Device recall: ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model…
Class I FDA enforcement event 95969. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Boston Scientific Corporation started this device recall on 12 Dec 2024. The firm address in the FDA record is in Saint Paul, MN. FDA put the recall in Class I. FDA event 95969 has 6 product records. The first FDA enforcement report date is 22 Jan 2025. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US (Nationwide) including Puerto Rico and US Virgin Islands and OUS (foreign) to countries of: Guam and Northern Mariana Islands.
Recalling firm
Boston Scientific Corporation, Saint Paul, MN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
6 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0822-2025 | ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331) | 156,329 units (59,937 US, 96,792 OUS) in total | Class I | Ongoing | 22 Jan 2025 |
| Z-0823-2025 | PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231). | 156,329 units (59,937 US, 96,792 OUS) in total | Class I | Ongoing | 22 Jan 2025 |
| Z-0824-2025 | ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131) | 156,329 units (59,937 US, 96,792 OUS) in total | Class I | Ongoing | 22 Jan 2025 |
| Z-0825-2025 | ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722) | 156,329 units (59,937 US, 96,792 OUS) in total | Class I | Ongoing | 22 Jan 2025 |
| Z-0826-2025 | VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128) | 156,329 units (59,937 US, 96,792 OUS) in total | Class I | Ongoing | 22 Jan 2025 |
| Z-0827-2025 | VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228) | 156,329 units (59,937 US, 96,792 OUS) in total | Class I | Ongoing | 22 Jan 2025 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2024
- 970
- Share of these events in Class I
- 11%
- Product records in this event
- 6Median of the firm: 2
- Events of the firm on the register
- 162
Other events of the firm
Official channels
- FDA enforcement report Z-0822-2025The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 95969. https://recallregister.com/fda/i/95969/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US (Nationwide) including Puerto Rico and US Virgin Islands and OUS (foreign) to countries of: Guam and Northern Mariana Islands.
- What quantity of product is in FDA event 95969?
- The event has 6 product records. The first record gives this quantity:
156,329 units (59,937 US, 96,792 OUS) in total
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2024 have the same class?
- 11% of the 970 device events that started in 2024 are in Class I.