PlainRecalls
FDA Devices Moderate Class II Ongoing

Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722

Reported: July 14, 2021 Initiated: June 3, 2021 #Z-2001-2021

Product Description

Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722

Reason for Recall

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.

Details

Units Affected
2952 units
Distribution
Worldwide distribution.
Location
Saint Paul, MN

Frequently Asked Questions

What product was recalled?
Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722. Recalled by Boston Scientific Corporation. Units affected: 2952 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 14, 2021. Severity: Moderate. Recall number: Z-2001-2021.