FDA Class II Recall: FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac… by Boston Scientific Corporation — Recall Details

Key facts

What this classification means

A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA still requires the recalling firm to notify affected accounts and submit status reports on the correction, though the monitoring intensity is lower than for a Class I recall. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class II, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.

What consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from Boston Scientific Corporation. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from Boston Scientific Corporation should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to Boston Scientific Corporation directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.

Boston Scientific Corporation’s FDA history

Argus HQ has recorded 285 total FDA actions tied to Boston Scientific Corporation: 0 warning letters, 285 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What is the recall class for Boston Scientific Corporation's recall?

FDA classified this recall as Class II. A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Why was FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutane recalled?

FDA's recall record states the reason as: Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.

Who should I contact about this recall?

Contact Boston Scientific Corporation directly, or the distributor/pharmacy that supplied the product, to confirm whether your specific lot or unit is affected. Argus HQ aggregates the public FDA recall record and is not the recalling firm.

Has Boston Scientific Corporation had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 285 total FDA actions tied to Boston Scientific Corporation, including 285 recalls and 0 warning letters.

Related enforcement actions

• Recall: Boston Scientific Corporation — Class II recall: Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions an… →
• Recall: Boston Scientific Corporation — Class II recall: Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and U… →
• Recall: Boston Scientific Corporation — Class II recall: Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN:… →
• Recall: Boston Scientific Corporation — Class II recall: FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M4… →
• Recall: Boston Scientific Corporation — Class II recall: FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculatu… →
• Recall: Boston Scientific Corporation — Class II recall: FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculatu… →
• Recall: Boston Scientific Corporation — Class II recall: FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vascul… →
• Recall: Boston Scientific Corporation — Class II recall: FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneou… →