Recall Z-2003-2021 ยท NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
Boston Scientific Corporation
VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228
| Date | Jul 2, 2021 (initiated Jun 3, 2021) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 5920 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.