Device recall: ACCOLADE SR SL (Model L300)

Class I FDA enforcement event 97467. Recall start date: 20 Aug 2025. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

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…

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 20 Aug 2025. The firm address in the FDA record is in Saint Paul, MN. FDA put the recall in Class I. FDA event 97467 has 27 product records. The first FDA enforcement report date is 22 Oct 2025. The record gives the status Ongoing.

FDA enforcement report The 27 product records

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 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide

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

27 product records in the event.

FDA event 97467: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0079-2026	ACCOLADE SR SL (Model L300)	16,077 units	Class I	Ongoing	22 Oct 2025
Z-0080-2026	ACCOLADE DR SL (Model L301)	32,695 units	Class I	Ongoing	22 Oct 2025
Z-0081-2026	ACCOLADE SR SL MRI (Model L310)	50,135 units	Class I	Ongoing	22 Oct 2025
Z-0082-2026	ACCOLADE DR SL MRI (Model L311)	90,931 units	Class I	Ongoing	22 Oct 2025
Z-0083-2026	ACCOLADE DR EL (Model L321)	7,488 units	Class I	Ongoing	22 Oct 2025
Z-0084-2026	ACCOLADE DR EL MRI (Model L331)	34,180 units	Class I	Ongoing	22 Oct 2025
Z-0085-2026	PROPONENT SR SL (Model L200)	1380 units	Class I	Ongoing	22 Oct 2025
Z-0086-2026	PROPONENT DR SL (Model L201)	2,426 units	Class I	Ongoing	22 Oct 2025
Z-0087-2026	Model Number L209 PROPONENT DR (VDD) SL Pacemaker	3146 units	Class I	Ongoing	22 Oct 2025
Z-0088-2026	Model Number L210 PROPONENT SR SL Pacemaker	41009 units	Class I	Ongoing	22 Oct 2025
Z-0089-2026	Model Number L211 PROPONENT DR SL MRI Pacemaker	106,536 units	Class I	Ongoing	22 Oct 2025
Z-0090-2026	Model Number L221 PROPONENT DR EL Pacemaker	3592 units	Class I	Ongoing	22 Oct 2025
Z-0091-2026	Model Number L231, PROPONENT DR EL MRI Pacemaker	63,851 units	Class I	Ongoing	22 Oct 2025
Z-0092-2026	Model Number L100, ESSENTIO SR SL Pacemaker	4827 units	Class I	Ongoing	22 Oct 2025
Z-0093-2026	Model Number L101, ESSENTIO DR SL Pacemaker	22,714 units	Class I	Ongoing	22 Oct 2025
Z-0094-2026	Model Number L110, ESSENTIO SR SL MRI Pacemaker	61,700 units	Class I	Ongoing	22 Oct 2025
Z-0095-2026	Model Number L111, ESSENTIO DR SL MRI Pacemaker	223,163 units	Class I	Ongoing	22 Oct 2025
Z-0096-2026	Model Number L121 ESSENTIO DR EL Pacemaker	10,833 units	Class I	Ongoing	22 Oct 2025
Z-0097-2026	Model Number L131, ESSENTIO DR EL MRI Pacemaker	190,088 units	Class I	Ongoing	22 Oct 2025
Z-0098-2026	Model Number S701 ALTRUA 2 SR SL Pacemaker	4841 units	Class I	Ongoing	22 Oct 2025
Z-0099-2026	Model Number S702, ALTRUA 2 DR SL Pacemaker	4055 units	Class I	Ongoing	22 Oct 2025
Z-0100-2026	Model Number S722, ALTRUA 2 DR EL Pacemaker	3376 units	Class I	Ongoing	22 Oct 2025
Z-0101-2026	Model Number U125, VALITUDE CRT-P EL	3620 units	Class I	Ongoing	22 Oct 2025
Z-0102-2026	Model Number U128, VALITUDE CRT-P EL MRI	28,911 units	Class I	Ongoing	22 Oct 2025
Z-0103-2026	Model Number U225 VISIONIST CRT-P EL	12,326 units	Class I	Ongoing	22 Oct 2025
Z-0104-2026	Model Number U226, VISIONIST CRT-P EL	1,050 units	Class I	Ongoing	22 Oct 2025
Z-0105-2026	Model Number U228, VISIONIST CRT-P EL MRI	41,191 units	Class I	Ongoing	22 Oct 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 2025: 945
Share of these events in Class I: 13%
Product records in this event: 27Median of the firm: 2
Events of the firm on the register: 162

Other events of the firm

Other FDA enforcement events of Boston Scientific Corporation
Initiated	Product (first record)	Type	Class	Records
6 Aug 2026	LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Ver	Device	Class II	3
22 Jul 2026	Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1)	Device	Class II	1
14 Jul 2026	OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.	Device	Class II	2
9 Jul 2026	Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter	Device	Class I	2
30 Jun 2026	Rapid Refill Continuous Injection System, UPN M00566001	Device	Class II	1
30 Jun 2026	Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20;	Device	Class II	3
19 Jun 2026	Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing Sys	Device	Class II	1
11 Jun 2026	FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, M	Device	Class II	4
11 Jun 2026	FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Cathet	Device	Class II	3
11 Jun 2026	FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Cathet	Device	Class II	1

Boston Scientific Corporation: all 162 events

Official channels

FDA enforcement report Z-0079-2026The 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.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 97467. https://recallregister.com/fda/i/97467/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

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: Worldwide
What quantity of product is in FDA event 97467?: The event has 27 product records. The first record gives this quantity: 16,077 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2025 have the same class?: 13% of the 945 device events that started in 2025 are in Class I.