TENACIO Pump with InhibiZone; UPN: 72404429;
Class I - DangerousWhat Should You Do?
- Check if you have this product: UPN: 72404429; UDI-DI: Lot numbers: 1100551131, 1100551132, 1100551134, 1100551135, 1100551136, 1100551137, 1100551139, 1100551145, 1100551149, 1100553579, 1100553580, 1100553582, 1100553583, 1100553584, 1100553585, 1100553586, 1100553588, 1100553589, 1100553590, 1100553591, 1100553594, 1100553595, 1100553596, 1100579593, 1100579596, 1100579598, 1100579599, 1100579600, 1100579639, 1100579640, 1100579642, 1100579643, 1100579646, 1100580141, 1100580143, 1100580144, 1100580145, 1100580146, 1100580149, 1100580598, 1100580599, 1100580600, 1100580601, 1100580605, 1100580608, 1100580609, 1100580610, 1100580612, 1100678770, 1100678774, 1100678775, 1100678776, 1100679129, 1100687128, 1100687130, 1100687133, 1100687134, 1100687135, 1100687140, 1100687142, 1100717769, 1100717773, 1100717774, 1100717775, 1100717776, 1100553592, 1100551147, 1100551138, 1100553597, 1100551146, 1100551142, 1100551148, 1100551141, 1100579595, 1100580147, 1100580606, 1100579641, 1100580607, 1100580595, 1100580603, 1100579601, 1100580148, 1100580597, 1100580596, 1100580613, 1100580611, 1100678777, 1100687129, 1100679130, 1100678773, 1100721233, 1100721238;
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Boston Scientific Corporation
- Reason for Recall:
- The potential for devices to experience inflation and/or deflation performance issues or difficulties.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
TENACIO Pump with InhibiZone; UPN: 72404429;
Product Codes/Lot Numbers:
UPN: 72404429; UDI-DI: Lot numbers: 1100551131, 1100551132, 1100551134, 1100551135, 1100551136, 1100551137, 1100551139, 1100551145, 1100551149, 1100553579, 1100553580, 1100553582, 1100553583, 1100553584, 1100553585, 1100553586, 1100553588, 1100553589, 1100553590, 1100553591, 1100553594, 1100553595, 1100553596, 1100579593, 1100579596, 1100579598, 1100579599, 1100579600, 1100579639, 1100579640, 1100579642, 1100579643, 1100579646, 1100580141, 1100580143, 1100580144, 1100580145, 1100580146, 1100580149, 1100580598, 1100580599, 1100580600, 1100580601, 1100580605, 1100580608, 1100580609, 1100580610, 1100580612, 1100678770, 1100678774, 1100678775, 1100678776, 1100679129, 1100687128, 1100687130, 1100687133, 1100687134, 1100687135, 1100687140, 1100687142, 1100717769, 1100717773, 1100717774, 1100717775, 1100717776, 1100553592, 1100551147, 1100551138, 1100553597, 1100551146, 1100551142, 1100551148, 1100551141, 1100579595, 1100580147, 1100580606, 1100579641, 1100580607, 1100580595, 1100580603, 1100579601, 1100580148, 1100580597, 1100580596, 1100580613, 1100580611, 1100678777, 1100687129, 1100679130, 1100678773, 1100721233, 1100721238;
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0138-2026
Related Recalls
Model Number L211 PROPONENT DR SL MRI Pacemaker
Boston Scientific
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Model Number S702, ALTRUA 2 DR SL Pacemaker
Boston Scientific
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Model Number U128, VALITUDE CRT-P EL MRI
Boston Scientific
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).