Boston Scientific Corporation: The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR pacemaker.

Agency Publication Date: January 8, 2016

Affected Products

Product: Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary

Serial numbers 702961, 702963, 705644, 705666, and 705947.

Product: Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.

Serial numbers 209409, 209518, and 209609.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 72855

Status: Resolved

Manufacturer: Boston Scientific Corporation

Manufactured In: United States

Units Affected: 2 products (5; 3)

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Sources: FDA iRES · Raw API Response

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Medium RiskFDA Device