VALITUDE CRT-P pacemaker, Models: a) U125 b) U128
Reported: July 14, 2021 Initiated: June 3, 2021 #Z-2002-2021
Product Description
VALITUDE CRT-P pacemaker, Models: a) U125 b) U128
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
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 6377 units
- Distribution
- Worldwide distribution.
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
VALITUDE CRT-P pacemaker, Models: a) U125 b) U128. Recalled by Boston Scientific Corporation. Units affected: 6377 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-2002-2021.
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