FDA (Devices) recall action 88991

Boston Scientific Corporation recalled 8 products on 2021-12-08

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2021-12-08
Critical: 0
Units: —

Why these products were recalled

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

The agency’s own wording, quoted from the enforcement report.

1–8 of 8

HighFDA (Devices)··2021-12-08
Boston Scientific HURRICANE RX Dilation Balloon Recalled for Pressure Loss
Boston Scientific is recalling HURRICANE RX Dilation Balloons due to a pinhole defect that causes pressure loss during endoscopic procedures. The device may fail to maintain necessary pressure, potentially prolonging procedures.
Product
HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545950
Category
Distribution
0 states
HighFDA (Devices)··2021-12-08
Boston Scientific Hurricane RX Dilation Balloon Recalled for Pressure Loss
Boston Scientific is recalling Hurricane RX dilation balloons used in endoscopic biliary procedures due to pinhole defects causing pressure loss that may prolong treatment.
Product
HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545900
Category
Distribution
0 states
HighFDA (Devices)··2021-12-08
Boston Scientific Hurricane RX Dilation Balloons Recalled for Pressure Loss Defect
Boston Scientific is recalling specific lots of Hurricane RX Dilation Balloons due to a pinhole defect that causes pressure loss, resulting in prolonged endoscopic procedures. Affected devices are used for dilating strictures in the bile duct.
Product
HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890
Category
Distribution
0 states
HighFDA (Devices)··2021-12-08
Boston Scientific HURRICANE RX Dilation Balloon Pressure Loss Recalled
Boston Scientific is recalling HURRICANE RX Dilation Balloons across the US due to pinhole defects that cause pressure loss during endoscopic procedures. The defect may prolong procedures and affect patient safety.
Product
HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545920
Category
Distribution
0 states
HighFDA (Devices)··2021-12-08
FDA Recalls Hurricane RX Dilation Balloons for Pressure Failure Risk
Boston Scientific is recalling Hurricane RX Dilation Balloons nationwide due to pinhole defects that cause pressure loss or failure to maintain pressure during endoscopic procedures.
Product
HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545960
Category
Distribution
0 states
HighFDA (Devices)··2021-12-08
Hurricane RX Dilation Balloon Recalled for Pressure Loss Defect
Boston Scientific is recalling the Hurricane RX Dilation Balloon due to a pinhole defect causing pressure loss during endoscopic procedures. The defect may result in prolonged procedures and inability to effectively treat biliary strictures.
Product
HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:M00545910
Category
Distribution
0 states
HighFDA (Devices)··2021-12-08
Boston Scientific Hurricane RX Dilation Balloon Recalled for Pressure Loss Defect
Boston Scientific is recalling the Hurricane RX Dilation Balloon nationwide due to a pinhole defect causing loss of pressure or failure to maintain pressure during endoscopic procedures used to treat biliary strictures.
Product
HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545930
Category
Distribution
0 states
HighFDA (Devices)··2021-12-08
Hurricane RX Dilation Balloon Recalled Due to Pinhole Defect Causing Pressure Loss
Boston Scientific is recalling certain lots of the Hurricane RX Dilation Balloon due to a pinhole defect that causes loss of pressure or prevents the balloon from gaining or maintaining pressure during use, potentially prolonging medical procedures.
Product
HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545940
Category
Distribution
0 states