Key facts
| Recalling firm | Boston Scientific Corporation |
|---|---|
| Manufacturer | Not disclosed in the FDA record. |
| Brand name | Not disclosed in the FDA record. |
| Product description | Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 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. |
| Classification | Class I |
| Recall number | Z-1771-2026 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| Reason for recall | Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia |
What consumers should do
Because FDA has assigned this recall its highest severity classification, anyone who has this product should stop using it immediately, regardless of whether a problem has been noticed yet. Specifically, check whether the product in your possession matches the description on file with FDA -- Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 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 (additional items listed in FDA's full record) -- and the recall number Z-1771-2026. If it matches, stop using or distributing it and contact Boston Scientific Corporation or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.
What this classification means
FDA classifies a recall as Class I when there is a reasonable probability that using the recalled product, or being exposed to it, will cause serious adverse health consequences or death. Class I is FDA's most serious recall classification. In this case, the recalling firm is Boston Scientific Corporation and the affected product is described in FDA's record as: Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 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 (additional items listed in FDA's full record). FDA's stated reason for the recall is: Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are (additional items listed in FDA's full record). The recall is tracked under FDA recall number Z-1771-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome.
Boston Scientific Corporation’s FDA history
Argus HQ has recorded 6 total FDA actions tied to Boston Scientific Corporation: 0 warning letters, 6 recalls, 0 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- What was recalled and why?
- Boston Scientific Corporation recalled Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 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 (additional items listed in FDA's full record). FDA's record states the reason for recall as: Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and.
- How serious is this recall?
- FDA classifies a recall as Class I when there is a reasonable probability that using the recalled product, or being exposed to it, will cause serious adverse health consequences or death. Class I is FDA's most serious recall classification.
- What should someone who has this product do?
- Because FDA has assigned this recall its highest severity classification, anyone who has this product should stop using it immediately, regardless of whether a problem has been noticed yet. Check the product against FDA's description (Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 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 (additional items listed in FDA's full record)) and.
- Has Boston Scientific Corporation had other FDA recalls or enforcement actions?
- Yes. Argus HQ has recorded 6 total FDA actions tied to Boston Scientific Corporation, including 6 recalls and 0 warning letters.
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Related enforcement actions
Full FDA history for Boston Scientific CorporationCompiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). Recall Record: Class I Recall: Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1.… by Boston Scientific Corporation. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-boston-scientific-corporation-z-1771-2026
"Recall Record: Class I Recall: Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1.… by Boston Scientific Corporation." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-boston-scientific-corporation-z-1771-2026.
Argus HQ Research. "Recall Record: Class I Recall: Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1.… by Boston Scientific Corporation." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-boston-scientific-corporation-z-1771-2026.
@misc{argushq_argushq_ai_recall_fda_recall_boston_scientific_corporation_z_1771_2026_2026,
title = {Recall Record: Class I Recall: Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1.… by Boston Scientific Corporation},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/recall/fda-recall-boston-scientific-corporation-z-1771-2026},
note = {Accessed: July 13, 2026}
}Source: FDA.gov — Recalls ↗