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Sunday, 7 June 2026 · Vol. 1 · No. 5
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Sunday, 7 June 2026 edition — The Vital Record
Vol. 1 · No. 5Sunday, 7 June 2026“Evidence over expectation. Surrogates flagged, survival pending.”
Implants under the recallSum of two openFDA enforcement records initiated 2026-03-19, posted 2026-04-24: 718,456 non-CRT pacemakers + 685,776 CRT-Ps. Correction is an in-office software update (SMR6), not a device removal. Adverse events: 4 deaths (HRS clinician notice) and 2,557 serious injuries as of March 18, 2026 (FDA correction notice as reported by trade media; not reconfirmed on a reachable FDA primary page).
The agency's most serious recall class applies to an in-office software update, not a device removal — and no working pacemaker need be explanted, with the FDA stating prophylactic replacement is not recommended before high battery impedance is confirmed.
The FDA has designated Boston Scientific’s software correction for its Accolade family of pacemakers a Class I recall — the agency’s most serious category, reserved for situations in which use of a device can cause serious injury or death. The action covers two paired records initiated March 19, 2026, that together reach 1,404,232 implanted devices worldwide.
This is a software correction, not a device removal. No one is being asked to explant a working pacemaker. Boston Scientific is distributing a software update, Brady Software Maintenance Release 6 (SMR6), to be applied during routine in-office device-check appointments across the Accolade, Proponent, Essentio, Altrua 2, Visionist, and Valitude lines.
In NeoADAURA, osimertinib before surgery met its primary pathology endpoint (MPR) in resectable EGFR-mutant NSCLC, but the interim survival comparison was not statistically significant — and neoadjuvant use remains investigational.
FDA & RegulatoryFDA approves AbbVie's DECNUPAZ for ultra-rare blood cancer BPDCN, on a single-arm response endpointPivekimab sunirine-pvzy clears priority review on a single-arm trial: the headline 69.7% complete-response rate is the best-case newly diagnosed subgroup, relapsed/refractory disease responded far less (15.7%), no survival benefit has been shown, and the label carries a boxed warning for fatal hepatotoxicity.