Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 32 of 138
Covidien Llc
Class I Ongoing
Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Reason: There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated flu...
Z-1315-2022 July 13, 2022 Mansfield, MA
Covidien Llc
Class I Ongoing
Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Reason: There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated flu...
Z-1320-2022 July 13, 2022 Mansfield, MA
Covidien Llc
Class I Ongoing
Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Reason: There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated flu...
Z-1318-2022 July 13, 2022 Mansfield, MA
Covidien Llc
Class I Ongoing
Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
Reason: There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated flu...
Z-1314-2022 July 13, 2022 Mansfield, MA
Volcano Corp
Class III Ongoing
Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
Reason: Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
Z-1301-2022 July 6, 2022 San Diego, CA
Volcano Corp
Class III Ongoing
Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
Reason: Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
Z-1302-2022 July 6, 2022 San Diego, CA
Atrium Medical Corporation
Class II Ongoing
Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum. Product REF Number: 15028
Reason: Mismatch between the expiration date on the sterile barrier pouch and the expiration date on the case/shipper label. Product sterile barrier pouch label expiration date of 16SEP202...
Z-1297-2022 July 6, 2022 Merrimack, NH
Bard Peripheral Vascular Inc
Class II Ongoing
REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,
Reason: There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle. They can be used in conjunction with the following drainage methods: Uni...
Z-1273-2022 June 29, 2022 Tempe, AZ
Baxter Healthcare Corporation
Class II Terminated
Locking Cap for PD Catheter Adapter
Reason: Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
Z-1142-2022 June 8, 2022 Deerfield, IL
Abbott
Class II Terminated
FIRMap" Catheter, 60mm Basket
Reason: Incorrect product labeling.
Z-1213-2022 June 8, 2022 Plymouth, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Ongoing
The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a catheter dilator to...
Reason: The firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility.
Z-1206-2022 June 8, 2022 Mounds View, MN
Busse Hospital Disposables, Inc.
Class II Terminated
I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822
Reason: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to unce...
Z-1147-2022 June 8, 2022 Hauppauge, NY
Atrium Medical Corporation
Class I Ongoing
iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405 85406 85407 85408 85409 85410 85411 85412 85413 85414 85415 85416 85417 85418 85419 854...
Reason: Firm has observed increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system withdrawal causing pr...
Z-1077-2022 May 25, 2022 Merrimack, NH
Abbott Vascular
Class I Ongoing
Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
Reason: There is a potential that the proximal marker may separate from the imaging catheter
Z-1095-2022 May 25, 2022 Temecula, CA
Atrium Medical Corporation
Class I Ongoing
Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85326 85327 85328 85329 85330 85331 85332 85333 85334 85335 85336 85337 85338 8533...
Reason: Firm has observed increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system withdrawal causing pr...
Z-1076-2022 May 25, 2022 Merrimack, NH
Medtronic Vascular, Inc.
Class II Ongoing
Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only
Reason: Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
Z-1043-2022 May 18, 2022 Santa Rosa, CA
Medtronic Vascular, Inc.
Class II Ongoing
Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model Numbers:ADM04004013P ADM04008013P ADM04008013P ADM04008013P ADM04012013P ADM04015013P ADM...
Reason: Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
Z-1042-2022 May 18, 2022 Santa Rosa, CA
Freudenberg Medical, Llc
Class II Terminated
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
Reason: Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia
Z-1016-2022 May 4, 2022 Jeffersonville, IN
Freudenberg Medical, Llc
Class II Terminated
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)
Reason: Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia
Z-1017-2022 May 4, 2022 Jeffersonville, IN
Abbott
Class II Ongoing
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.
Reason: Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
Z-0957-2022 April 27, 2022 Plymouth, MN
Medtronic Inc
Class I Ongoing
Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
Reason: There is potential for the capsule bond to break during the procedure.
Z-0927-2022 April 27, 2022 Minneapolis, MN
Abbott
Class II Ongoing
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.
Reason: Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
Z-0956-2022 April 27, 2022 Plymouth, MN
Avanos Medical, Inc.
Class II Terminated
BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter; Sterile; Single Use
Reason: Product was distributed with incorrect expiration date.
Z-0845-2022 April 6, 2022 Alpharetta, GA
Avanos Medical, Inc.
Class II Terminated
BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French; Sterile; Single Use
Reason: Product was distributed with incorrect expiration date.
Z-0847-2022 April 6, 2022 Alpharetta, GA
Avanos Medical, Inc.
Class II Terminated
BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French; Sterile; Single Use
Reason: Product was distributed with incorrect expiration date.
Z-0846-2022 April 6, 2022 Alpharetta, GA