Reason: 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 ACCO...
Z-0091-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
ACCOLADE SR SL MRI (Model L310)
Reason: 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 ACCO...
Z-0081-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Model Number L221 PROPONENT DR EL Pacemaker
Reason: 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 ACCO...
Z-0090-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
ACCOLADE DR SL MRI (Model L311)
Reason: 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 ACCO...
Z-0082-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Model Number U225 VISIONIST CRT-P EL
Reason: 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 ACCO...
Z-0103-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Model Number S702, ALTRUA 2 DR SL Pacemaker
Reason: 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 ACCO...
Z-0099-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
PROPONENT DR SL (Model L201)
Reason: 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 ACCO...
Z-0086-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Model Number L110, ESSENTIO SR SL MRI Pacemaker
Reason: 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 ACCO...
Z-0094-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Model Number L121 ESSENTIO DR EL Pacemaker
Reason: 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 ACCO...
Z-0096-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Model Number L210 PROPONENT SR SL Pacemaker
Reason: 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 ACCO...
Z-0088-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Model Number S722, ALTRUA 2 DR EL Pacemaker
Reason: 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 ACCO...
Z-0100-2026October 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Model Number U128, VALITUDE CRT-P EL MRI
Reason: 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 ACCO...
Z-0102-2026October 22, 2025Saint Paul, MN
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline Convenience kits used for various procedures: 1) CSTM PACEMAKER DRAPE PACK, Model Number: DYNJCD0339
Reason: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Z-1607-2025April 23, 2025Northfield, IL
Abbott Medical
Class IIOngoing
Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir leadless pacemaker system supports the implantati...
Reason: Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.
Z-1557-2025April 23, 2025Sylmar, CA
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline Convenience kits used for various procedures: 1) DR. KHAN CABG ADDS PACK, Model Number: DYNJ59310D; 2) CARDIAC STERNAL PACK, Model Number: DYNJ32436A; 3) VEIN CLOSURE PACK, Model Number: ...
Reason: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Z-1592-2025April 23, 2025Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088; 2) AV FISTULA PACK-LF, Pack Number DYNJ0131782J; 3) CABG, Pack Number DYNJ906462B; 4) CABG ACCESSORY PACK-LF, Pac...
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may...
Z-1438-2025April 2, 2025Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D; 2) ABD CLOSURE PACK, Pack Number DYNJ56987B; 3) ADULT PERC PACK-LF, Pack Number PHS170994005A; 4) BASIC PACK, Pa...
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may...
Z-1444-2025April 2, 2025Northfield, IL
Boston Scientific Corporation
Class IOngoing
VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)
Reason: A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other no...
Z-0827-2025January 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
Reason: A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other no...
Z-0825-2025January 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
Reason: A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other no...
Z-0822-2025January 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
Reason: A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other no...
Z-0823-2025January 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
Reason: A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other no...
Z-0824-2025January 22, 2025Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
Reason: A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other no...
Z-0826-2025January 22, 2025Saint Paul, MN
Abbott Medical
Class IIOngoing
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed ...
Reason: Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small...
Z-0753-2025January 1, 2025Sylmar, CA
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF, REF CDS840232L; 2) AVF-LF, REF CDS840233I; 3) GENERAL AAA #11-RF, REF CDS840261AB; 4) HEART CDS, REF CDS840387T; 5) OPEN HEART CDS PART...
Reason: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.