Medtronic Recalls CSF-Unitized Shunts Due to Label Discrepancies
Medtronic Neurosurgery is recalling CSF-Unitized Shunts, Delta Shunt Assembly Kits, and Strata II Shunt Assembly Kits due to label discrepancies.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves label discrepancies, which aligns with the rubric for minor labeling errors or low-risk issues.
Plain-English summary
Medtronic Neurosurgery is recalling CSF-Unitized Shunts, Delta Shunt Assembly Kits, and Strata II Shunt Assembly Kits. The recall was initiated because these medical devices were found to have label discrepancies.
The affected products include CSF-Unitized Shunts in Low, Medium, and High Pressure configurations, as well as the Delta and Strata II Shunt Assembly Kits. These devices are designed as integrated CSF-Flow Control Shunts for use in shunting cerebrospinal fluid from the lateral ventricle of the brain into the peritoneal cavity.
The recall involves 288 units total, with 147 units distributed in the United States. The products were distributed nationwide in the US and internationally to Austria, Belgium, Bosnia, Herzegovina, Canada, Croatia, Germany, Japan, Poland, Portugal, Taiwan, the United Arab Emirates, and the United Kingdom. Specific lot numbers for the affected catalog items are listed in the official recall documentation.
The recalled product
- Product
- CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized Shunt, Contoured Regular, Medium Pressure, Catalog No. 46024; CSF-Unitized Shunt, Contoured Regular, High Pressure, Catalog No. 46026. CSF-Unitized Shunt Kits are designed as integrated CSF-
- Manufacturer
- Medtronic Neurosurgery
- Hazard
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 (13)
- Lot Numbers: Catalog No. 46022: D27162
- D30984
- D3461 0
- D35834
- D37761
- D39054
- D39539. Catalog No. 46024: D13944
- D14093
- D14217
- D14216
- D33526
- D39540. Catalog No. 46026: D35572
- D39583.
Distribution
Distributed nationwide across the United States.
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.
See all 3 products in this recall →Related recalls
Same manufacturer · Medtronic Neurosurgery
See all →- HighMedtronic Neurosurgery Recalls Ventriculostomy Kit Due to High Endotoxin Levels
FDA (Devices) · 2026-07-29
- SevereExacta External Drainage System Stopcocks May Leak or Crack
FDA (Devices) · 2024-12-25
- SevereMedtronic Becker Neurosurgical Drainage Systems Recalled for Cracked and Leaking Stopcocks
FDA (Devices) · 2024-12-25
- SevereMedtronic Duet Catheter System Recalled for Potential Disconnection Risk
FDA (Devices) · 2024-03-06
- SevereMedtronic Duet Ventricular Catheter Recalled for Disconnection Risk
FDA (Devices) · 2024-03-06
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02