Hazard
5 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 5 pacemaker malfunction recalls we have scored against our rubric, 1 (20%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (40%) are Severe.
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all pacemaker malfunction recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.
A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.
Boston Scientific ALTRUA 2 DR Pacemakers may unexpectedly enter Safety Mode during normal operation due to high battery impedance, potentially affecting device functionality.
Boston Scientific's ACCOLADE Family pacemakers, including VALITUDE CRT-P models, are recalled due to battery impedance defects that could trigger unintended Safety Mode during normal operation.
A software anomaly in Abbott's Merlin PCS 3650 programmer may prevent proper finalization of leadless pacemakers, causing loss of pacing function. The issue occurs when specific actions combine with brief telemetry loss.
Boston Scientific recalls dual chamber INGENIO family pacemakers and CRT-Ps with Extended Life batteries that may develop high internal impedance, causing Safety Mode and system resets, requiring device replacement.
Inpeco S.A. is recalling 679 laboratory automation systems because some modules are missing safety pacemaker labels. The recall addresses a risk of pacemaker malfunction for personnel working near the equipment.