Medical Device Recall #29397 | Medicaldevicehub

CFRES ID:	91991
Device Name:	N/A
Product RES Number:	Z-1855-2010
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. Uncovered - 14/40 Catalog Number: M00569920. 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: 9667182 9667456 9678329 976661r 9783326 9784576 11005496 11005821 11055376 11109805 11110365 11111487 11111488 11124327 11124679 11129759 11182502 11203182 11203183 11219588 11219589 11262131 11277906 11279304 11320864 11320865 11327239 11327427 11379196 11379197 11389643 11389684 11466799 11514285 11514449 11551574 11551706 11603424 11609889 11609897 11621871 11621875 11723618 11741602 11741603 11790710 11790804 11824403 11842316 11900249 11900251 11965095 11965222 12018497 12018498 12072815 12072849 12124056 12124286 12126719 I 12182401 12182408 12203718 12203719 12233126 12273963 12273964 12311839 12344667 12350349 12355457 12414762 12503049 12573392 12634334 12673096 12730542 12741518 12749444 12763036 12828633 12883686 12954041 13068696 13104060 13176719 13203739 13204940 13209979
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:

91991

Device Name:

N/A

Product RES Number:

Z-1855-2010

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. Uncovered - 14/40 Catalog Number: M00569920. 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: 9667182 9667456 9678329 976661r 9783326 9784576 11005496 11005821 11055376 11109805 11110365 11111487 11111488 11124327 11124679 11129759 11182502 11203182 11203183 11219588 11219589 11262131 11277906 11279304 11320864 11320865 11327239 11327427 11379196 11379197 11389643 11389684 11466799 11514285 11514449 11551574 11551706 11603424 11609889 11609897 11621871 11621875 11723618 11741602 11741603 11790710 11790804 11824403 11842316 11900249 11900251 11965095 11965222 12018497 12018498 12072815 12072849 12124056 12124286 12126719 I 12182401 12182408 12203718 12203719 12233126 12273963 12273964 12311839 12344667 12350349 12355457 12414762 12503049 12573392 12634334 12673096 12730542 12741518 12749444 12763036 12828633 12883686 12954041 13068696 13104060 13176719 13203739 13204940 13209979

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-1855-2010