Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 62 of 138
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.0 SH, .070", REF SA6CHAMP10SH. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2695-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.0 SH, 110CM, .070" REF SA6JR40SHA. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2612-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL2.0 SH, .070", REF SA6SAL20SH. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2723-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F JL6.0, .070", REF SA6JL60. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2648-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F, PK1, 47CM, 070", REF SA6PK1W. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2601-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F JCL4.0, .070", REF SA6JCL40. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2736-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0 100CM.070", REF SA6AR10. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2569-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.0 SH, .070", REF SA6SAL10SH. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2705-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F EL GAMAL SH, .070", REF SA6ELGAMALSH. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2699-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU3.5, 110CM.070", REF SA6EBU35A. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2576-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F SL4.5, .070", REF SA6SL45. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2690-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL.75, .070", REF SA6SAL75. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2742-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR3.5 SH, .070", REF SA6ECR35SH. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2714-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB 90CM, .070", REF SA6LCBD. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2751-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR4.0 SH, .070", REF SA6SCR40SH. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2637-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F HSIII, .070", REF SA6HSIII. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2702-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F, SR4.0, 100CM, 070", REF SA6SR40. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2608-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F RBU4.0, .070", REF SA6RBU40. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2651-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU4.0, 110CM.070", REF SA6EBU40A. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2578-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.0, .070", REF SA6SAL10. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2671-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR5.0, .070", REF SA6SCR50. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2728-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F JR3.0 SH, .070", REF SA6JR30SH. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2721-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F, 3DRC 100CM .070", REF SA63DRC. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2564-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL4.0, 110CM, 070", REF SA6JL40A. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2589-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL.75 110CM.070", REF SA6AL75A. for cardiovascular use
Reason: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Z-2568-2019 October 9, 2019 Danvers, MA