, 0010305926, 0010353504, 0010384896, 0010258434, 0010289834, 0010316955,, 0010369362, 0010393213, 0010265136, 0010297686, 0010316956, 0010369364, 0010393215, 0010265137, 0010297689, 0010316957, 0010369365, 0010393216, 0010265138, 0010297691, 0010316958, 0010376787, 0010393814, 0010278408, 0010297693, 0010336617, 0010376788, 0010393839, 0010278409, 0010297696, 0010336618, 0010376789, 0010289827, 0010305912, 0010336619, 0010376790, 0010289828, 0010305919, 0010353500, 0010384892
- 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 Neurosurgery
- Reason for Recall:
- There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, requiring further medical intervention.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
Product Codes/Lot Numbers:
Lot Numbers: 0010052549, 0010289829, 0010305920, 0010353501, 0010384893, 0010052552, 0010289830, 0010305921, 0010353502, 0010384894, 0010149011, 0010289831, 0010305923, 0010353503, 0010384895, 0010149013, 0010289833, 0010305926, 0010353504, 0010384896, 0010258434, 0010289834, 0010316955,, 0010369362, 0010393213, 0010265136, 0010297686, 0010316956, 0010369364, 0010393215, 0010265137, 0010297689, 0010316957, 0010369365, 0010393216, 0010265138, 0010297691, 0010316958, 0010376787, 0010393814, 0010278408, 0010297693, 0010336617, 0010376788, 0010393839, 0010278409, 0010297696, 0010336618, 0010376789, 0010289827, 0010305912, 0010336619, 0010376790, 0010289828, 0010305919, 0010353500, 0010384892
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0738-2021
Related Recalls
Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
Potential for catheter disconnection from the patient line stopcock connectors.