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Axium™
SPINAL MODULATION, INC. · Model MN13650 · UDI-DI 05415067025616
PMP
Prescription
0
510(k) clearances
20,102
Adverse events (32 deaths)
2
Recalls
9
Facilities
Description
22cm Big Curve Delivery Sheath Kit
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-05-16 | Abbott Medical | The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling. |
| 2018-03-09 | St. Jude Medical, Inc. | The firm received complaints of error messages that occurred during routine impedance checks on Proclaim DRG IPGs, model 3664. Some complaints were also associated with transient |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.