U.S. health regulators say a recalled Medtronic Inc. tissue device could cause more problems than originally thought, the company said Friday.

The device maker recalled its Octopus Nuvo Tissue Stabilizer in September because part of it could break, leading to fragments falling into patient chests and damaging the heart.
Food and Drug Administration officials now say “there is a a reasonable probability” that use of the recalled product will cause serious harm or even death and have upgraded it to a Class I recall, Medtronic said in a statement.

The device is used to help stabilize tissue during certain surgical procedures.

Health care facilities should stop using the devices, Medtronic said. It added that 571 have been distributed to in the United States, Europe and Canada and that it was working to retrieve them.