Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 56 of 138
Arrow International Inc
Class II Terminated
FlexTip Plus Epidural Catheterization Set, Product Code MP-17019-TIP
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1206-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
EPIDURAL CATHETERIZATION KIT, Product Code JC-05400-LB
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1204-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-04
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1197-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05400-CA1
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1179-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-12
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1199-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
EPIDURAL CATHETERIZATION KIT, Product Code UR-05501-EXP
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1215-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
FlexTip Plus Epidural Catheterization Set, Product Code AA-05400-E
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1171-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
EPIDURAL CATHETERIZATION KIT, Product Code BE-080180-BXL
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1191-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
FlexTip Plus Epidural Catheterization Kit, Product Code JC-05400-E
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1203-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05503-BID
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1182-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
EPIDURAL CATHETERIZATION KIT, Product Code UR-05501-FR1
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1216-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05500-TM
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1176-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-B
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1201-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
TheraCath Epidural Catheterization Kit, Product Code ASK-05001-SLR1
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1175-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
EPIDURAL CATHETERIZATION KIT, Product Code BJC-05400-BEN
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1218-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05501-SH
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1180-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-DCS
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1202-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
FlexTip Plus Epidural Catheterization Kit, Product Code AK-05500
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1177-2020 February 19, 2020 Reading, PA
Datascope Corporation
Class II Terminated
Reinforced Introducer Sets Maquet 7.5 Fr., Part Number: 068400040305. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic Balloon Catheters.
Reason: Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.
Z-0933-2020 February 12, 2020 Fairfield, NJ
Cook Inc.
Class II Terminated
Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844
Reason: The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
Z-0970-2020 February 12, 2020 Bloomington, IN
W. L. Gore & Associates Inc.
Class II Terminated
GORE¿ EXCLUDER¿ AAA Endoprosthesis
Reason: Firm has received reports of leading end catheter component separations.
Z-0995-2020 February 12, 2020 Phoenix, AZ
Centurion Medical Products Corporation
Class II Terminated
Centurion- UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT UVT1065 UMBILICAL VESSEL CATHETER TRAY UVT170 UMBILICAL VESSEL TRAY W/O CATHETER UVT280 UMBILICAL ARTERY TRAY UVT460 UMBILICAL CATHETER ...
Reason: Incomplete seals on the sterile package may compromise the sterility
Z-1094-2020 February 12, 2020 Williamston, MI
Cook Inc.
Class II Terminated
Angled Tip Ureteral Catheter Set, Ureteral Catheter, Global Product No. G14598
Reason: The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
Z-0965-2020 February 12, 2020 Bloomington, IN
W. L. Gore & Associates Inc.
Class II Terminated
GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE)
Reason: Firm has received reports of leading end catheter component separations.
Z-0996-2020 February 12, 2020 Phoenix, AZ
Datascope Corporation
Class II Terminated
Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It is an accessory to be used for percutaneous insertion of MAQUET Intra Aortic Balloon Catheters.
Reason: Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.
Z-0932-2020 February 12, 2020 Fairfield, NJ