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Heart defibrillator implants that weren't made in compliance with U.S. Food and Drug Administration regulations are being recalled by medical device maker Boston Scientific.
The company said Monday that it had identified device production changes that weren't submitted to the FDA, the Associated Press reported.
There's "no indication that the manufacturing process changes pose any risk to patient safety," according to Boston Scientific.
Implanted defibrillators monitor the heart for dangerous irregular heartbeats and use electrical shocks to restore normal heart rhythm. About one-quarter of implanted defibrillators used worldwide are made by Boston Scientific, the AP reported.