Reported Oct 22, 2025 · Ongoing
Model Number S702, ALTRUA 2 DR SL Pacemaker
Boston Scientific Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 4100 Hamline Ave N · Saint Paul, MN · 55112-5700
Is this the product you have?
Model Number S702ALTRUA 2 DR SL Pacemaker
- Lot codes and dates
- GTIN 00802526559358
- Serial numbers
2,742 of 2,742 codes
100002100003100004100005100006100007100008100009100010100011100012100013100014100015100016100017100018100020100021100025100026100028100029100030100031100032100033100034100035100036100037100038100040100042100045100046100050100051100052100053100054100055100056100057100058100059100060100061100062100063100064100065100066100067100068100069100070100071100072100073
- Serial Numbers
270 of 270 codes
100385100419100483100502100508100537100542100547100584100629100714100716100734100761100798700003700008700010700012700015700016700017700019700021700022700023700024700031700032700034700035700036700041700043700045700047700048700049700051700052700054700055700057700061700062700064700066700070700072700085700090700093700094700098700106700112700119700120700121700125
- Serial Numbers
280 of 280 codes
100827100834100840100868100880100888100890100896100900100904100905100908100925100926100927100928100930100931100933100935100936100939100940100944700207700211700229700243700249700257700259700263700264700266700271700272700275700291700296700297700302700304700312700322700326700329700333700378700435700503700586700745701099701127701290701380701384701390701413701423
- Serial Numbers
755 of 755 codes
100573100680100849100850100858100860100865100875100911700323700444700446700484700496700546700624700627700670700673700696700726700781700791700799700823700906701021701031701063701075701077701078701102701108701111701115701117701121701126701128701129701130701131701132701136701138701144701146701154701155701156701161701163701165701166701167701173701175701182701193
- Serial numbers
70173070173170173270
- Amount recalled
- 4055 units
This recall covers 34 products
The agency filed one notice per product. You are reading one of them; the other 33 are below.
21 more are in the archive.
Why it was recalled
Stop using this product now
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).
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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