--- title: "Model Number L209 PROPONENT DR (VDD) SL Pacemaker — FDA record Z-0087-2026 | Is It on Recall" description: "Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance" url: https://isitonrecall.com/recall/fda-device-z-0087-2026-model-number-l209-proponent-dr-vdd-sl-pacemaker/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Model Number L209 PROPONENT DR (VDD) SL Pacemaker — FDA record Z-0087-2026 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Aug 20, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: Model Number L209 PROPONENT DR (VDD) SL Pacemaker - **Reason**: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). - **Classification**: Class I - **Recalling firm**: Boston Scientific Corporation - **Quantity**: 3146 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0087-2026 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0087-2026%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | GTIN 00802526559068, Serial Numbers: 100002, 100006, 100007, 100008, 100009, 100010, 100011, 100012, 100013, 100014, 100015, 100017, 100019, 100020, 100021, 100022, 100023, 100025, 100026, 100027, 100028, 100029, 100030, 100031, 100032, 100034, 100035, 100036, 100037, 100038, 100039, 100040, 100041, 100042, 100043, 100044, 100045, 100046, 100047, 100048, 100049, 100050, 100051, 100052, 100053, 100055, 100056, 100057, 100058, 100059, 100060, 100061, 100062, 100063, 100064, 100065, 100066, 100067, 100068, 100069, 100070, 100071, 100072, 100073, 100074, 100075, 100076, 100077, 100078, 100079, 100080, 100081, 100082, 100083, 100084, 100085, 100086, 100087, 100088, 100089, 100090, 100091, 100092, 100093, 100094, 100095, 100096, 100097, 100098, 100099, 100100, 100101, 100102, 100103, 100104, 100105, 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701592, 701594, 701595, 701596, 701599, 701602, 701604, 701605, 701606, 701608, 701609, 701610, 701612, 701613, 701614, 701615, 701616, 701617, 701619, 701620, 701622, 701623, 701624, 701625, ... | The agency lot list is longer than this excerpt. [Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0087-2026%22). Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Worldwide No US distribution state could be established from this record. Check the official notice. ## Dates in the source - **Report date**: Oct 22, 2025 - **Recall initiation date**: Aug 20, 2025 - **Center classification date**: Oct 10, 2025 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0087-2026%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Boston Scientific Corporation records](https://isitonrecall.com/brand/boston-scientific-corporation/)