Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 68 of 138
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F AL3.0 SH, .070", REF SA6AL30SH. 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-2672-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F, MB1, 90CM, 070", REF SA6MB1D. 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-2596-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F, SR3.0, 100CM, 070", REF SA6SR30. 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-2607-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F, SR4.0 SH, 100CM, 070", REF SA6SR40SH. 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-2609-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F JL5.0 SH, .070", REF SA6JL50SH. 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-2665-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.0, .070", REF SA6JR40. 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-2618-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU3.5, 90CM.070", REF SA6EBU35D. 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-2577-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.0 SH, .070", REF SA6JL40SH. 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-2664-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP2.0 SH, .070", REF SA6CHAMP20SH. 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-2701-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F, NOTO SH, 100CM, 070", REF SA6NOTOSH. 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-2600-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F FR4.0, .070", REF SA6FR40. 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-2716-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F, FL4.0, 100CM.070", REF SA6FL40. 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-2579-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.0 SH, .070", REF SA6JL30SH. 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-2661-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.0 30o, .070", REF SA6MAC3030. 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-2694-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F MP1 SH, .070", REF SA6MP1SH. 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-2647-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F MP ST, .070", REF SA6MPST. 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-2669-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA SH, 100CM, 070", REF SA6IMASH. 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-2585-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F MB1, .070", REF SA6MB1. 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-2646-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.0 SH, .070", REF SA6EBU40SH. 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-2629-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F LARA, .070", REF SA6LARA. 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-2688-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP3.5, .070", REF SA6CHAMP35. 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-2743-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F MB2 SH, .070", REF SA6MB2SH. 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-2663-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR4.0, .070", REF SA6SCR40. 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-2719-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F MP1, .070", REF SA6MP1. 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-2657-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F RELAXED MOD HSII, .070", REF SA6RMHSII. 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-2727-2019 October 9, 2019 Danvers, MA