Safety Alerts

October 8, 2019 - On October 3, 2019, Medtronic began notifying healthcare professionals that a subset of pacemakers and implantable cardioverter defibrillators (including CRT and Micra TPS devices) manufactured between October 2018 and April 2019 may display an inaccurately short estimate of battery longevity. 

August 21, 2019 - Boston Scientific released an Urgent Medical Device Advisory regarding the performance of approximately 400 Model A209/A219 EMBLEM™ Subcutaneous Implantable Cardioverter Defibrillators (S-ICD) worldwide, manufactured in July 2017.  

May 7, 2019 - The U.S. Food and Drug Administration issued a safety communication to inform patients and health care professionals about the potential for the batteries of certain Medtronic implantable pacemakers to drain more quickly than expected and without warning to patients.

March 25, 2019 - Medtronic has identified potential vulnerabilities to wireless technologies (Conexus telemetry) used to monitor certain ICDs, CRT-Ds, and programmers. Medtronic highlights that no cases of cyberattack, privacy breech, or patient harm have been observed or associated with these vulnerabilities. 

January 22, 2019 - On January 17, 2019, Medtronic issued an urgent voluntary recall and distribution suspension affecting a subset of dual-chamber pacemakers distributed worldwide between March 10, 2017 and January 7, 2019, including the brand names:AdaptaTM, Versa^TM, and Sensia^TM (USA); Relia^TM, Attesta^TM, Sphera^TM, and Vitatron^TM A/E/G/Q series (outside of USA).

January 15, 2019 (Update) - The FDA approved a new software for the  ZOLL LifeVest 4000 for patient alerts when a “Call for service – Message Code 102” is displayed. The potential hazard of the device failing to deliver treatment to a patient if the device is not replaced soon after displaying a “Call for service – Message Code 102” was previously described in the January 17, 2018 FDA Safety Communication and an update on July 25, 2018.

January 15, 2019 - The FDA approved a new software for the  ZOLL LifeVest 4000 for patient alerts when a “Call for service – Message Code 102” is displayed. The potential hazard of the device failing to deliver treatment to a patient if the device is not replaced soon after displaying a “Call for service – Message Code 102” was previously described in the January 17, 2018 FDA Safety Communication and an update on July 25, 2018.

November 5, 2018 - Boston Scientific released a product advisory related to accelerated battery depletion and a shortened replacement interval observed in some of the first generation Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) system SQ-RX™ Model 1010 Pulse Generators (PG) (acquired from Cameron Health Incorporated).  There have been no reports of related injury. This safety risk is not applicable to the EMBLEM™ MRI or EMBLEM S-ICD.

June 22, 2018 - Medtronic released a software update to prevent possible device reset to RV only pacing at 65 bpm for the Percepta family of CRT pacemakers. 

Due to a potential timing interaction between the EffectivCRT Diagnostic and the Ventricular Safety Pacing feature (VSP) of the Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan, Medtronic has determined that certain devices may revert to RV-only VVI pacing at 65 bpm. Approximately 7,803 devices in the USA are affected.

Medtronic announced an urgent medical device recall affecting approximately 2,770 (209 confirmed active in the U.S.) EnTrust ICDs due to the potential for loss of high voltage and ATP therapy as they near elective replacement indicator (ERI) stage. This model was last manufactured in 2010. Twenty-five devices have experienced a charge time out due to reaching End of Life (EOL) with no (21) or abbreviated (4) ERI stage. To date, there have been no patient deaths or complications due to this issue.