Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 89 of 138
Cook Inc.
Class II Terminated
Central Venous Catheter Set Triple Lumen Polyurethane, Catalog Identifier: C-UTLM-501J Product Usage: The central venous catheter is designed for treatment of critically ill patients and is sugges...
Reason: Central venous catheters may not fit over guide wire potentially causing procedure delay.
Z-0630-2018 February 21, 2018 Bloomington, IN
Cook Inc.
Class II Terminated
Central Venous Catheter Tray Triple Lumen Polyurethane, Catalog Identifier: C-UTLMYJ-501J Product Usage: The central venous catheter is designed for treatment of critically ill patients and is sug...
Reason: Central venous catheters may not fit over guide wire potentially causing procedure delay.
Z-0631-2018 February 21, 2018 Bloomington, IN
Medical Components, Inc dba MedComp
Class II Terminated
6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157 Product Usage: Indicated for patient therapies requiring repeat...
Reason: The kit was packaged with the incorrect introducer needle size. The label indicates the kit contains an 18G Needle w/Echo Tip. The kits were packaged with a 21G Needle w/Echo Tip.
Z-0533-2018 February 14, 2018 Harleysville, PA
Bard Access Systems Inc.
Class II Terminated
PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a poly tray with Tyvek lid within a header bag configuration or a breather bag configuration.
Reason: Possible leaks on the 3 Fr. Single lumen and 4 Fr. Dual lumen PowerPICC catheters at the luer hub extension leg junction.
Z-0536-2018 February 14, 2018 Salt Lake City, UT
Medtronic Neuromodulation
Class III Terminated
Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 00643169202122, 00643169783027 (b) 8781, UDI: 00643169202139 (c) 8784, UDI: 00643169202153 The Ascenda Intrathecal Catheter k...
Reason: There is a possibility that specific lots of catheters that have recently been distributed may be at risk for an increased potential for kinking at the proximal end where the cathe...
Z-0537-2018 February 14, 2018 Minneapolis, MN
Edwards Lifesciences, LLC
Class II Terminated
Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). Product Usage: The HemoSphere Advanced Monitor (H...
Reason: Pre-procedural issues related to software defects
Z-0496-2018 February 7, 2018 Irvine, CA
Stryker Neurovascular
Class II Terminated
Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter
Reason: Stryker Neurovascular has become aware that at least 1 (one) Trevo XP Provue System was manufactured where the carton sleeve did not match the physical contents of the pack.
Z-0347-2018 January 24, 2018 Fremont, CA
Edwards Lifesciences, LLC
Class I Terminated
Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The Edwards Certitude Delivery System is used for delivery of the Edwards...
Reason: A component in the Certitude Loader may have a molding overflow defect that could detach during advancement of the delivery system and potentially embolize from the loader into t...
Z-0293-2018 January 17, 2018 Draper, UT
Sterilmed Inc
Class I Terminated
St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single u...
Reason: Inadequate seal due to lack of adhesive glue
Z-0213-2018 January 3, 2018 Minneapolis, MN
Stryker Neurovascular
Class II Terminated
Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, .Excelsior(TM) XT-27(TM) 1 TIP STRAIGHT, 150 cm, 6 cm, Microcatheter; UPN 93068 Stroke intervention kit
Reason: Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not...
Z-0277-2018 December 27, 2017 Fremont, CA
Stryker Neurovascular
Class II Terminated
Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 mm, ; Trevo(TM) Pro 18, TREVO PRO 18 MICROCATHETER, 0.021 in ID, 150 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 ...
Reason: Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not...
Z-0276-2018 December 27, 2017 Fremont, CA
Stryker Neurovascular
Class II Terminated
Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm), MICROCATHETER,150 cm, 6 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm, UPN M...
Reason: Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not...
Z-0275-2018 December 27, 2017 Fremont, CA
Biosense Webster, Inc.
Class II Terminated
PENTARAY NAV High-Density Mapping Catheter.
Reason: Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.
Z-0212-2018 December 13, 2017 Irwindale, CA
Biosense Webster, Inc.
Class II Terminated
PENTARAY NAV High-Density Mapping Catheter.
Reason: Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.
Z-0211-2018 December 13, 2017 Irwindale, CA
Arrow International Inc
Class II Terminated
Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market avail...
Reason: There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.
Z-0179-2018 December 6, 2017 Reading, PA
Arrow International Inc
Class II Terminated
ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for ...
Reason: There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.
Z-0182-2018 December 6, 2017 Reading, PA
Medline Industries Inc
Class II Terminated
MEDLINE PEDI ELBOW CLOSED SUCTION CATHETER, 8Fr, REF DYNCPE8
Reason: Products labeled as sterile were distributed prior to sterilization
Z-0112-2018 November 29, 2017 Northfield, IL
Medline Industries Inc
Class II Terminated
MEDLINE DOUBLE SWIVEL CLOSED SUCTION CATHETER, 21.3 in (54 cm) FOR ENDOTRACHEAL TUBE, 12 Fr, REF DYNCSDS12, 1 Each, Sterile
Reason: Products labeled as sterile were distributed prior to sterilization
Z-0113-2018 November 29, 2017 Northfield, IL
ICU Medical, Inc.
Class II Terminated
SURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 Drop Admin Set w/3-Way Stopcock, 1 Ext, Luer Slip Item No. B30167; 32" Transfer Set w/3-Way Stopcock, Clamp, Rotating Lue...
Reason: ICU Medical has identified certain stopcocks that are incorporated in IV sets may contain a metallic burr.
Z-0106-2018 November 29, 2017 San Clemente, CA
Windstone Medical Packaging, Inc.
Class II Terminated
AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.
Reason: Custom surgical kits were manufactured with part #63310 Catheter Urethral 10FR 16" which were subsequently recalled by CR Bard for a potential sterile barrier breach.
Z-0069-2018 November 15, 2017 Billings, MT
Epimed International
Class II Terminated
RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 19g or Smaller Catheter
Reason: Potential for partially incomplete seal of product, impacting sterility.
Z-0087-2018 November 15, 2017 Farmers Branch, TX
Biosense Webster, Inc.
Class II Terminated
THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)
Reason: Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand cathet...
Z-0057-2018 November 8, 2017 Irwindale, CA
Biosense Webster, Inc.
Class II Terminated
THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S)
Reason: Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand cathet...
Z-0056-2018 November 8, 2017 Irwindale, CA
Biosense Webster, Inc.
Class II Terminated
THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S
Reason: Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand cathet...
Z-0058-2018 November 8, 2017 Irwindale, CA
Biosense Webster, Inc.
Class II Terminated
THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S
Reason: Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand cathet...
Z-0054-2018 November 8, 2017 Irwindale, CA