Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 67 of 138
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F RRAD, .070", REF SA6RRAD. 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-2712-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F ALR1-2 SH, .070", REF SA6ALR12SH. 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-2689-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0 SH, 100CM.070", REF SA6AR20SH. 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-2572-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT, LONG TIP, .070", REF SA6ERADLLT. 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-2674-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.5 SH, .070", REF SA6MAC35SH. 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-2676-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.5, .070:, REF SA6AL25. 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-2700-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC5.0, .070", REF SA6MAC50. 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-2733-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F SAR1.0, .070", REF SA6SAR10. 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-2703-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F EL GAMAL, .070", REF SA6ELGAMAL. 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-2740-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL3.0, .070", REF SA6SAL30. 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-2720-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC 3.5, .070", REF SA6MAC35. 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-2675-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.5, .070", REF SA6JR45. 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-2630-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR4.0 SH, .070", REF SA6ECR40SH. 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-2692-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F, MP1, 55CM, 070", REF SA6MP1K. 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-2597-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 90CM.070", REF SA6AL10D. 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-2566-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.5 SH, .070", REF SA6EBU45SH. 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-2656-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.5, .070", REF SA6EBU30. 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-2622-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.0, .070", REF SA6CHAMP10. 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-2654-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F, HSI, 100CM, 070", REF SA6HSI. 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-2581-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.5, .070", REF SA6EBU45. 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-2633-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0SH 100CM.070", REF SA6AR10SH. 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-2570-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.5, .070", REF SA6SAL15. 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-2741-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU5.0, .070", REF SA6EBU50. 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-2640-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F, MPH, 55CM, 070", REF SA6MPHK. 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-2598-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR4.0, .070", REF SA6ECR40. 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-2731-2019 October 9, 2019 Danvers, MA