Boston Scientific FARASTAR PFA Generator Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Boston Scientific Corporation is recalling 11 units of the FARASTAR PFA Generator due to a labeling discrepancy with the Instructions For Use.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 12, 2026 and geographically references Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Boston Scientific Corporation initiated a voluntary recall because devices were distributed with Instructions For Use (IFU) that did not include FARAPOINT PFA catheter information.
Which Products Are Affected
The recall affects the FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter. A total of 11 units are affected with GTIN 00191506043643 and the following serial numbers: 106205893, 106450787, 107392777, 107476023, 108017345, 108521214, 108577158, 108695934, 109072152, 109484718, 109892816. Distribution occurred internationally in Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, and Ireland. The recall number is Z-2752-2026.
What You Should Do
Consumers with questions should contact the recalling firm, Boston Scientific Corporation, at 4100 Hamline Ave N, Saint Paul, MN 55112-5700.
Why This Matters
This Class II recall addresses a labeling issue that could affect proper use of the cardiac ablation device.
Source
FDA recall number Z-2752-2026, report date 20260729.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,076 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 12, 2026.
Frequently Asked Questions
Common questions about this FDA recall.