Home › MEDTRONIC NAVIGATION, INC. › Polestar

Polestar

MEDTRONIC NAVIGATION, INC. · Model 9733487 · UDI-DI 00613994316264

LNH Prescription

510(k) clearances

4,751

Adverse events (37 deaths)

699

Recalls

145

Facilities

Description

SET 9733487 INTEGRATED SKULL PINS

Recalls

Date	Firm	Reason
2026-04-14	Philips North America	The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction
2026-04-14	Philips North America	The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction
2026-04-14	Philips North America	The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction
2026-04-14	Philips North America	The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction
2026-04-14	Philips North America	The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction
2026-04-14	Philips North America	The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction
2026-04-14	Philips North America	The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction
2026-04-14	Philips North America	The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction
2026-04-14	Philips North America	The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction
2026-04-14	Philips North America	The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data 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.