FDA (Devices) recall action 85815

Boston Scientific Corporation recalled 10 products on 2020-07-29

The FDA (Devices) publishes a recall like this one as 10 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 10 pages.

Products: 10
Announced: 2020-07-29
Critical: 0
Units: 27,355

Why these products were recalled

The needle surface deteriorated due to unexpected electrolysis during procedure.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–10 of 10

HighFDA (Devices)··2020-07-29
Boston Scientific Recalls IcePearl Cryoablation Needles Due to Surface Deterioration
Boston Scientific is recalling 48 IcePearl 2.1 CX Cryoablation Needles because the needle surface deteriorated due to unexpected electrolysis during procedures.
Product
Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
Category
Distribution
43 states
HighFDA (Devices)··2020-07-29
Boston Scientific Recalls Prostate Cryoablation Kits Due to Needle Surface Deterioration
Boston Scientific is recalling 71 IceFORCE 2.1 Prostate Cryoablation Kits because needle surfaces deteriorated due to unexpected electrolysis during procedures.
Product
Ablation Galil Technology, Three IceFORCE 2.1 Prostate Cyroablation Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
Category
Distribution
43 states
HighFDA (Devices)··2020-07-29
Boston Scientific Recalls IceFORCE Prostate Kit Due to Needle Surface Deterioration
Boston Scientific is recalling 79 IceFORCE 2.1 CX Prostate Kits because needle surfaces deteriorated due to unexpected electrolysis during procedures.
Product
Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
Category
Distribution
43 states
HighFDA (Devices)··2020-07-29
Boston Scientific Recalls IceFORCE Cryoablation Needles Due to Surface Deterioration
Boston Scientific is recalling 18,440 IceFORCE 2.1 CX 90 Needle Cryoablation Needles because the needle surface deteriorated due to unexpected electrolysis during procedures.
Product
Ablation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
Category
Distribution
43 states
HighFDA (Devices)··2020-07-29
Boston Scientific Recalls Prostate Cryoablation Kits Due to Needle Deterioration
Boston Scientific is recalling 88 Prostate Cryoablation Kits because needle surfaces deteriorated during procedures due to unexpected electrolysis.
Product
Ablation Galil Technology, Three IceFORCE 2.1 CX Prostate Cyroablation Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
Category
Distribution
43 states
HighFDA (Devices)··2020-07-29
Boston Scientific Recalls IcePearl Cryoablation Needles Due to Surface Deterioration
Boston Scientific is recalling IcePearl 2.0 CX 90 Cryoablation Needles because the needle surface deteriorated due to unexpected electrolysis during procedures.
Product
Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
Category
Distribution
43 states
HighFDA (Devices)··2020-07-29
Boston Scientific Recalls IcePearl 2.1 CX Prostate Kit Due to Needle Deterioration
Boston Scientific is recalling 193 IcePearl 2.1 CX Prostate Kits because needle surfaces deteriorated due to unexpected electrolysis during procedures.
Product
Ablation Galil Technology, IcePearl¿2.1 CX Prostate¿Kit Visual Ice System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
Category
Distribution
43 states
HighFDA (Devices)··2020-07-29
Boston Scientific Recalls IceForce 2.1 CX Cryoablation Needles
Boston Scientific is recalling 656 IceForce 2.1 CX Cryoablation Needles because the needle surface deteriorated due to unexpected electrolysis during procedures.
Product
Ablation Galil Technology, IceForce 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
Category
Distribution
43 states
HighFDA (Devices)··2020-07-29
Boston Scientific Recalls IcePearl Cryoablation Needles Due to Surface Deterioration
Boston Scientific is recalling 205 IcePearl 2.1 CX Cryoablation Needles because the needle surface deteriorated due to unexpected electrolysis during procedures.
Product
Ablation Galil Technology, IcePearl 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
Category
Distribution
43 states
HighFDA (Devices)··2020-07-29
Boston Scientific Recalls IceFORCE 2.1 CX Cryoablation Needles
Boston Scientific is recalling 39 IceFORCE 2.1 CX Cryoablation Needles because the needle surface deteriorated due to unexpected electrolysis during procedures.
Product
Ablation Galil Technology, IceFORCE 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
Category
Distribution
43 states