Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 113 of 138
Boston Scientific Corp
Class II Terminated
IntellaTip MiFi XP Asymmetric (N4) Curve, 7/110/2.5/8-8 OUS; Material Number: M004EPM4500N40; Catalog number: EPM4500N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption ...
Reason: During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in BSC's product risk doc...
Z-0462-2016 December 30, 2015 San Jose, CA
Boston Scientific Corp
Class II Terminated
IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-8 Material Number: M004PM4500N40; Catalog number: PM4500N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of acces...
Reason: During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in BSCs product risk docu...
Z-0464-2016 December 30, 2015 San Jose, CA
Boston Scientific Corp
Class II Terminated
IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 OUS; Material Number: M004EPM4790N40; Catalog number: EPM4790N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption ...
Reason: During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in BSCs product risk docu...
Z-0463-2016 December 30, 2015 San Jose, CA
Boston Scientific Corp
Class II Terminated
IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 ; Material Number: M004PM4790N40; Catalog number: PM4790N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of ac...
Reason: During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in BSC's product risk doc...
Z-0465-2016 December 30, 2015 San Jose, CA
Stryker Instruments Div. of Stryker Corporation
Class II Terminated
Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units per case The Stryker Guidewire Introducer Needles are designed for the percutaneous puncture of the anterior/posterior wal...
Reason: The Guidewire Introducer Needle (0910-192-000) was shipped after the documented expiration date or with minimal time until expiration. There is a potential risk of a soft tissue i...
Z-0417-2016 December 23, 2015 Portage, MI
Cook Inc.
Class II Terminated
VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain.
Reason: Cook Medical initiated a voluntary recall of specific lot numbers of the VentriClear II Ventricular Drainage Catheter Set due to the device being sterilized twice, which may result...
Z-0416-2016 December 23, 2015 Bloomington, IN
LeMaitre Vascular, Inc.
Class II Terminated
LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for the removal of arterial emboli and thrombi.
Reason: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Z-0384-2016 December 16, 2015 Burlington, MA
LeMaitre Vascular, Inc.
Class II Terminated
LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88. Indicated for the removal of arterial emboli and thrombi.
Reason: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Z-0381-2016 December 16, 2015 Burlington, MA
LeMaitre Vascular, Inc.
Class II Terminated
LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78. Indicated for the removal of arterial emboli and thrombi.
Reason: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Z-0382-2016 December 16, 2015 Burlington, MA
LeMaitre Vascular, Inc.
Class II Terminated
LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68. Indicated for the removal of arterial emboli and thrombi.
Reason: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Z-0389-2016 December 16, 2015 Burlington, MA
LeMaitre Vascular, Inc.
Class II Terminated
LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicated for the removal of arterial emboli and thrombi.
Reason: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Z-0379-2016 December 16, 2015 Burlington, MA
LeMaitre Vascular, Inc.
Class II Terminated
LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48. Indicated for the removal of arterial emboli and thrombi.
Reason: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Z-0387-2016 December 16, 2015 Burlington, MA
LeMaitre Vascular, Inc.
Class II Terminated
LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34. Indicated for the removal of arterial emboli and thrombi.
Reason: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Z-0378-2016 December 16, 2015 Burlington, MA
LeMaitre Vascular, Inc.
Class II Terminated
LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. Indicated for the removal of arterial emboli and thrombi.
Reason: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Z-0385-2016 December 16, 2015 Burlington, MA
LeMaitre Vascular, Inc.
Class II Terminated
LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58. Indicated for the removal of arterial emboli and thrombi.
Reason: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Z-0388-2016 December 16, 2015 Burlington, MA
LeMaitre Vascular, Inc.
Class II Terminated
LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26. Indicated for the removal of arterial emboli and thrombi.
Reason: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Z-0390-2016 December 16, 2015 Burlington, MA
LeMaitre Vascular, Inc.
Class II Terminated
LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38. Indicated for the removal of arterial emboli and thrombi.
Reason: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Z-0386-2016 December 16, 2015 Burlington, MA
LeMaitre Vascular, Inc.
Class II Terminated
LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48. Indicated for the removal of arterial emboli and thrombi.
Reason: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Z-0380-2016 December 16, 2015 Burlington, MA
LeMaitre Vascular, Inc.
Class II Terminated
LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. Indicated for the removal of arterial emboli and thrombi.
Reason: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Z-0383-2016 December 16, 2015 Burlington, MA
Baylis Medical Corp *
Class II Terminated
ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires. Coa...
Reason: Microcatheter may have circumferential defects (cracks) along its shaft.
Z-0356-2016 December 9, 2015 Montreal
Procedure Products, Inc.
Class II Terminated
U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-sterile, and intended for further processing. Needles are packaged in zipper-bags, 300 pieces per bag, ...
Reason: The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle
Z-0355-2016 December 9, 2015 Vancouver, WA
Covidien LLC
Class II Terminated
Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042 The Palindrome chronic catheter is intended for acute and chronic hemodia...
Reason: Incorrectly packaged with a 90 degree bend at the distal tip
Z-0329-2016 December 2, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042P The Palindrome chronic catheter is intended for acute and chroni...
Reason: Incorrectly packaged with a 90 degree bend at the distal tip
Z-0331-2016 December 2, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145017P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apher...
Reason: Incorrectly packaged with a 90 degree bend at the distal tip
Z-0330-2016 December 2, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft and Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145061P The Palindrome chronic catheter is intended...
Reason: Incorrectly packaged with a 90 degree bend at the distal tip
Z-0333-2016 December 2, 2015 North Haven, CT