FDA Device Recalls

Class IOngoing

Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as: 1. ESSENTIO SR SL, Model Number L100; 2. ESSENTIO DR SL Pacemaker, Model Number L101; 3. ESSENTIO SR SL MRI Pacemaker, Model Number L110; 4. ESSENTIO DR SL MRI Pacemaker, Model Number L111; 5. ESSENTIO DR EL Pacemaker, Model Number L121; 6. ESSENTIO DR EL MRI Pacemaker, Model Number L131; 7. PROPONENT SR SL Pacemaker, Model Number L200; 8. PROPONENT DR SL Pacemaker, Model Number L201; 9. PROPONENT DR (VDD) SL Pacemaker, Model Number L209; 10. PROPONENT SR SL Pacemaker, Model Number L210; 11. PROPONENT DR SL MRI Pacemaker, Model Number L211; 12. PROPONENT DR EL Pacemaker, Model Number L221; 13. PROPONENT DR EL MRI Pacemaker, Model Number L231; 14. ACCOLADE SR SL Pacemaker, Model Number L300; 15. ACCOLADE DR SL Pacemaker, Model Number L301; 16. ACCOLADE SR SL MRI Pacemaker, Model Number L310; 17. ACCOLADE DR SL MRI Pacemaker, Model Number L311; 18. ACCOLADE DR EL Pacemaker, Model Number L321; 19. ACCOLADE DR EL MRI Pacemaker, Model Number L331; 20. ALTRUA 2 SR SL Pacemaker, Model Number S701; 21. ALTRUA 2 DR SL Pacemaker, Model Number S702; 22. ALTRUA 2 DR EL Pacemaker, Model Number S722.

Boston Scientific Corporation

Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia

March 19, 2026 · DeviceView details →

Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular blood pressure transducer

Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL MRI, Model Number U128; 3. VISIONIST CRT-P EL, Model Number U225; 4. VISIONIST CRT-P EL, Model Number U226; 5. VISIONIST CRT-P EL MRI, Model Number U228.

Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ

B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.

B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.

B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.

B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.

B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705.

B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096

Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case

Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.

Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.

Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.

Halyard CATH LAB kit. Model Number: SACL75-01.

Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.

Halyard CATH LAB kit. Model Number: SACL75AM.

Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.