Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 69 of 138
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.75, .070", REF SA6EBU375. 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-2615-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F 3DRIGHT SH .070", REF SA63DRIGHTSH. 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-2649-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP2.0, .070", REF SA6CHAMP20. 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-2655-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F RBU4.5, .070", REF SA6RBU45. 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-2667-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.0, .070", REF SA6JL405. 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-2734-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB SH, .070", REF SA6LCBSH. 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-2735-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F SL3.0, .070", REF SA6SL30. 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-2746-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL3.5, 110CM, 070", REF SA6JL35A. 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-2588-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F SL4.0, .070", REF SA6SL40. 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-2631-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.0, .070", REF SA6JR405. 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-2670-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 55CM, 070", REF SA6JR40K. 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-2594-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD RIGHT SHORT TIP, .070", REF SA6ERADRST. 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-2730-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB, .070", REF SA6LCB. 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-2650-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F RCB SH, .070", REF SA6RCBSH. 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-2685-2019 October 9, 2019 Danvers, MA
Medtronic Vascular
Class I Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.0, .070", REF SA6AL205. 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-2745-2019 October 9, 2019 Danvers, MA
Arrow International Inc
Class II Terminated
8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters Product Code: CDC-29803-1A - Product Usage: The MACTM Two-Lumen Central Venous Access Device with ARROWg+ard Blue¿...
Reason: Products may contain the incorrect banner card within the kit
Z-2555-2019 October 2, 2019 Reading, PA
Arrow International Inc
Class II Terminated
Arrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kit Product Code:AK-42854-P1A - Product Usage: The Arrow Central Venous Catheters are intended to permit venous access to the central c...
Reason: Products may contain the incorrect banner card within the kit
Z-2556-2019 October 2, 2019 Reading, PA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Terminated
Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker.
Reason: Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the tether to release the Micr...
Z-2492-2019 September 18, 2019 Mounds View, MN
LeMaitre Vascular, Inc.
Class II Terminated
The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon sizes: 28 mm or 45mm. The single lumen acts as the inflation lumen for the balloon ...
Reason: incorrect device size being listed on the impacted device packaging
Z-2448-2019 September 11, 2019 Burlington, MA
Bard Peripheral Vascular Inc
Class II Terminated
EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913310, 16F, Straight, 31cm length, BARD, UDI: 00801741013867
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-2381-2019 September 4, 2019 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397500, 14.5F, straight, 50cm length, BARD, UDI: 00801741012358
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-2395-2019 September 4, 2019 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393230, 14.5F, Straight, 23cm length, BARD, UDI: 00801741012181
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-2384-2019 September 4, 2019 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913420, 16F, Straight, 42cm length, BARD, UDI: 00801741013881
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-2382-2019 September 4, 2019 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913230, 16F, Straight, 23cm length, BARD, UDI: 00801741013843
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-2378-2019 September 4, 2019 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397310, 14.5F, straight, 31cm length, BARD, UDI: 00801741012327
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-2393-2019 September 4, 2019 Tempe, AZ