Boston Scientific Recalls

Hazard: Boston Scientific (BSC) has received complaints for cracked trays on the Encore device.

Hazard: The device can deliver an atypical amount of energy due to memory corruption inside the device.

Hazard: The device can deliver an atypical amount of energy due to memory corruption inside the device.

Hazard: The device can deliver an atypical amount of energy due to memory corruption inside the device.

Hazard: Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the balloon

Hazard: Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the balloon

Hazard: A field report indicated some units within this lot were missing the bottom pouch seal. The compromised seal is completely missing and is obvious to the user.

Hazard: Boston Scientific is initiating a voluntary removal of two lots of JETSTREAM SC 1.85mm and one lot of JETSTREAM XC 2.1mm Atherectomy Catheters due to these units being mislabeled. Some 1.85mm JETSTREAM SC catheters may have been labeled as 2.1mm catheters, and some 2.1mm JETSTREAM XC catheters may have been labeled as 1.85mm catheters.

Hazard: One lot of Imager II Angiographic Catheters is being recalled due to packaging mislabeling. The product may be labeled as Imager II Contra 2 curve catheters, when in fact the package contains Contra curve catheters.

Hazard: Boston Scientific has received field reports regarding the AngioJet Ultra 5000 A Console foot switch sticking during use resulting in an undesired continued operation of the device.

Hazard: There is a potential for radio frequency (RF) interference to alter wireless communication from a programmer, which in rare instances may cause an S-ICD to perform an unintended command. This behavior can only occur during an active, in-clinic interrogation/programming session with the Model 3200 S-ICD programmer. There is no risk of this behavior occurring when the LATITUDE Patient Management System communicates with an S-ICD in an ambulatory setting.

Hazard: Boston Scientific is conducting a recall on Boston Scientific INGEVITY" MRI endocardial pacing leads. There is a possibility that the polyurethane boot at the terminal end of the lead was not securely connected to the lead body.

Hazard: Five Accolate MRI and Essentio MRI DR pulse generators with an alternate MICS module configuration were shipped to US customers and implanted. This alternate configuration did not receive FDA approval yet.

Hazard: Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm diameter x 30mm

Hazard: Boston Scientific is recalling all models of Fetch 2 Aspiration Catheter as a result of receiving reports from the field of catheter shaft breaks; including cases requiring the use of a snare or other intervention to retrieve the http://webapps.cdrh.fda.gov/division-tracking/images/trash.pngbroken shaft from the patient.

Hazard: Boston Scientific is voluntarily implementing a Medical Device Recall of one batch of PT Graphix Magnet J-TIP Guidewires. Boston Scientific has found that, while the batch is labeled as a J-tip model, the guidewires are straight and do not have the pre-formed J-tip. The most severe injury expected to occur is a limited procedure delay caused by the need to replace the guidewire with one that has

Hazard: The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR pacemaker.

Hazard: The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR pacemaker.

Hazard: Potential for separation of the proximal handle from the shaft.

Hazard: During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in BSC's product risk documentation.

Hazard: During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in BSCs product risk documentation.

Hazard: During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in BSCs product risk documentation.

Hazard: During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in BSC's product risk documentation.

Hazard: Boston Scientific is voluntarily recalling its Chariot" Guiding Sheath. To date, Boston Scientific has received fourteen complaints for shaft separation, four for distal shaft separation. The most severe outcome of this failure is embolism of device fragments.

Hazard: Boston Scientific Corp. initiated a voluntary recall of specific lots of the EndoVive One Step Button, including the Decompression Tube and Low Profile Replacement Button devices because they may contain decompression tube adapters with a protrusion that could impede its ability to be introduced or removed from the PEG Button.

Hazard: Devices shipped to US in dual-channel rather than US approved single-channel RF Telemetry communication mode. While this does not impact therapy delivery of device; this can impact likelihood of successfully establishing telemetry during first scan of device when using a single-channel programmer. Telemetry can be established with additional scans; once established no further difficulty is expecte

Hazard: Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in conjunction with the Rotablator Rotational Atherectomy System because of complaints of wire fracture.

Hazard: Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in conjunction with the Rotablator Rotational Atherectomy System because of complaints of wire fracture.

Hazard: Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, possibly preventing subsequent sealing of the valve when desired. This Field Correction reinforces the Directions for Use (DFU) and gives further guidance on correct use of the hemostasis valve to avoid cross-threading and to securely seal the valve, minimizing potential for undesired blood leakage.

Hazard: Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, possibly preventing subsequent sealing of the valve when desired. This Field Correction reinforces the Directions for Use (DFU) and gives further guidance on correct use of the hemostasis valve to avoid cross-threading and to securely seal the valve, minimizing potential for undesired blood leakage.