• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Devices

  • Print
  • Share
  • E-mail

Boston Scientific Innova Self-Expanding Stent System

Recall Class: Class I

Date Recall Initiated: May 19, 2011

Product(s): Boston Scientific Innova Over-the-Wire Self-Expanding Stent System. 505 devices are subject to this recall.

Lot/ Serial Numbers:
14185610; 14186554; 14186392; 14212643; 14112648; 14222479; 14185609; 14186566; 14188380; 14190185; 14166907; 14208241; 14249236; 14271562; 14307650; 14312650; 14174799; 14207861; 14228329; 14175011; 14212647; 14312649; 14181569; 14201269; 14166906; 14184177; 14224203; 14231611; 14264850; 14264851; 14266959; 14270149; 14164683; 14194241; 14212645; 14218066; 14218447; 14229678; 14237239; 14245445; 14245447; 14245451; 14247059; 14197292; 14212642; 14264853; 14266955; 14266957; 14274756; 14292658; 14312539; 14166851; 14203523; 14238800; 14244222; 14247620; 14250456; 14251260; 14252968; 14301370; 14174210; 14201609; 14207860; 14264885; 14264856; 14166850; 14184178; 14222760; 14222761; 14230536; 14230537; 14230538; 14234498; 14236797; 14163858; 14186555; 14201320; 14201321; 14201606; 14209195; 14212644; 14216075; 14222762; 14166849; 14188392; 14222765; 14230539; 14230560; 14230561; 14237309; 14237310; 14238251; 14240739; 14301313; 14315579; 14318074; 14181570; 14209193; 14174794; 14204328; 14217705; 142866097; 14300372; 14307653; 14166854; 14194242; 14212103; 14212646; 14224204; 14264332; 14278123; 14279141; 14279142; 14315992; 14173148; 14204326; 14218451; 14241500; 14254515; 14297582; 14166902; 14203524; 14234815; 14252037; 14267965; 14279146; 14279147; 14307648; 14166900; 14212102; 14217146; 14278494; 14166853; 14184179; 14186567; 14229668; 14241791; 14256173; 14256174; 14256175; 14260901; 14312163; 14166852; 14186556; 14224202; 14243896; 14246803; 14246804; 14249237; 14250454; 14252035; 14296997; 4299010; 14166857; 14201607; 14201608; 14252966; 14252967; 14256375; 14279140; 14315578; 14181568; 14212649; 14250980; 14177592; 14218450; 14230566; 14174795; 14204329; 14230567; 14177585; 14207862; 14181571; 14181571; 14163857; 14184300; 14186568; 14198459; 14201266; 14201267; 14201268; 14209194; 14212641; 14214399; 14218441; 14218442; 14222767; 14222768; 14228777; 14286099; 14166856; 14190182; 14218448; 14222766; 14267441; 14267975; 14271561; 14300373; 14174209; 14204327; 14218449; 14282600; 14297398; 14185608; 14284696; 14186934; 14293503; 14190181; 14194561; 14185611; 14186553; 14187177; 14291945; 14190184; 14315577; 14187499; 14175010; 14278491; 14296355; 14181567; 14267440; 14320002; 14180942; 14214844; 14181975; 14203525; 14174200; 14289498; 14301368; 14319187; 14170917; 14247621; 14252036; 14255848; 14264852; 14267442; 14166905; 14266956; 14274757; 14289248; 14300697; 14312657; 14173640; 14263631; 14271563; 14278492; 14292561; 14292562; 14307644; 14180556; 14274013; 14300695; 14166903; 14255850; 14260681; 14260683; 14166901; 14229148; 14233623; 14233624; 14234800; 14297399; 14166909; 14243465; 14256372; 14256374; 14286202; 14293322; 14307654; 14319668; 14181976; 14250839; 14270152; 14177594; 14236053; 14177182; 14264339; 14281813; 14301369; 14312653; 14312654; 14177591; 14274012; 14279143; 14166908; 14289098; 14289099; 14289240; 14307647; 14315860; 14180946; 14266958; 14301371; 14315861; 14170918; 14270154; 14296995; 14296996; 14296998; 14166904; 14243466; 14243457; 14252033; 14252034; 14262898; 14173398; 14231610; 14267976; 14314825; 14181974; 14184301; 14186737; 14185607; 14188391; 14177596; 14260685; 14322569; 14180945; 14320003; 14193019; 14190183; 14322386; 14166859; 14229672; 14230562; 14230563; 14230564; 14230565; 14252965; 14300694; 14173399; 14278124; 14279275; 14288784; 4300374; 14177183; 14286201

Boston Scientific sent an urgent medical device recall letter to OUS customers on May 13, 2011. The recall notice explained the issue, identified the affected products, required distributors to cease further distribution and use of the product, and requested the return of unused product to Boston Scientific.

Reason for Recall: Complaints of no deployment and partial deployment have been received. This type of failure may result in vessel wall injury, increased procedure time and/or emergency surgery to remove the partially deployed stent. This recall does not affect stents that have already been implanted as the issue occurs during delivery of the stent.

Use: The Innova Stent System is intended for use in the treatment of symptomatic de novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery.

Recalling Firm:
Boston Scientific Corporation
1 Scimed Place
Maple Grove, MN 55311

Public Contact:
Boston Scientific Maple Grove Complaint Call Center: 1-800-811-3211. Or, Brent Hathcock, Field Action Team Lead at 763-494-7971.

FDA District: Minneapolis

FDA Comments:

Boston Scientific is advising customers to immediately discontinue use of any affected product and return all products to Boston Scientific.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

Useful Links: