Medtronic Ares Antibiotic-Impregnated Catheter Recall for Seal Defect
Medtronic is recalling Ares Antibiotic-Impregnated Catheters due to a potential seal defect that may compromise sterility and increase the risk of post-operative infection.
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 risk-of-harm product (potential post-operative infection) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Medtronic Neurosurgery is recalling the Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101. This sterile, prescription-only device is used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
The recall is due to a potential defect on the seal of the outer pouch of the catheters. This defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, requiring further medical intervention.
The affected units were distributed worldwide, including nationwide in the United States and in numerous other countries. The recall covers 3,165 units across specific lot numbers. Healthcare providers and patients should contact Medtronic Neurosurgery for further instructions on how to proceed with the recall.
The recalled product
- Product
- 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.
- Manufacturer
- Medtronic Neurosurgery
- Category
- Medical Device — Neurosurgery
- Affected units
- 3,165
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot Numbers: 0010052549
- 0010289829
- 0010305920
- 0010353501
- 0010384893
- 0010052552
- 0010289830
- 0010305921
- 0010353502
- 0010384894
- 0010149011
- 0010289831
- 0010305923
- 0010353503
- 0010384895
- 0010149013
- 0010289833
- 0010305926
- 0010353504
- 0010384896
Distribution
Part of a larger recall action
This product is one of 3 recalled by Medtronic Neurosurgery 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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