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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 6,377
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.
Part of a larger recall action
This product is one of 6 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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