Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 53 of 138
Bard Peripheral Vascular Inc
Class II Terminated
BardPort M.R.I. Hard Base Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter, Ref: 0604550, UDI: (01)00801741025860 Product Usage: Bard implantable ports are indicated for...
Reason: Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9....
Z-1577-2020 April 1, 2020 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
BardPort Titanium Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter , REF: 0602230, UDI: (01)00801741025563 Product Usage: Bard implantable ports are indicated for patien...
Reason: Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9....
Z-1575-2020 April 1, 2020 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
1. X-Port isp M.R.I Implantable Port, with Pre-Attached 9.6 F Open-Ended Single-Lumen Venous Catheter, REF:0607550, UDI:(01)00801741026195 2. X-Port isp M.R.I. Implantable Port, with Attachable 9.6F ...
Reason: Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9....
Z-1578-2020 April 1, 2020 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
1. Power Port isp M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, Ref: 1809660, UDI: (01)00801741027154 2. PowerPort isp M.R.I. Implantable Po...
Reason: Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9....
Z-1572-2020 April 1, 2020 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
1.PowerPort Implantable Port With Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter REF: 1709600, Air Guard, With suture Plugs, (01)00801741026720; 2. PowerPort Implantable Port With Attacha...
Reason: Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9....
Z-1570-2020 April 1, 2020 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
PowerFlow Implatable Apheresis IV Port with attachable 9.6 F ChronoFl x Open-Ended Single-Lumen Venous Catheter, Ref A710962, UDI:(01)00801741129438 Product Usage: Bard implantable ports are indicat...
Reason: Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9....
Z-1579-2020 April 1, 2020 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
1. Vaccess CT Power-Injectable Implantable Port with Suture Plugs, Ref: 7496000, UDI:(01)00801741027482 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated ac...
Reason: Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9....
Z-1573-2020 April 1, 2020 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
BardPort M.R.I. Implantable Port with Attachale 9.6 F Open-Ended Single-Lumen Venous Catheter, REF: 0602680, UDI:(01)00801741025679 Product Usage: Bard implantable ports are indicated for patient the...
Reason: Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9....
Z-1576-2020 April 1, 2020 Tempe, AZ
Cook Inc.
Class II Terminated
Spectrum Central Venous Catheter Tray, Irrigation Catheter, Reference Part Number C-UDLMY-401 J-ABRM-HC-IHl-FST, Order Number G48053
Reason: The printed expiration dates are incorrect.
Z-1566-2020 April 1, 2020 Bloomington, IN
Boston Scientific Corporation
Class I Ongoing
Imager II 5F Angiographic Catheters, 5 units per package.
Reason: Potential for tip detachment of Imager II 5F Angiographic Catheters
Z-1555-2020 April 1, 2020 Maple Grove, MN
Bard Peripheral Vascular Inc
Class II Terminated
1. PowerPort M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, REF: 1809600, UDI: (01)00801741027130 ; 2. PowerPort M.R.I. Implantable Port wit...
Reason: Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9....
Z-1571-2020 April 1, 2020 Tempe, AZ
Cook Inc.
Class II Terminated
Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number G10643
Reason: The printed expiration dates are incorrect.
Z-1565-2020 April 1, 2020 Bloomington, IN
Bard Peripheral Vascular Inc
Class II Terminated
1. Groshong 9.5 Dual-Lumen CV Catheter, Ref: 7726950, UDI: (01)00801741041570; 2. Groshong 9.5 F Dual-Lumen CV Catheter, REF: 7726954, UDI: (01)00801741041587
Reason: Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9....
Z-1574-2020 April 1, 2020 Tempe, AZ
Cordis Corporation
Class II Terminated
Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
Reason: Cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for body/shaft voids in the proximal seal area.
Z-1477-2020 March 18, 2020 Miami Lakes, FL
RESPIRATORY THERAPEUTICS GROUP LLC
Class II Ongoing
RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm (14F), Length: 30.5cm (12in.), MDI Adapter, Cont. 10 Closed Suction Catheter, Sterile R, RxOnly, Reorder Number: RTG-02300, U...
Reason: It has been determined that some units of catheters were not tightly connected to the thumb port. This may result in the catheter disconnecting from the thumb port which could redu...
Z-1443-2020 March 11, 2020 Los Angeles, CA
Abbott Vascular
Class I Terminated
NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC Traveler RX 4.0 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-1141-2020 February 26, 2020 Temecula, CA
Abbott Vascular
Class I Terminated
NC TREK Coronary Dilatation Catheter, REF 1012455-15 Rx Only,NC TREK RX 5.00 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-1138-2020 February 26, 2020 Temecula, CA
Arrow International Inc
Class II Terminated
Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1
Reason: Product lidstock contains the incorrect expiration date for the product
Z-1236-2020 February 26, 2020 Reading, PA
Arrow International Inc
Class II Terminated
Arrow EPIDURAL CATHETERIZATION KIT AM-05500
Reason: Product lidstock contains the incorrect expiration date for the product
Z-1248-2020 February 26, 2020 Reading, PA
Arrow International Inc
Class II Terminated
Arrow EPIDURAL CATHETERIZATION KIT JH-05500
Reason: Product lidstock contains the incorrect expiration date for the product
Z-1247-2020 February 26, 2020 Reading, PA
Arrow International Inc
Class II Terminated
Arrow¿ EPIDURAL CATHETERIZATION KIT AK-05000
Reason: Product lidstock contains the incorrect expiration date for the product
Z-1245-2020 February 26, 2020 Reading, PA
Abbott Vascular
Class I Terminated
NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00 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-1128-2020 February 26, 2020 Temecula, CA
Abbott Vascular
Class I Terminated
NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00 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-1139-2020 February 26, 2020 Temecula, CA
Abbott Vascular
Class I Terminated
NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00 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-1129-2020 February 26, 2020 Temecula, CA
Abbott Vascular
Class I Terminated
NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler RX 4.5 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-1143-2020 February 26, 2020 Temecula, CA