Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro: recall status ⚠ Recalls found. Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro is named in 2 official recalls in our current data:
Source checks: October 22, 2026 at 6:00 PM UTC (oldest successful check).
Sources, dates and coverage limits We collect recent notices on a six-hour schedule using a rolling 90-day source request. Older retained records may also appear. This is a recall index, not a catalogue of all products or a complete recall history.
CPSC: stored recall dates April 30, 2026 to October 22, 2026. NHTSA: stored recall dates April 24, 2026 to October 19, 2026. FDA: stored recall dates April 29, 2026 to October 14, 2026. USDA FSIS is not aggregated here. Check USDA meat, poultry and processed egg notices . EPA and U.S. Coast Guard are not aggregated. Source delays and missing identifiers can prevent a match.
Brand Abiomed Recalls naming this model FDA Class I · Medical device · July 1, 2026
Potential for thrombus formation during prolonged use of the introducer.
Company / brand: Abiomed recalls
Affected product: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro recall status
Official ID Z-2601-2026 ·
Official record ↗
FDA Class I · Medical device · July 1, 2026
Potential for thrombus formation during prolonged use of the introducer.
Company / brand: Abiomed recalls
Affected product: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Pro recall status
Official ID Z-2602-2026 ·
Official record ↗
See all Abiomed recalls →
Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.