Device recall: ESSENTIO Pacemaker

Class II FDA enforcement event 81001. Recall start date: 10 Sep 2018. Status in the FDA record: Terminated. Termination date: 4 Nov 2019.

Reason for recall, in the words of FDA

Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Boston Scientific Corporation started this device recall on 10 Sep 2018. The firm address in the FDA record is in Saint Paul, MN. FDA put the recall in Class II. FDA event 81001 has 5 product records. The first FDA enforcement report date is 3 Oct 2018. The record gives the status Terminated, with the termination date 4 Nov 2019.

FDA enforcement report The 5 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.

AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, W A, WI, WV, and WY

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

5 product records in the event.

FDA event 81001: product records
Recall number	Product	Class	Status	Report date
Z-3255-2018	ESSENTIO Pacemaker	Class II	Terminated	3 Oct 2018
Z-3256-2018	PROPONENT Pacemaker	Class II	Terminated	3 Oct 2018
Z-3257-2018	ACCOLADE Pacemaker	Class II	Terminated	3 Oct 2018
Z-3258-2018	VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)	Class II	Terminated	3 Oct 2018
Z-3259-2018	VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)	Class II	Terminated	3 Oct 2018

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 II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2018: 1,074
Share of these events in Class II: 92%
Product records in this event: 5Median 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-3255-2018The 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 81001. https://recallregister.com/fda/ii/81001/. 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: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, W A, WI, WV, and WY
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2018 have the same class?: 92% of the 1,074 device events that started in 2018 are in Class II.
How many FDA recalls does Boston Scientific Corporation have?: Boston Scientific Corporation is the recalling firm in 162 enforcement events on this register. This event is 1 of them.