Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 138 of 138
Terumo Cardiovascular Systems Corporation
Class II Terminated
MAYO MN XCOATED 3/8X1/2 AV Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to...
Reason: During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of som...
Z-1885-2012 July 4, 2012 Ann Arbor, MI
Terumo Cardiovascular Systems Corporation
Class II Terminated
Sarns Antegrade Cardioplegia Cannula: ROOT INFUSTION VENT CATHETER WITH 12 GAUGE BLUE NEEDLE RECTANGULAR FLANGE, 6" (15 CM) LONG Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent...
Reason: During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of som...
Z-1875-2012 July 4, 2012 Ann Arbor, MI
Boston Scientific Corporation
Class II Terminated
Boston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00562551 Inner Pouch: M00562550 The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which ca...
Reason: Difficulty in extending snare loop from the catheter
Z-1851-2012 June 27, 2012 Marlborough, MA
Terumo Cardiovascular Systems Corporation
Class II Terminated
CUSTOM CPB CATHETER KIT-DR. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Reason: During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae ...
Z-1841-2012 June 27, 2012 Ann Arbor, MI
Boston Scientific Corporation
Class II Terminated
Boston Scientific Profile Single-Use Pediatric Snare 27mm UPN Outer Box: M00562571 Inner Pouch: M00562570 The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which ca...
Reason: Difficulty in extending snare loop from the catheter
Z-1852-2012 June 27, 2012 Marlborough, MA
Terumo Cardiovascular Systems Corporation
Class II Terminated
CPB CATHETER KIT- DR.VAN TRIGHT. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Reason: During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae ...
Z-1842-2012 June 27, 2012 Ann Arbor, MI
Boston Scientific Corporation
Class II Terminated
Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M00562531 Inner Pouch: M00562530 , The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which c...
Reason: Difficulty in extending snare loop from the catheter
Z-1850-2012 June 27, 2012 Marlborough, MA
Arrow International Inc
Class II Terminated
Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter - Catalog number CDC-42703-XP1A The multiple-lumen pressure injectable catheter permits ven...
Reason: Arrow is recalling the product due to the possibility of voids in the catheter hub which could lead to an interlumen crossover.
Z-1823-2012 June 27, 2012 Reading, PA
Vygon Corporation
Class II Terminated
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter...
Reason: Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock...
Z-1798-2012 June 20, 2012 Montgomeryville, PA
Vygon Corporation
Class II Terminated
Churchill Medical Systems, Inc. A VYGON COMPANY PICC INSERTION TRAY Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
Reason: Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock...
Z-1808-2012 June 20, 2012 Montgomeryville, PA
Vygon Corporation
Class II Terminated
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 1 Unit per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box Prefilled syringes are used to maintain the patency of indwelling catheter lumens
Reason: Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock...
Z-1797-2012 June 20, 2012 Montgomeryville, PA
Vygon Corporation
Class II Terminated
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling cathete...
Reason: Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock...
Z-1800-2012 June 20, 2012 Montgomeryville, PA
Vygon Corporation
Class II Terminated
Churchill Medical Systems, Inc. DRESSING CHANGE KIT Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
Reason: Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock...
Z-1807-2012 June 20, 2012 Montgomeryville, PA
Vygon Corporation
Class II Terminated
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling cathete...
Reason: Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock...
Z-1801-2012 June 20, 2012 Montgomeryville, PA
Vygon Corporation
Class II Terminated
Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
Reason: Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock...
Z-1806-2012 June 20, 2012 Montgomeryville, PA
Vygon Corporation
Class II Terminated
Churchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit Prefilled syringes included in the tray kit are used to maintain the patency of indwelling catheter lumens
Reason: Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock...
Z-1802-2012 June 20, 2012 Montgomeryville, PA
Vygon Corporation
Class II Terminated
Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
Reason: Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock...
Z-1805-2012 June 20, 2012 Montgomeryville, PA
Vygon Corporation
Class II Terminated
Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
Reason: Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock...
Z-1804-2012 June 20, 2012 Montgomeryville, PA
Vygon Corporation
Class II Terminated
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter...
Reason: Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock...
Z-1799-2012 June 20, 2012 Montgomeryville, PA
Vygon Corporation
Class II Terminated
Churchill Medical Systems, Inc. PORT-A-CATH Tray Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
Reason: Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock...
Z-1803-2012 June 20, 2012 Montgomeryville, PA