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editorial
. 2021 Nov 6;7(12):795–796. doi: 10.1016/j.hrcr.2021.11.005

Table 1.

Pacemaker generator Class I recall (1/2005–9/2021)

Manufacturer Device models Date of recall Recall terminated Mechanism of failure Number of units subject to recall
Guidant (Boston Scientific) Discovery, Meridian, Contak, Pulsar, Intelis, Virtus 7/28/05 1/5/07 Loss of hermetic seal in battery 54,688
Medtronic Sigma, Kappa 5/18/09 3/28/12 Bonding wires separating from terminal 85,378
Medtronic Adapta, Relia, Versa, Sensia, Sphera, Attesta, Vitatron 2/14/19 Open Software error 172,936
St Jude (Abbott) Assurity, Endurity 5/7/21 Open Moisture ingress through header 97,413
Boston Scientific Ingenio, Advantio, Vitalio 7/13/21 Open High internal battery impedance 72,466

Search terms on FDA recall database: pacemaker; pacing; electrode; battery; generator; lead; Jan 1, 2005 to Sept 10, 2021 (Courtesy of Faisal Merchant, MD).