Serious injuries or death may result from the use of these devices. The FDA has identified this as a Class I recall, the most serious type o

If your email program has trouble displaying this email, view as a webpage. Boston Scientific Recalls INGENIO Family of Pacemakers and CRT-Ps  Incorrect Transition to Safety Mode Boston Scientific is recalling INGENIO Family of Pacemakers (that includes models ADVANTIO DR EL, INGENIO DR EL and VITALIO DR EL) and cardiac resynchronization therapy pacemakers (CRT-Ps) due to the risk of incorrect transition to safety mode. Safety mode is intended to provide backup if the device is faulty. However, in safety mode, there is a risk of inappropriate loss of pacing due to sensing of muscle contractions. If the device incorrectly goes into safety mode, the device cannot be reprogrammed and must be replaced. The use of affected product may cause serious adverse health consequences, including loss of pacing or ability to regulate heart rate, worsening of heart failure and death. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Read More Questions? Customers in the U.S. with questions about this recall should contact Boston Scientific at 1-800-227-3422.

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