- Boston Scientific Corporation BSX is recalling Ingenio family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) devices due to the risk of incorrect transition to safety mode.
- The devices are used in patients who have low heart rates and with moderate to severe heart failure. Safety mode is intended to provide backup if the device is faulty.
- However, there is a risk of inappropriate loss of pacing in safety mode due to sensing muscle contractions.
- The use of the defective product may cause serious adverse health consequences, including early device replacement, loss of pacing or ability to regulate heart rate, worsening of heart failure, and death.
- There have been 65 reported incidents, including three injuries that required patients to receive temporary external pacing. There have been no reports of death.
- Boston Scientific has recalled 48,000 in the U.S.
- Price Action: BSX shares closed up 0.10% at $44.70 on Friday.
- Related content: Benzinga's Full FDA Calendar.
- Photo by company website
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