The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0685-2018·Announced 2018-02-28

Boston Scientific Recalls Innova Self-Expanding Stent Systems Due to Release Defect

Boston Scientific is recalling 22,916 units of the Innova Self-Expanding Stent System because the stent may not fully release from the delivery system.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, meeting the criteria for a High severity score.

Plain-English summary

Boston Scientific Corporation is recalling 22,916 units of the Innova Self-Expanding Stent System, 200 mm. The recall is being conducted because the stent may be unable to be fully released from the delivery system. The affected devices are indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery and/or proximal popliteal artery.

The recall covers eight specific material configurations, including Innova 5 x 200 x 130, Innova 5 x 200 x 75, Innova 6 x 200 x 130, Innova 6 x 200 x 75, Innova 7 x 200 x 130, Innova 7 x 200 x 75, Innova 8 x 200 x 130, and Innova 8 x 200 x 75. Specific batch numbers for each configuration are listed in the official FDA recall record Z-0685-2018.

The affected devices were distributed worldwide, including nationwide distribution across the United States and internationally to Canada. The source text does not specify the number of patients affected or report any specific injuries or illnesses associated with this defect. Healthcare providers and patients should consult the FDA recall notice for specific instructions on how to proceed with affected devices.

The recalled product

Product
Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the…
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Vascular Stent
Hazard
Affected units
22,916

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • a. Innova 5 x 200 x 130 (Batch No. 18095733
  • 18137885
  • 18233108
  • 18379812
  • 18362996
  • 18420576
  • 18404859
  • 18457350
  • 18478823
  • 18488703
  • 18519986
  • 18696468
  • 18670333
  • 18667082
  • 18756979
  • 18855752
  • 18844729
  • 18872178
  • 18886680
  • 18866631

Distribution

Distributed nationwide across the United States.

The notice also names 47 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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