VALITUDE CRT-P Pacemaker Recalled Due to Potential Accelerated Battery Depletion
Boston Scientific VALITUDE CRT-P pacemakers (models U125 and U128) may experience hydrogen release that compromises the capacitor, causing accelerated battery depletion. Patients should consult their healthcare provider.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored as High per the rubric criterion for risk-of-harm products where injury has not yet been reported. The defect affects a critical life-sustaining cardiac device and could result in device malfunction through accelerated battery depletion, but no illnesses or injuries have been documented.
Plain-English summary
Boston Scientific Corporation is recalling VALITUDE CRT-P cardiac pacemakers, models U125 and U128, distributed worldwide. A total of 6,377 units are affected.
The recall addresses a potential safety issue: latent release of small amounts of hydrogen inside the pacemaker may cause the low voltage capacitor to become electrically compromised over time. This can result in accelerated battery depletion and progression of the displayed battery depletion indicators.
Patients implanted with these devices should contact their healthcare provider to discuss the recall. Healthcare providers can identify affected devices by checking the model number (U125 or U128) and the device serial number.
The recalled product
- Product
- VALITUDE CRT-P pacemaker, Models: a) U125 b) U128
- Manufacturer
- Boston Scientific Corporation
- Hazard
- hydrogen-release
- capacitor-failure
- battery-depletion
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) U125
- Serial Numbers: 100009
- 100057
- 100074
- 100257
- 100521
- 700037
- 700061
- 700068
- 700074
- 700172
- 700179
- 700190
- 700253
- 702556
- 702777
- 702999
- 703683
- 703806
- 704048
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27