Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 54 of 138
Abbott Vascular
Class I Terminated
NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion...
Reason: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1130-2020 February 26, 2020 Temecula, CA
Arrow International Inc
Class II Terminated
Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05500-CAN
Reason: Product lidstock contains the incorrect expiration date for the product
Z-1238-2020 February 26, 2020 Reading, PA
Arrow International Inc
Class II Terminated
Arrow EPIDURAL CATHETERIZATION KIT YC-02220
Reason: Product lidstock contains the incorrect expiration date for the product
Z-1246-2020 February 26, 2020 Reading, PA
Arrow International Inc
Class II Terminated
Arrow Central Venous Catheterization Kit ASK-04200-UPM
Reason: Product lidstock contains the incorrect expiration date for the product
Z-1243-2020 February 26, 2020 Reading, PA
Abbott Vascular
Class I Terminated
NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion ...
Reason: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1136-2020 February 26, 2020 Temecula, CA
Arrow International Inc
Class II Terminated
Arrow FlexTip Plus(R) Combined Spinal Epidural Catheterization Kit ASK-05560-WH
Reason: Product lidstock contains the incorrect expiration date for the product
Z-1239-2020 February 26, 2020 Reading, PA
Abbott Vascular
Class I Terminated
NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion...
Reason: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1134-2020 February 26, 2020 Temecula, CA
Abbott Vascular
Class I Terminated
NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler RX 4.5 X 12MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United ...
Reason: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1144-2020 February 26, 2020 Temecula, CA
Abbott Vascular
Class I Terminated
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion o...
Reason: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1133-2020 February 26, 2020 Temecula, CA
Abbott Vascular
Class I Terminated
NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler RX 4.0 X 8MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United ...
Reason: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1140-2020 February 26, 2020 Temecula, CA
Abbott Vascular
Class I Terminated
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion ...
Reason: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1132-2020 February 26, 2020 Temecula, CA
Arrow International Inc
Class II Terminated
Arrow EPIDURAL CATHETERIZATION KIT CK-02220
Reason: Product lidstock contains the incorrect expiration date for the product
Z-1249-2020 February 26, 2020 Reading, PA
Abbott Vascular
Class I Terminated
NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00 X 12MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion...
Reason: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1137-2020 February 26, 2020 Temecula, CA
Abbott Vascular
Class I Terminated
NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler RX 4.0 X 15MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United...
Reason: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1142-2020 February 26, 2020 Temecula, CA
Abbott Vascular
Class I Terminated
NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion...
Reason: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1135-2020 February 26, 2020 Temecula, CA
Arrow International Inc
Class II Terminated
Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSC
Reason: Product lidstock contains the incorrect expiration date for the product
Z-1237-2020 February 26, 2020 Reading, PA
Abbott Vascular
Class I Terminated
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion...
Reason: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1131-2020 February 26, 2020 Temecula, CA
Arrow International Inc
Class II Terminated
Arrow EPIDURAL CATHETERIZATION COMPONENT EC-05000
Reason: Product lidstock contains the incorrect expiration date for the product
Z-1251-2020 February 26, 2020 Reading, PA
Arrow International Inc
Class II Terminated
Arrow PSI Kit for use with 7 - 7.5 Fr. Catheters ASK-09801-UPM
Reason: Product lidstock contains the incorrect expiration date for the product
Z-1242-2020 February 26, 2020 Reading, PA
Arrow International Inc
Class II Terminated
EPIDURAL CATHETERIZATION KIT, Product Code MTO-09903-KU
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-1210-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
EPIDURAL CATHETERIZATION KIT, Product Code BE-05400-DCSHO
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-1190-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
EPIDURAL CATHETERIZATION KIT, Product Code IT-05400-DC
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-1200-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
EPIDURAL CATHETERIZATION KIT, Product Code ALZANO-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-1173-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
FlexTip Plus Epidural Catheterization Kit, Product Code AK-05501
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-1172-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-WH
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-1184-2020 February 19, 2020 Reading, PA