Medical device recalls

The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.

Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.

Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.

Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.

Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.

Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.

It was discovered that in certain situations, including partial sessions and when taking adhoc measurements, the patient data was not synchronizing in a timely manner with the backend database, resulting in the patient's clinician not getting patient data tor one or two days.

Under certain circumstances, the firmware makes it possible for the Disinfection unit UV (432332-9020-000) to activate outside of the Celldiscoverer 7 housing. This may result in exposure of the users to harmful UV radiation.

The product may be packaged with the incorrect length of feeding tube as labeled.

Possible diminished performance prior to its established expiration date.

The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is autodiluted onboard the system, due to a reduced volume of diluent being pipetted from the vial.

The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is autodiluted onboard the system, due to a reduced volume of diluent being pipetted from the vial.

The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is autodiluted onboard the system, due to a reduced volume of diluent being pipetted from the vial.

SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.

Following pressurization of the devices, damage to the device handle mechanism may occur, accompanied by a loud noise and potential dispersion of plastic fragments and components.

Following pressurization of the devices, damage to the device handle mechanism may occur, accompanied by a loud noise and potential dispersion of plastic fragments and components.

This voluntary recall is being conducted due to the curved tip introducer needle which is included in the kit, to have a potential manufacturing defect. This could result in difficulty advancing or withdrawing the Vectris lead through the curved tip introducer needle.

This voluntary recall is being conducted due to the curved tip introducer needle which is included in the kit, to have a potential manufacturing defect. This could result in difficulty advancing or withdrawing the Vectris lead through the curved tip introducer needle.

The label on Apollo XT 5.5mm Suture Anchor (part # XTS-5515; lots 2358, 2362, and 2363) indicated that the anchor screw material was titanium, however that part number is made of PEEK.

Product has a nominal ocular hazard distance (NOHD) that is longer than specified and persons could be exposed to light in excess of the exposure limit.

Increase of events affecting performance regarding pump clogging and displacement of the color-coded SPR label (DOT). These performance issues could contribute to erroneous results for any assay performed on the VIDAS¿ and mini VIDAS¿ system due to a decrease of pipetted volume.

Increase of events affecting performance regarding pump clogging and displacement of the color-coded SPR label (DOT). These performance issues could contribute to erroneous results for any assay performed on the VIDAS¿ and mini VIDAS¿ system due to a decrease of pipetted volume.

Devices were found with a sterile breach (puncture) in the pouch from a sort of 8,064 packaged devices.

Thrombogenicity test results demonstrated that both the test devices (SSS) and control devices (OM) did not meet the internal specification of non-thrombogenic .

To correct the kit's instructions for use as the storage time for gastric and gastroesophageal junction adenocarcinoma cut sections will be changed from six months to five months.

Correction vector confirmation message is lost if access point is changed after sending the correction vector. As a result, the patient will be treated in the setup position or treatment position instead of the corrected position.

Hyalomatrix products are susceptible to degradation as a result of the decomposition of PVC in the packaging material during sterilization, which resulted in degradation of the film. Over the long term it is possible that product integrity may be compromised.

Potential for AperFix 24 mm implant breaking inside the drilled femoral socket.

Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter defibrillators (ICDs) as they near elective replacement indicator (ERI) voltage. Under certain circumstances, the device may display an immediate End of Life (EOL) Observation with no prior ERI alert. Though no ERI alert is triggered, there may not be enough remaining battery capacity to charge the high voltage circuits, resulting in an excessive charge time EOL Observation, leading to a loss of high voltage and anti-tachycardia pacing therapy.

Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter defibrillators (ICDs) as they near elective replacement indicator (ERI) voltage. Under certain circumstances, the device may display an immediate End of Life (EOL) Observation with no prior ERI alert. Though no ERI alert is triggered, there may not be enough remaining battery capacity to charge the high voltage circuits, resulting in an excessive charge time EOL Observation, leading to a loss of high voltage and anti-tachycardia pacing therapy.