Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 71 of 138
Edwards Lifesciences, LLC
Class I Terminated
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239
Reason: The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system fr...
Z-2224-2019 August 28, 2019 Irvine, CA
Santanello Surgical LLC
Class II Terminated
VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot suction/irrigation catheter
Reason: Lack of package integrity may compromise sterility
Z-2237-2019 August 21, 2019 Columbus, OH
Degania Silicone, Ltd.
Class II Terminated
Smith & Nephew Negative Pressure Wound Therapy 15FR Channel Wound Drain PN: 02872 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to...
Reason: 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional sur...
Z-2267-2019 August 21, 2019 Dganya Bet, N/A
Degania Silicone, Ltd.
Class II Terminated
Cardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce...
Reason: 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional sur...
Z-2260-2019 August 21, 2019 Dganya Bet, N/A
Degania Silicone, Ltd.
Class II Terminated
Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar Cardinal Health: PN JP-2225 An introduction/drainage catheter is a device that is a flexible single or multilumen tube in...
Reason: 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional sur...
Z-2265-2019 August 21, 2019 Dganya Bet, N/A
Degania Silicone, Ltd.
Class II Terminated
Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar Cardinal Health: PN: JP-2191 An introduction/drainage catheter is a device that is a flexible single or multilumen tube i...
Reason: 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional sur...
Z-2264-2019 August 21, 2019 Dganya Bet, N/A
Degania Silicone, Ltd.
Class II Terminated
Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes Cardinal Health: PN JP-2190 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be ...
Reason: 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional sur...
Z-2263-2019 August 21, 2019 Dganya Bet, N/A
Degania Silicone, Ltd.
Class II Terminated
Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar Product Number: JP-2189 An introduction/drainage catheter is a device that is a flexible single or multilumen tube i...
Reason: 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional sur...
Z-2262-2019 August 21, 2019 Dganya Bet, N/A
Degania Silicone, Ltd.
Class II Terminated
Medline Silicone Drain 15Fr 3/16" Full Fluted PN: DYNJWE2188HB An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug...
Reason: 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional sur...
Z-2266-2019 August 21, 2019 Dganya Bet, N/A
Degania Silicone, Ltd.
Class II Terminated
Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes Cardinal Health PN: JP-2188 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to b...
Reason: 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional sur...
Z-2261-2019 August 21, 2019 Dganya Bet, N/A
Ra Medical Systems Inc
Class II Terminated
The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occluded lesions in the peripheral arteries to cross them. The system is a self-con...
Reason: Lasers/Catheters did not calibrate during set-up prior to use.
Z-2218-2019 August 14, 2019 Carlsbad, CA
Medical Components, Inc dba MedComp
Class II Terminated
14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425 Product Usage: An aid for introducing a hemodialysis catheter
Reason: Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
Z-2217-2019 August 14, 2019 Harleysville, PA
Medical Components, Inc dba MedComp
Class II Terminated
14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423 Product Usage: An aid for introducing a hemodialysis catheter
Reason: Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
Z-2215-2019 August 14, 2019 Harleysville, PA
Medical Components, Inc dba MedComp
Class II Terminated
14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424 Product Usage: An aid for introducing a hemodialysis catheter
Reason: Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
Z-2216-2019 August 14, 2019 Harleysville, PA
Epimed International, Inc.
Class II Terminated
Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 31129344 for epidural or caudal anesthesia
Reason: Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge...
Z-2069-2019 July 31, 2019 Johnstown, NY
InfuTronix LLC
Class II Terminated
Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a catheter.
Reason: Potential for tube leakage
Z-2055-2019 July 31, 2019 Natick, MA
Bard Peripheral Vascular Inc
Class II Completed
POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 6F CHRON...
Reason: Certain NAUTILUS DELTA Port Kit product code / lot number combinations may be at risk of experiencing a lack of or a loss of the intravascular ECG signal during port placement proc...
Z-2080-2019 July 31, 2019 Tempe, AZ
Epimed International, Inc.
Class II Terminated
Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 311291155 for epidural or caudal anesthesia
Reason: Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge c...
Z-2068-2019 July 31, 2019 Johnstown, NY
Datascope Corporation
Class II Terminated
Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage: The Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories ...
Reason: The device was distributed with the outer carton labeled with the manufacture date and the expiry date reversed. This showed the product as expired before it was manufactured.
Z-1966-2019 July 24, 2019 Fairfield, NJ
COVIDIEN LLC
Class II Terminated
MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009 8813816005 8813816009 8813817005 8813817009 8815668007 8815668011 8815668021 8...
Reason: The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for Use (IFU) are higher than the volumes required to fill each lumen.
Z-1955-2019 July 17, 2019 Mansfield, MA
Becton Dickinson & Company
Class I Terminated
Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414, 10933805, 11171447, 11404930, 11522558, 11607704, 10013361T, 2110-0500, 2126-0500, 2200-0500, 2411-0500, 2419-00...
Reason: An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The issue has the potential to lead ...
Z-1770-2019 July 17, 2019 Franklin Lakes, NJ
Cook Inc.
Class I Terminated
Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/50cm, Catalog Number ASB5-35-50-6-4, REF Number G35248 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter i...
Reason: Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in t...
Z-1756-2019 June 26, 2019 Bloomington, IN
Arrow International Inc
Class II Terminated
Arrow¿ JACC with Chlorag+ard¿ Technology Jugular Axillo subclavian Central Catheter Product Code: CDC 42563 JX1A
Reason: Lidstock states the incorrect expiration date for the product
Z-1803-2019 June 26, 2019 Reading, PA
Arrow International Inc
Class II Terminated
Arrow JACC with Chlorag+ard Technology Jugular Axillo subclavian Central Catheter Product Code: CDC 42552 JX1A
Reason: Lidstock states the incorrect expiration date for the product
Z-1802-2019 June 26, 2019 Reading, PA
Arrow International Inc
Class II Terminated
Arrow¿ JACC with Chlorag+ard¿ Technology Jugular Axillosubclavian Central Catheter Product Code: CDC 43063 JX1A
Reason: Lidstock states the incorrect expiration date for the product
Z-1804-2019 June 26, 2019 Reading, PA