Medtronic Preimplantation Test Kit Recalled for Incorrect Expiration Dates
Medtronic Neurosurgery is recalling Preimplantation Test Kits because the outer carton expiration dates are later than the dates on the individual sterile components.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is a documentation and packaging labeling issue where the outer carton date is later than the component dates, fitting the rubric for cosmetic defects or documentation issues.
Plain-English summary
Medtronic Neurosurgery is recalling the Medtronic Preimplantation Test Kit, Catalog No. 21047. The recall involves 915 units that were distributed nationwide in the United States. The kit is indicated for use with Medtronic CSF-Flow Control Valves and Delta Valves to verify that the valve conforms to labeled product specifications.
The recall was initiated because the expiration dates printed on the outer carton are incorrect. Specifically, the date on the outer carton is later than the expiration date for one or more of the individually packaged sterile components contained within the kit.
Healthcare providers and facilities that have received these kits should stop using them and contact Medtronic Neurosurgery for instructions on how to return or dispose of the affected units.
The recalled product
- Product
- Medtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated for use with Medtronic CSF-Flow Control Valves and Delta Valves, when a simple preimplantation test is desired to verify that the valve conforms to labeled product specifications.
- Manufacturer
- Medtronic Neurosurgery
- Category
- Medical Device — Neurosurgery
- Hazard
- Affected units
- 915
Distribution
Distributed nationwide across the United States.
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 →- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- HighByron White A-L Complex Herbal Supplement Recalled for Undeclared Walnut
FDA (Food) · 2026-09-02
- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02