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Plexa ProMRI

BIOTRONIK SE & Co. KG · Model DF-1 SD 65/18 · UDI-DI 04035479151003

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510(k) clearances

138,567

Adverse events (3,088 deaths)

Recalls

Facilities

Recalls

Date	Firm	Reason
2025-07-24	Boston Scientific Corporation	Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacem
2025-07-24	Boston Scientific Corporation	Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacem
2022-09-30	Boston Scientific Corporation	There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
2022-09-30	Boston Scientific Corporation	There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
2021-11-08	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)	The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR condition

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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.