Boston Scientific FARASTAR Pulsed Field Ablation 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 one FARASTAR Pulsed Field Ablation 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, medical-devices.
What Happened
Boston Scientific Corporation is conducting a voluntary recall of the FARASTAR Pulsed Field Ablation Generator 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 Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter. One unit is affected with GTIN 00191506042547 and serial number 106247020. Distribution occurred internationally in Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, and Ireland. The recall number is Z-2751-2026.
What You Should Do
Consumers should contact Boston Scientific Corporation for further information regarding the recall.
Why This Matters
The labeling discrepancy affects the proper use instructions for the device in international markets.
Source
FDA recall Z-2751-2026: https://www.fda.gov
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 (957 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.