American Pacemaker Corp. announced yesterday that it is recalling 552 pacemakers that have been implanted in the chests of people with heart trouble.
In a statement, the firm said the model 1613 pacemakers "may contain defective transistors supplied by an outside vendor."
The pacemakers, which help regulate the heartbeat, should be removed from patients and replaced "in cases where it would be consistent with good patient management," the company said.
The firm said the Food and Drug Administration is reviewing the defective pacemakers.
The government announced the recall yesterday of nearly 2,400 intraocular lenses, which are similar to contact lenses but are surgically implanted in the damaged eyes of cataract patients whose natural lenses have been removed.
At least 56 people have suffered eye problems due to the defective lenses, an announcement said.
The Food and Drug Administration said the latest lens recalled involved Medallion Intraocular Lenses manufactured by Medical Workshop of Groningen, Holland, and sold to hospitals and physicians throughout the United States through the firm's U.S. distributor.
The FDA, which last December reported a batch of 716 Medallion lenses was being recalled because of apparent adverse effects, said yesterday that six subsequent lots involving 2,394 lenses are being recalled by the company.
Nancy Glick, an FDA spokesman, said hospitals and doctors have been advised to return any unused lenses from lots 809.05, 809.15, 809.12, 809.29, 811.06 and 812.08 to the distributor in Fort Lauderdale, Fla. Physicians who already have implanted defective lenses should monitor their patients carefully for symptoms of hypopyn, a collection of pus in the rear chamber of the eye, she said.
Other recalls announced yesterday included a massive worldwide callback of practically all Quinton brand sterile products used for kidney treatment and dialysis. The agency said 169 different types of catheters, shunts and related devices involving several hundred thousand individual items are involved.
Glick said the manufacturer, Quiton Instruments Co. of Seattle, initiated the recall after discovering defective seals on several supposedly sterile packages. All products with red or blue labels are being recalled. The firm began putting brown labels on products packaged after the problem was corrected.