Medical Device Recall #29398 | Medicaldevicehub

CFRES ID:	91982
Device Name:	N/A
Product RES Number:	Z-1849-2010
Event Date Initiated:	2010-05-17
Event Date Posted:	2010-06-25
Event Date Created:	N/A
Event Date Terminated:	2011-10-20
Recall Status:	Terminated
Res Event Number:	55784
Product Code:	JCT
K Numbers:	["K012883"]
PMA Numbers:	N/A
Product Description:	Ultraflex Tracheobronchial Stent System. Covered - 18/40/25 Catalog Number: M00569540. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.
Code Info:	Lot Numbers: 9681425 9702667 9702668 9717705 9805013 9805176 9826460 9826461 11043810 11044745 11079254 11079255 11115641 11115646 11127080 11127082 11148822 11148823 11172971 11173298 11201028 11201034 11262987 11263514 11459616 11459617 11481585 11481640 11518709 11533436 11533880 11584312 11584453 11603850 11603853 11633581 11633583 11669424 11669428 11684387 11684393 11739270 11769537 11769538 1179911211799114 11837690 11847111 11847112 11875168 11875169 11912282 11912363 11949659 11949878 11997274 11999499 12030707 12031033 12068405 12068412 12127111 12127202 12155219 12155460 12161853 12161858 12168047 12170976 12171120 12189009 12236551 12236553 12252017 12256858 12256859 12273744 12273745 12286484 12286486 12375402 12408323 12433248 12444657 12515840 12550410 12581110 12632664 12644160 12687082 12748618 12765279 12845905 12862780 12865729 12915206 12950476 12964896 12969284 12972706 13075787 13106646 13173446 13176567 13193882 13242715 13262862 13264738
Recalling Firm:	Boston Scientific Corporation
Firm FEI Number:	N/A
Adress 1:	100 Boston Scientific Way
Adress 2:	N/A
City:	Marlborough
State:	MA
Postal Code:	01752-1234
Additional Contact Info:	same 508-683-8000
Reason for Recall:	Suture related device failures during deployment and repositioning of the stent
Root Cause Description:	Device Design
Other Submission Description:	N/A
Action:	Boston Scientific issued an "Urgent Medical Device Recall - Immediate Action Required" notification dated May 17, 2010 to U.S. Distributors stating that use and distribution of products should cease immediately and return all affected product to the firm for replacement. Distributors were asked to complete and return reply a verification tracking form. For further information, contact Boston Scientific at 1-866-868-4004.
Product Quantity:	N/A
Distribution Pattern:	Worldwide Distribution - Only US distributed product is affected by recall
Medical Speciality Description:	N/A
Regulation Number:	N/A
Event Date Posted:	2010-06-25
Device Class:	N/A
Open FDA:	{"k_number"=>["K023811", "K031641", "K033990", "K013648", "K030947", "K961296", "K945494", "K140382", "K024178", "K891411", "K071604", "K021901", "K980163", "K041269", "K000001", "K030567", "K050832", "K031041", "K003100", "K033053", "K964121", "K990221", "K982184", "K152842", "K961507", "K934116", "K062511", "K083625", "K201342", "K032744", "K121048", "K220424", "K082284", "K181200", "K140472", "K141584", "K212403", "K992510", "K050814", "K963241", "K012544", "K202204", "K001257", "K021563"], "registration_number"=>["3008516548", "9681260", "1721676", "3013440400", "3005099803", "1820334", "3000247987", "3010665433", "1000121056", "1220477", "1123137", "3010173425", "1721504", "3009582362", "3009906660", "3008146331", "3006950086", "3011458193", "3004837686", "3011175548", "3002807314", "3013337852", "1724474", "3002807090"], "fei_number"=>["3002807036", "3008516548", "1000123180", "1721676", "3003094851", "3013440400", "3005099803", "1820334", "3000247987", "3010665433", "1000121056", "1220477", "1721504", "3009582362", "3009906660", "3008146331", "3006950086", "3011458193", "3002806565", "3004837686", "3011175548", "3002807314", "3013337852", "3006003617"], "device_name"=>"Prosthesis, Tracheal, Expandable", "medical_specialty_description"=>"General, Plastic Surgery", "regulation_number"=>"878.3720", "device_class"=>"2"}

CFRES ID:

91982

Device Name:

N/A

Product RES Number:

Z-1849-2010

Event Date Initiated:

2010-05-17

Event Date Posted:

2010-06-25

Event Date Created:

N/A

Event Date Terminated:

2011-10-20

Recall Status:

Terminated

Res Event Number:

55784

Product Code:

JCT

K Numbers:

["K012883"]

PMA Numbers:

N/A

Product Description:

Ultraflex Tracheobronchial Stent System. Covered - 18/40/25 Catalog Number: M00569540. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.

Code Info:

Lot Numbers: 9681425 9702667 9702668 9717705 9805013 9805176 9826460 9826461 11043810 11044745 11079254 11079255 11115641 11115646 11127080 11127082 11148822 11148823 11172971 11173298 11201028 11201034 11262987 11263514 11459616 11459617 11481585 11481640 11518709 11533436 11533880 11584312 11584453 11603850 11603853 11633581 11633583 11669424 11669428 11684387 11684393 11739270 11769537 11769538 1179911211799114 11837690 11847111 11847112 11875168 11875169 11912282 11912363 11949659 11949878 11997274 11999499 12030707 12031033 12068405 12068412 12127111 12127202 12155219 12155460 12161853 12161858 12168047 12170976 12171120 12189009 12236551 12236553 12252017 12256858 12256859 12273744 12273745 12286484 12286486 12375402 12408323 12433248 12444657 12515840 12550410 12581110 12632664 12644160 12687082 12748618 12765279 12845905 12862780 12865729 12915206 12950476 12964896 12969284 12972706 13075787 13106646 13173446 13176567 13193882 13242715 13262862 13264738

Recalling Firm:

Boston Scientific Corporation

Firm FEI Number:

N/A

Adress 1:

100 Boston Scientific Way

Adress 2:

N/A

City:

Marlborough

State:

MA

Postal Code:

01752-1234

Additional Contact Info:

same 508-683-8000

Reason for Recall:

Suture related device failures during deployment and repositioning of the stent

Root Cause Description:

Device Design

Other Submission Description:

N/A

Action:

Boston Scientific issued an "Urgent Medical Device Recall - Immediate Action Required" notification dated May 17, 2010 to U.S. Distributors stating that use and distribution of products should cease immediately and return all affected product to the firm for replacement. Distributors were asked to complete and return reply a verification tracking form. For further information, contact Boston Scientific at 1-866-868-4004.

Product Quantity:

N/A

Distribution Pattern:

Worldwide Distribution - Only US distributed product is affected by recall

Medical Speciality Description:

N/A

Regulation Number:

N/A

Event Date Posted:

2010-06-25

Device Class:

N/A

Open FDA:

{"k_number"=>["K023811", "K031641", "K033990", "K013648", "K030947", "K961296", "K945494", "K140382", "K024178", "K891411", "K071604", "K021901", "K980163", "K041269", "K000001", "K030567", "K050832", "K031041", "K003100", "K033053", "K964121", "K990221", "K982184", "K152842", "K961507", "K934116", "K062511", "K083625", "K201342", "K032744", "K121048", "K220424", "K082284", "K181200", "K140472", "K141584", "K212403", "K992510", "K050814", "K963241", "K012544", "K202204", "K001257", "K021563"], "registration_number"=>["3008516548", "9681260", "1721676", "3013440400", "3005099803", "1820334", "3000247987", "3010665433", "1000121056", "1220477", "1123137", "3010173425", "1721504", "3009582362", "3009906660", "3008146331", "3006950086", "3011458193", "3004837686", "3011175548", "3002807314", "3013337852", "1724474", "3002807090"], "fei_number"=>["3002807036", "3008516548", "1000123180", "1721676", "3003094851", "3013440400", "3005099803", "1820334", "3000247987", "3010665433", "1000121056", "1220477", "1721504", "3009582362", "3009906660", "3008146331", "3006950086", "3011458193", "3002806565", "3004837686", "3011175548", "3002807314", "3013337852", "3006003617"], "device_name"=>"Prosthesis, Tracheal, Expandable", "medical_specialty_description"=>"General, Plastic Surgery", "regulation_number"=>"878.3720", "device_class"=>"2"}

Detailed Result for Z-1849-2010