Loading

URGENT MEDICAL DEVICE RECALL
Medtronic Interventional Wires and ATTAIN HYBRID® Guide Wires

Model and Lot Numbers: See Attached List


October 21, 2013

Dear Risk Manager:

Medtronic has identified the potential for an issue with a specific subset of lot numbers of the Medtronic Interventional Wires and ATTAIN HYBRID® Guidewires where the PTFE (polytetrafluoroethylene) coating could delaminate and detach from the Guidewire. As a result, we are recalling the Guidewires from specific lots as noted in the attached list. This issue affects a subset of the following Medtronic Guidewires manufactured from mid April 2013:

Cougar® NITINOL WORKHORSE GUIDEWIRE

COUGAR® Steerable Guidewire

Zinger® STAINLESS STEEL WORKHORSE GUIDEWIRE

ZINGER® Steerable Guidewire

Thunder® EXTRA-SUPPORT GUIDEWIRE

THUNDER® Steerable Guidewire

ProVia® CROSSING GUIDEWIRE

ATTAIN HYBRID® Guide Wire

Delamination and detachment of the PTFE coating may lead to embolic occlusion and thrombosis in coronary, cerebral, peripheral or pulmonary vasculature. Vascular thrombosis and/or occlusion have the potential to result in irreversible damage or injury to vital organs including myocardial infarction or stroke.

Through October 15, 2013, Medtronic has received a total of four (4) complaints related to this issue. Medtronic has received no reports of patient deaths as a result of this issue.

For affected product that has been used, no action is necessary and patients should continue to be managed in accordance with your standard patient management protocol.

Our records show that your facility has received one or more of these Guidewires, as shown in the attachment to this notification. Consequently, Medtronic requests you immediately take the following actions:

  1. Remove and quarantine all potentially affected Guidewires that remain in your inventory.
  2. Return the potentially affected Guidewires to Medtronic. A Medtronic representative can assist in facilitating the return and credit of product as necessary. If replacement product is needed, your Medtronic representative can assist you with identifying suitable replacement product.
  3. Complete the attached Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality.

Medtronic has taken the necessary steps to prevent any future shipment of the potentially affected product. Regulatory agencies will be notified about this recall as applicable.

Please share this notification with others in your organization as appropriate. If any Guidewires within the scope of this recall have been forwarded to another facility, please notify that facility accordingly and facilitate the retrieval of the affected product.

We apologize for the inconvenience this may cause you; please be assured that patient safety and product quality remain our primary concern. Should you have any questions, please contact your Medtronic representative.

Sincerely,
Chris Hadland
Chris Hadland
Vice President, Quality
Cardiac and Vascular Group

 

URGENT MEDICAL DEVICE RECALL
UPDATE: Additional Model and Lot Numbers
Medtronic Interventional Wires and ATTAIN HYBRID® Guide Wires Model and Lot Numbers


December 10, 2013

Affected Medtronic Model Numbers (additional model numbers added in December 2013 are in red):

15PROV300HS CGRLS190HS CGRXT300HJ LVCLS190S LVZRXT180J ZNGRMS180HJ
3PROV180HS CGRLS190S CGRXT300HS LVCXT190J LVZRXT180S ZNGRMS180HS
3PROV180SS CGRLS300HS CGRXT300J LVCXT190S THNDR190J ZNGRMS180S
3PROV300HS CGRLS300S CGRXT300S LVTNDR190S THNDR190S ZNGRS180HJ
3PROV300SS CGRXT190HJ GWR419478 LVZRLS180J THNDR300J ZNGRS180HS
9PROV180HS CGRXT190HS GWR419488 LVZRLS180S THNDR300S ZNGRS180S
9PROV180SS CGRXT190J GWR419688 LVZRMS180J ZNGRLS180HJ  
CGRLS190HJ CGRXT190S LVCLS190J LVZRMS180S ZNGRLS180HS  
 

Affected Medtronic Lot Numbers (additional lot numbers added in December 2013 are in red):

6752371 G13A00112 G13A00911 G13A01409 GT414 GV851
6752383 G13A00113 G13A00920 G13A01410 GU141 GV852
6752385 G13A00114 G13A00921 G13A01411 GU543 GV854
6759937 G13A00116 G13A00931 G13A01446 GU959 GV875
6759939 G13A00117 G13A00936 G13A01447 GV117 GV876
6759941 G13A00118 G13A00937 G13A01449 GV118 GV919
6769772 G13A00123 G13A00939 G13A01450 GV121 GV926
6781453 G13A00130 G13A00940 G13A01452 GV143 GV927
6781454 G13A00133 G13A00971 G13A01477 GV259 GW405
6781455 G13A00134 G13A00972 G13A01478 GV260 GW406
6808160 G13A00136 G13A00973 G13A01569 GV261 GW407
6808161 G13A00137 G13A00974 G13A01584 GV276 GW508
6808164 G13A00692 G13A00975 G13A01600 GV287 GW509
6808165 G13A00713 G13A00976 G13A01601 GV381 GW510
6808166 G13A00715 G13A00977 G13A01604 GV382 GW547
6808167 G13A00716 G13A00978 G13A01605 GV824 GW594
6831243 G13A00734 G13A00979 G13A01606 GV827 GW675
6840866 G13A00735 G13A00980 G13A01607 GV829 GW683
6840878 G13A00788 G13A00981 G13A01608 GV830 GW687
6840879 G13A00792 G13A00982 G13A01609 GV831 GW688
6866694 G13A00794 G13A01016 G13A01620 GV832 GW690
6866696 G13A00803 G13A01017 G13A01621 GV835 GW695
6866697 G13A00804 G13A01167 G13A01622 GV836 GW706
6873688 G13A00805 G13A01270 G13A01623 GV837 GW710
6873692 G13A00809 G13A01271 G13A01624 GV838 GW745
6873694 G13A00810 G13A01300 G13A01638 GV839 GW746
G13A00104 G13A00811 G13A01324 G13A01639 GV840 GW758
G13A00105 G13A00814 G13A01330 G13A01640 GV844 GW761
G13A00106 G13A00815 G13A01352 G13A01641 GV845 GW768
G13A00107 G13A00843 G13A01354 G13A01650 GV846  
G13A00108 G13A00870 G13A01355 G13A01651 GV847  
G13A00109 G13A00874 G13A01400 G13A01912 GV848  
G13A00110 G13A00910 G13A01401 G13A01938 GV849  

 

Last updated: 19 Dec 2013

Section Navigation