Class I - Dangerous
The seal integrity of the sterile bag containing the kits may be compromised.
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Surgical Instruments
🏥 Medical Devices • 6,839 recalls
EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903270, 14.5F, Straight ,27cm length, BARD, UDI: 00801741013713
Bard Peripheral Vascular
Class I - Dangerous
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913310, 16F, Straight, 31cm length, BARD, UDI: 00801741013867
Bard Peripheral Vascular
Class I - Dangerous
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905280, 14.5 Fr. Alphacurve Catheter with Standard Kit, 28cm length, BARD, UDI# 00801741013812
Bard Peripheral Vascular
Class I - Dangerous
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
The seal integrity of the sterile bag containing the kits may be compromised.
GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393230, 14.5F, Straight, 23cm length, BARD, UDI: 00801741012181
Bard Peripheral Vascular
Class I - Dangerous
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260
Edwards Lifesciences
Class I - Dangerous
The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the patient during procedures
QIAsymphony software version 5.0.3 - Software issue incorreclty assigns the 2D bar code eluate ID to the sample within the results file. If 2D bar code eluate IDs are not checked against the sample ID prior to downstream application the incorrect tube may be selected and it could have the potential to lead to delayed results or incorrect patient reporting
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23 UDI:00690103201246
Edwards Lifesciences
Class I - Dangerous
The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the patient during procedures
Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers.
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (26mm) 9630TF26 UDI:00690103201253
Edwards Lifesciences
Class I - Dangerous
The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the patient during procedures
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239
Edwards Lifesciences
Class I - Dangerous
The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the patient during procedures
Class I - Dangerous
Manufacturing flaw in the sterile barrier system
Class I - Dangerous
Manufacturing flaw in the sterile barrier system
Class I - Dangerous
Manufacturing flaw in the sterile barrier system
Class I - Dangerous
Manufacturing flaw in the sterile barrier system
15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body
15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body
Class I - Dangerous
Manufacturing flaw in the sterile barrier system
Class I - Dangerous
Manufacturing flaw in the sterile barrier system