Reported Jul 14, 2021 · Ongoing
Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 Bldg 3 · Saint Paul, MN · 55112-5700
Is this the product you have?
- Altrua 2 pacemaker
- Modelsa) S701 b) S702 c) S722
- Lot codes and dates
- a) S701
- Serial Numbers
1,053 of 1,053 codes
100005100011100012100015100017100021100022100028100032100034100037100053100055100059100060100068100075100079100082100083100090100095100098100103100106100116100119100122100124100128100132100135100139100141100148100149100205100208100211100213100221100230100231100232100234100236100238100239100245100247100251100252100254100255100262100265100269100303100305100306
- Serial Numbers
1,563 of 1,563 codes
100010100042100054100082100084100097100101100111100119100126100146100148100152100155100165100167100172100173100174100182100184100191100194100196100203100206100207100208100209100210100215100219100221100223100229100232100235100237100239100242100243100246100255100257100258100261100262100270100273100277100286100290100292100293100297100298100312100319100327100330
- Serial Numbers
336 of 336 codes
100002100006100008100011100012100014100015100020100022100025100026100030100032100035100036100037100038100039100041100046100048100052100053100057100059100060100061100064100066100067100068100070100071100072100073100075100076100077100080100081100084100086100088100090100091100092100094100096700001700004700005700006700008700009700011700014700032700033700034700035
- Amount recalled
- 2952 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Why it was recalled
Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.
This product could cause temporary or reversible health problems — stop using it.
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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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