Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 70 of 138
Bard Peripheral Vascular Inc
Class II Terminated
EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913190, 16F, Straight, 19cm length, BARD, UDI: 00801741013836
Reason: 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.
Z-2377-2019 September 4, 2019 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397230, 14.5F, straight, 23cm length, BARD, UDI: 00801741012303
Reason: 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.
Z-2391-2019 September 4, 2019 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913350, 16F, Straight, 35cm length, BARD, UDI: 00801741013874
Reason: 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.
Z-2380-2019 September 4, 2019 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903190, 14.5F, Straight ,19cm length, BARD, UDI# 00801741013690
Reason: 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.
Z-2371-2019 September 4, 2019 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913270, 16F, Straight, 27cm length, BARD, UDI: 00801741013850
Reason: 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.
Z-2379-2019 September 4, 2019 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393270, 14.5F, Straight, 27cm length, BARD, UDI: 00801741012198
Reason: 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.
Z-2385-2019 September 4, 2019 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product Code:5905190, 14.5 Fr. Alphacurve Catheter with Standard Kit, 19 cm length, BARD, UDI# 00801741013799
Reason: 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.
Z-2368-2019 September 4, 2019 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393420, 14.5F, Straight, 42cm length, BARD, UDI: 00801741012228
Reason: 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.
Z-2386-2019 September 4, 2019 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397270, 14.5F, straight, 27cm length, BARD, UDI: 00801741012310
Reason: 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.
Z-2392-2019 September 4, 2019 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396190, 14.5F, Alphacurve, 19cm length, BARD, UDI: 00801741012242
Reason: 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.
Z-2387-2019 September 4, 2019 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396240, 14.5F, Alphacurve, 19cm length, BARD, UDI: 00801741012259
Reason: 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.
Z-2388-2019 September 4, 2019 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397350, 14.5F, straight, 35cm length, BARD, UDI: 00801741012334
Reason: 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.
Z-2394-2019 September 4, 2019 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396280, 14.5F, Alphacurve, 28cm length, BARD, UDI: 00801741012266
Reason: 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.
Z-2389-2019 September 4, 2019 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5904270, 14.5F, Straight ,27cm length, BARD, UDI: 00801741013775
Reason: 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.
Z-2375-2019 September 4, 2019 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393190, 14.5F, Straight, 19cm length, BARD, UDI: 00801741012174
Reason: 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.
Z-2383-2019 September 4, 2019 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905240, 14.5 Fr. Alphacurve Catheter with Standard Kit, 24cm length, BARD, UDI# 00801741013805
Reason: 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.
Z-2369-2019 September 4, 2019 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397190, 14.5F, straight, 19cm length, BARD, UDI: 00801741012297
Reason: 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.
Z-2390-2019 September 4, 2019 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903270, 14.5F, Straight ,27cm length, BARD, UDI: 00801741013713
Reason: 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.
Z-2373-2019 September 4, 2019 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903310, 14.5F, Straight ,31cm length, BARD, UDI: 00801741013720
Reason: 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.
Z-2374-2019 September 4, 2019 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905280, 14.5 Fr. Alphacurve Catheter with Standard Kit, 28cm length, BARD, UDI# 00801741013812
Reason: 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.
Z-2370-2019 September 4, 2019 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
EQUISTREAM XK Alphacurve Long-Term Hemodialysis Catheter REF/Product code:5915240, 16F, 24cm length, BARD, UDI: 00801741013904
Reason: 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.
Z-2376-2019 September 4, 2019 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903230, 14.5F, Straight ,23cm length, BARD, UDI: 00801741013706
Reason: 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.
Z-2372-2019 September 4, 2019 Tempe, AZ
Edwards Lifesciences, LLC
Class I Terminated
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260
Reason: 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 fr...
Z-2227-2019 August 28, 2019 Irvine, CA
Edwards Lifesciences, LLC
Class I Terminated
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23 UDI:00690103201246
Reason: 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 fr...
Z-2225-2019 August 28, 2019 Irvine, CA
Edwards Lifesciences, LLC
Class I Terminated
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (26mm) 9630TF26 UDI:00690103201253
Reason: 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 fr...
Z-2226-2019 August 28, 2019 Irvine, CA