Boston Scientific CRT Devices Recall
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Boston Scientific Corporation is voluntarily recalling certain Cardiac Resynchronization Therapy pacemakers due to an updated software maintenance release, affecting 685,776 units worldwide.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 13, 2026 and geographically references worldwide. Its severity classification of "high" 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, cpsc, Devices.
What Happened
Boston Scientific Corporation is issuing a recall for an updated software, Brady software maintenance release 6 (SMR6), which is now available for the ACCOLADE family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps). The advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices, specifically for treatment of conduction disorders, VVI intolerance, and low cardiac output secondary to bradycardia.
Which Products Are Affected
The affected products are Boston Scientific Cardiac Resynchronization Therapy (CRT) devices, including: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL MRI, Model Number U128; 3. VISIONIST CRT-P EL, Model Number U225; 4. VISIONIST CRT-P EL, Model Number U226; 5. VISIONIST CRT-P EL MRI, Model Number U228. A total of 685,776 units are involved. The advisory includes all serialized DR-EL pacemakers and CRT-Ps from the ACCOLADE family, as well as ACCOLADE DR-SL and SR-SLs with a use-by-date on or before 30 June 2025. Distribution is worldwide, and to determine if a device is affected, use the device lookup tool at www.BostonScientific.com/lookup. The official recall number is Z-1771-2026.
What You Should Do
Consumers should check if their device is affected by entering the model and serial number into the device lookup tool at www.BostonScientific.com/lookup. For further information, contact Boston Scientific Corporation, as this is a voluntary firm-initiated recall notified via letter.
Why This Matters
This recall involves medical devices critical for treating heart conditions, potentially affecting patient safety due to the need for updated software in pacemakers and CRT-Ps.
Source
FDA Recall Number Z-1771-2026
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 (1,767 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to May 13, 2026.
Frequently Asked Questions
Common questions about this FDA recall.