Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0620-2016·Announced 2016-01-20

Boston Scientific MRI PROPONENT SR Pacemaker Recall for Incorrect Literature Labeling

Boston Scientific is recalling five MRI PROPONENT SR pacemakers because the included literature incorrectly describes the device's pacing mode.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to incorrect documentation (literature packet) describing the pacing mode, which aligns with the rubric for minor labeling errors or voluntary precautionary recalls without reported injury.

Plain-English summary

Boston Scientific Corporation is recalling five units of the MRI PROPONENT SR pacemaker, reference L210. These devices are used to treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy. The affected units have serial numbers 702961, 702963, 705644, 705666, and 705947.

The recall was initiated because the literature packet packaged with the devices incorrectly describes the pacemaker's pacing mode. Specifically, the literature may describe the pacemaker as SR when it is actually a DR pacemaker, or as DR when it is actually an SR pacemaker. This is a documentation error regarding the device's specifications.

The affected devices were distributed internationally to Colombia, Jamaica, and Trinidad & Tobago. The source text does not specify actions for consumers or patients, as the recall pertains to the accuracy of the accompanying documentation rather than a functional defect in the implanted device.

The recalled product

Product: Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Pacemaker
Hazard: mis-labeling
Affected units: 5

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

Serial numbers 702961
702963
705644
705666
and 705947.

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Boston Scientific Corporation

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Same hazard · mis labeling