FDA Medical Device Recalls (openFDA)
Edwards Lifesciences, Llc: Edwards LifeSciences, Percutaneous Sheath Introducer Set, Rx only, For single use only. Indicated for use in patients requiring access of the venous system or to facilitate catheter insertion.
- Recall number
- Z-1913-2009
- Recalling firm
- Edwards Lifesciences, Llc
- Product
- Edwards LifeSciences, Percutaneous Sheath Introducer Set, Rx only, For single use only. Indicated for use in patients requiring access of the venous system or to facilitate catheter insertion.
- Status
- Terminated
- Initiated
- 2009-05-11
- Posted
- 2009-08-25
- Terminated
- 2012-02-23
- Reason
- Edwards LifeSciences LLC received several complaints, in which the blue connector of the introducer assembly has broken (fracture/separation) after several hours of use.
- Root cause
- Nonconforming Material/Component
- Action
- Edwards LifeSciences LLC initiated the worldwide recall via customer letters dated May 11, 2009 and are being sent by Federal Express stating that customers cease using affected product from the indicated lots and return all unused products. The firm requested that the customer provide written verification of stock and identify any unused product to be returned. For further information, contact Edwards LifeSciences LLC Customer Service at 1-800-424-3278.
- Quantity
- 67,357 Units
- Distribution
- Worldwide Distribution: United States (AL, AR, CA, CO, CT, DC, FL, GA, IA, IL, IN,KS, KY, MA, MD, ME, MI, MO, MS, ND, NH, NJ, NM, NV, NY, OH, PA, RI, SC, TN, TX, VA, WV, HI and PR), Austria, Canada, Switzerland, Czech,republic, Germany, Denmark, Algeria, Estonia, Egypt, Spain, Finland, France, Great Britain, Hungary, Iceland, Ireland, Italy, Kuwait, Lithuania, Luxembourg, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Russia, Sweden, Slovak republic, Tunisia, Turkey, Aruba, Hong Kong, Malaysia and Singapore.
- Lot, serial or model codes
- Model Number: 1350BF85, Lot Numbers: 58501071, 58516969, 58545402, 58568606, 58584153, 58606248, 58624009, 58648809, 58503807, 58532828, 58549292, 58573256, 58594977, 58611630, 58626772, 58652695, 58511627, 58536781, 58552776, 58576340, 58598946, 58611631, 58630984, 58653740, 58516967, 58536782, 58559223, 58577684, 58602066, 58618047, 58636148, 58653741, 58516968, 58541155, 58559224, 58577685, 58606247, 5864008 and 58645016; Model Number: 1351BF7, Lot Numbers: 58530069, 58545403, 58598947 and 58657088; Model Number: 1351BF85H, Lot Numbers: 58526054, 58532992, 58534647, 58552777, 58559225, 58576341, 58594979, 58594980, 58598948, 58602067, 58624011, 58630985, 58636149, 58648810 and 58657097; Model Number: 1450BF85, Lot Numbers: 58511628, 58516970, 58577686, 58589282, 58598949, 58615054, 58624015, 58635275 and 58664034; Model Number: 1451BF6, Lot Numbers: 58506614, 58526055, 58562341, 58577589, 58594981, 58615056, 58621700, 58635275, 58657143 and 58664035; Model Number: 1451BF8, Lot Numbers: 58511629, 58514509, 58514513, 58530070, 58532829, 58541156, 58549294, 58556099, 58564225, 58568607, 58573257, 58584154, 58602069, 58606249, 58610319, 58615059, 58621701, 58648811, 58652696, 58660278 and 58685275; Model Number: 1452BF85H, Lot Numbers: 58503809, 58549295, 58576343, 58611633, 58630986 and 586652697; Model Number: 1550BF6C, Lot Numbers: 58499574, 58501074, 58530071, 58532830, 58562343, 58602070, 58626774 and 58652698; Model Number: 1550BF7C, Lot Numbers: 58564227, 58577700 and 58657145; Model Number: 1550BF8, Lot Numbers: 58499575, 58526057, 58549298, 58560116, 58564228 and 58573260; Model Number: 1550BF85, Lot Numbers: 58501075, 58530072, 58534652, 58536809, 58577701, 58598950, 58618048 and 58657146; Model Number: 1551BF85H, Lot Numbers: 58615062, 58630987 and 58652699; Model Number: 1650BF85, Lot Numbers: 58545404, 58564229, 58584155, 58589283, 58618049, 58645018 and 58660284; Model Number: 1651BF85, Lot Numbers: 58499633, 58501080, 58511630, 58541157, 58556100, 58559226, 58584156, 58602071, 58615072, 58621702, 58645019 and 58652700; Model Number: 1652BF85H, Lot Numbers: 58511631, 58549300, 58606253 and 58648812; Model Number: S310740C, Lot Number: 58550203; and Model Number: S5507BF85, Lot Numbers: 58496258, 58535112, 58604814 and 58644423.
- 510(k) numbers
- K981909
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 2015691
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28