Boston Scientific Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN recall — FDA Z-1100-2018
Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
Overview of recall records associated with Boston Scientific Corporation, including dates, categories and classifications where available.
Classification mix: Class II: 337, Class I: 121, Class III: 5.
Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant bleeding.
Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire functions in the start-up of the console. An incorrectly assembled trigger wire may result in…
Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire functions in the start-up of the console. An incorrectly assembled trigger wire may result in…
This page summarizes recall records in which the official source identifies Boston Scientific Corporation as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.