VALITUDE CRT-P pacemaker, Models: a) U125 b) U128
FDA device recall Z-2002-2021 · posted 2021-07-02 · Open, Classified
Recall details
- Recalling firm
- Boston Scientific Corporation
- 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.
- Action taken
- The firm began notifying its sales representatives on 06/02/2021 by email or hand delivery and followed with notifying the implanting/following physicians and centers on 06/03/2021 by letter. The letter explained the issue and provided recommendations for the physicians. Information is also posted on www.BostonScientific.com/advisory. Patient notification is done by the implanting/following physician.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- NKE
- Quantity affected
- 6377 units
- Distribution
- Worldwide distribution.
- Date initiated
- 2021-06-03
- Date posted
- 2021-07-02
- Location
- Saint Paul, MN
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